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NCT02384239

A Study of Palbociclib in Combination With Fulvestrant or Tamoxifen as Treatment for Metastatic Breast Cancer

Version 8 to 9 · University of California, San Francisco

Patch inspector

Version 8 to 9

37 operations 6 path groups ctgov_internal_history
ClinicalTrials.gov
Severity is deterministic uncalibrated triage metadata, not validated review priority. Operation-level severity is inferred from deterministic path rules. Rule matches shown per operation are approximate previews (they skip the pipeline's suppression passes); the authoritative classification is the stored event record.
Plain-language summary

Manual review pending.

Rules fired
arms_or_interventions_change
Value signals
[
  {
    "path": "/protocolSection/statusModule/startDateStruct/date",
    "signal": "timeline_actual_date_correction",
    "category": "timeline_actual_date_correction",
    "new_type": "ACTUAL",
    "old_type": "ACTUAL",
    "severity": "low",
    "direction": "earlier",
    "new_value": "2015-10-19",
    "old_value": "2015-11-04",
    "delta_days": 16,
    "date_struct": "startDateStruct",
    "new_precision": "day",
    "old_precision": "day"
  },
  {
    "paths": [
      "/protocolSection/outcomesModule/primaryOutcomes/0/measure",
      "/protocolSection/outcomesModule/secondaryOutcomes/1/description",
      "/protocolSection/outcomesModule/secondaryOutcomes/1/measure",
      "/protocolSection/outcomesModule/secondaryOutcomes/1/timeFrame",
      "/protocolSection/outcomesModule/secondaryOutcomes/2/description",
      "/protocolSection/outcomesModule/secondaryOutcomes/2/measure",
      "/protocolSection/outcomesModule/secondaryOutcomes/2/timeFrame",
      "/protocolSection/outcomesModule/secondaryOutcomes/3",
      "/protocolSection/outcomesModule/secondaryOutcomes/4",
      "/protocolSection/outcomesModule/secondaryOutcomes/5"
    ],
    "signal": "results_reconciliation_outcome_suppression",
    "category": "results_reconciliation",
    "severity": "low"
  }
]
Provenance
Source
ctgov_internal_history
Fetched
2026-06-18 18:57:35+00
Raw hash
e978abf3ba96a5240a3359f327dd63a34418690bb9d0e971aacc1d0f835e6d97
Payload
Source URL
Primary outcomes Outcome measures that define the trial's primary evidence target. Triage: Critical 1 ops
replace /protocolSection/outcomesModule/primaryOutcomes/0/measure
Triage: Critical
Primary Outcome Change Operation 24
Matched rules
  • primary_outcome_any_change Any add/remove/replace under primary outcome measures is critical review priority.
Before
Percentage of participants with Grade 3 or 4 Neutropenia
After
Percentage of Participants With Grade 3 or 4 Neutropenia
Design Trial model, phase, allocation, masking, arms, or interventions. Triage: High 13 ops
replace /protocolSection/armsInterventionsModule/armGroups/0/label
Triage: High
Arm Intervention Change Operation 11
Matched rules
  • arms_or_interventions_change Arms or interventions changes can alter treatment/comparator structure.
Before
Palbociclib 100mg
After
Palbociclib 100mg and, fulvestrant or tamoxifen
replace /protocolSection/armsInterventionsModule/armGroups/0/description
Triage: High
Arm Intervention Change Operation 12
Matched rules
  • arms_or_interventions_change Arms or interventions changes can alter treatment/comparator structure.
Before
Treatment arm palbociclib dose 100mg + fulvestrant or tamoxifen
After
Palbociclib dose 100mg, and either fulvestrant (500 mg IM on days 1 and 15 in the first 28 days, then every 28 days thereafter) or tamoxifen (20 mg PO daily by physician choice)
add /protocolSection/armsInterventionsModule/armGroups/0/interventionNames/1
Triage: High
Arm Intervention Change Operation 13
Matched rules
  • arms_or_interventions_change Arms or interventions changes can alter treatment/comparator structure.
After
Drug: Tamoxifen
add /protocolSection/armsInterventionsModule/armGroups/0/interventionNames/2
Triage: High
Arm Intervention Change Operation 14
Matched rules
  • arms_or_interventions_change Arms or interventions changes can alter treatment/comparator structure.
After
Drug: Fulvestrant
replace /protocolSection/armsInterventionsModule/armGroups/1/label
Triage: High
Arm Intervention Change Operation 15
Matched rules
  • arms_or_interventions_change Arms or interventions changes can alter treatment/comparator structure.
Before
Palbociclib 125mg
After
Palbociclib 125mg and, fulvestrant or tamoxifen
replace /protocolSection/armsInterventionsModule/armGroups/1/description
Triage: High
Arm Intervention Change Operation 16
Matched rules
  • arms_or_interventions_change Arms or interventions changes can alter treatment/comparator structure.
Before
Treatment arm palbociclib dose 125mg + fulvestrant or tamoxifen
After
Palbociclib dose 125mg and either fulvestrant (500 mg IM on days 1 and 15 in the first 28 days, then every 28 days thereafter) or tamoxifen (20 mg PO daily by physician choice)
add /protocolSection/armsInterventionsModule/armGroups/1/interventionNames/1
Triage: High
Arm Intervention Change Operation 17
Matched rules
  • arms_or_interventions_change Arms or interventions changes can alter treatment/comparator structure.
After
Drug: Tamoxifen
add /protocolSection/armsInterventionsModule/armGroups/1/interventionNames/2
Triage: High
Arm Intervention Change Operation 18
Matched rules
  • arms_or_interventions_change Arms or interventions changes can alter treatment/comparator structure.
After
Drug: Fulvestrant
replace /protocolSection/armsInterventionsModule/interventions/0/armGroupLabels/0
Triage: High
Arm Intervention Change Operation 19
Matched rules
  • arms_or_interventions_change Arms or interventions changes can alter treatment/comparator structure.
Before
Palbociclib 100mg
After
Palbociclib 100mg and, fulvestrant or tamoxifen
replace /protocolSection/armsInterventionsModule/interventions/0/armGroupLabels/1
Triage: High
Arm Intervention Change Operation 20
Matched rules
  • arms_or_interventions_change Arms or interventions changes can alter treatment/comparator structure.
Before
Palbociclib 125mg
After
Palbociclib 125mg and, fulvestrant or tamoxifen
add /protocolSection/armsInterventionsModule/interventions/0/description
Triage: High
Arm Intervention Change Operation 21
Matched rules
  • arms_or_interventions_change Arms or interventions changes can alter treatment/comparator structure.
After
Given orally (PO)
add /protocolSection/armsInterventionsModule/interventions/1
Triage: High
Arm Intervention Change Operation 22
Matched rules
  • arms_or_interventions_change Arms or interventions changes can alter treatment/comparator structure.
After
{
  "name": "Tamoxifen",
  "type": "DRUG",
  "otherNames": [
    "Tamoxifen 20mg"
  ],
  "description": "Given orally (PO)",
  "armGroupLabels": [
    "Palbociclib 100mg and, fulvestrant or tamoxifen",
    "Palbociclib 125mg and, fulvestrant or tamoxifen"
  ]
}
add /protocolSection/armsInterventionsModule/interventions/2
Triage: High
Arm Intervention Change Operation 23
Matched rules
  • arms_or_interventions_change Arms or interventions changes can alter treatment/comparator structure.
After
{
  "name": "Fulvestrant",
  "type": "DRUG",
  "otherNames": [
    "Faslodex"
  ],
  "description": "Given by intramuscular (IM) injection.",
  "armGroupLabels": [
    "Palbociclib 100mg and, fulvestrant or tamoxifen",
    "Palbociclib 125mg and, fulvestrant or tamoxifen"
  ]
}
Secondary outcomes Additional endpoints and outcome descriptions. Triage: High 9 ops
replace /protocolSection/outcomesModule/secondaryOutcomes/1/measure
Triage: High
Secondary Outcome Change Operation 25
Matched rules
  • secondary_outcome_any_change Any add/remove/replace under secondary outcome measures is high review priority.
Before
Proportion of participants with demonstrated clinical benefit
After
Proportion of Participants With Demonstrated Clinical Benefit
replace /protocolSection/outcomesModule/secondaryOutcomes/1/description
Triage: High
Secondary Outcome Change Operation 26
Matched rules
  • secondary_outcome_any_change Any add/remove/replace under secondary outcome measures is high review priority.
Before
Defined as the proportion of patients whose best overall response, according to RECIST, is either complete response (CR), a partial response (PR) or stable disease (SD).
Only those patients who have measurable disease present at baseline, have received at least one cycle of therapy, and have had their disease re-evaluated will be considered evaluable for response.
After
Defined as the proportion of patients whose best overall response, according to RECIST, is either complete response (CR), a partial response (PR) or stable disease (SD) at 24 weeks.
Only those patients who have measurable disease present at baseline, have received at least one cycle of therapy, and have had their disease re-evaluated will be considered evaluable for response.
replace /protocolSection/outcomesModule/secondaryOutcomes/1/timeFrame
Triage: High
Secondary Outcome Change Operation 27
Matched rules
  • secondary_outcome_any_change Any add/remove/replace under secondary outcome measures is high review priority.
Before
Up to 24 weeks
After
24 weeks
replace /protocolSection/outcomesModule/secondaryOutcomes/2/measure
Triage: High
Secondary Outcome Change Operation 28
Matched rules
  • secondary_outcome_any_change Any add/remove/replace under secondary outcome measures is high review priority.
Before
Proportion of participants with an objective response
After
Proportion of Participants With an Objective Response
replace /protocolSection/outcomesModule/secondaryOutcomes/2/description
Triage: High
Secondary Outcome Change Operation 29
Matched rules
  • secondary_outcome_any_change Any add/remove/replace under secondary outcome measures is high review priority.
Before
Defined as the proportion of patients whose best overall response, according to RECIST, is either complete response (CR), a partial response (PR).
Only those patients who have measurable disease present at baseline, have received at least one cycle of therapy, and have had their disease re-evaluated will be considered evaluable for response.
After
Defined as the proportion of patients whose best overall response, according to RECIST, is either complete response (CR), a partial response (PR) at 24 weeks.
Only those patients who have measurable disease present at baseline, have received at least one cycle of therapy, and have had their disease re-evaluated will be considered evaluable for response.
replace /protocolSection/outcomesModule/secondaryOutcomes/2/timeFrame
Triage: High
Secondary Outcome Change Operation 30
Matched rules
  • secondary_outcome_any_change Any add/remove/replace under secondary outcome measures is high review priority.
Before
Up to 24 weeks
After
24 weeks
add /protocolSection/outcomesModule/secondaryOutcomes/3
Triage: High
Secondary Outcome Change Operation 31
Matched rules
  • secondary_outcome_any_change Any add/remove/replace under secondary outcome measures is high review priority.
After
{
  "measure": "Median Change in Percent Positive Cells From Baseline of Ki-67",
  "timeFrame": "Up to 24 months",
  "description": "Median change in percent positive cells of Ki-67 from baseline will be reported with IQR"
}
add /protocolSection/outcomesModule/secondaryOutcomes/4
Triage: High
Secondary Outcome Change Operation 32
Matched rules
  • secondary_outcome_any_change Any add/remove/replace under secondary outcome measures is high review priority.
After
{
  "measure": "Median Change in Percent Positive Cells From Baseline of Total-Rb",
  "timeFrame": "Up to 24 months",
  "description": "Median change in percent positive cells of Total-Rb from baseline will be reported with interquartile range (IQR)"
}
add /protocolSection/outcomesModule/secondaryOutcomes/5
Triage: High
Secondary Outcome Change Operation 33
Matched rules
  • secondary_outcome_any_change Any add/remove/replace under secondary outcome measures is high review priority.
After
{
  "measure": "Median Change in Percent Positive Cells From Baseline of pS780-Rb",
  "timeFrame": "Up to 24 months",
  "description": "Median change in percent positive cells of pS780-Rb from baseline will be reported with IQR"
}
Timeline Start, primary completion, and completion date movement. Triage: Medium 1 ops
replace /protocolSection/statusModule/startDateStruct/date
Triage: Medium
Timeline Shift Operation 2
Matched rules
  • start_timeline_change Start date changes are operational timeline signals.
Before
2015-11-04
After
2015-10-19
Other registry fields Changes outside the current high-signal rule families. Triage: Uncategorized 12 ops
replace /protocolSection/statusModule/statusVerifiedDate
Triage: Uncategorized
Uncategorized Operation 1
Before
2021-02
After
2022-02
replace /protocolSection/statusModule/lastUpdateSubmitDate
Triage: Uncategorized
Uncategorized Operation 3
Before
2021-02-03
After
2022-02-16
replace /protocolSection/statusModule/lastUpdatePostDateStruct/date
Triage: Uncategorized
Uncategorized Operation 4
Before
2021-02-05
After
2022-03-16
add /protocolSection/statusModule/resultsFirstSubmitDate
Triage: Uncategorized
Uncategorized Operation 5
After
2022-01-24
add /protocolSection/statusModule/resultsFirstSubmitQcDate
Triage: Uncategorized
Uncategorized Operation 6
After
2022-02-16
add /protocolSection/statusModule/resultsFirstPostDateStruct
Triage: Uncategorized
Uncategorized Operation 7
After
{
  "date": "2022-03-16",
  "type": "ACTUAL"
}
replace /protocolSection/descriptionModule/briefSummary
Triage: Uncategorized
Uncategorized Operation 9
Before
<p>Approximately 70 patients with hormone receptor positive (HR+) advanced breast cancer will be enrolled.
All patients will receive either fulvestrant (500 mg intramuscular (IM) every 2 weeks x 3 then every four weeks) or tamoxifen (20 mg orally daily by physician choice).
Pre-menopausal women must be in chemical menopause.</p><p>Arm 1 will receive palbociclib 100 mg qd, days 1-21 every 28 days.
Arm 2 will receive palbociclib 125 mg qd, days 1-21 every 28 days.
Restaging will be performed every 8 weeks.
Therapy will be continued until progressive disease (PD) or unacceptable toxicity.</p><p>Patients will be randomly allocated in a 1:1 ratio to take either 100 mg or 125 mg of palbociclib.
Randomized treatment assignments will be made by permuted blocks, generated by our collaborating statistician at Dana-Farber Cancer Institute.</p>
After
This phase II trial studies the side effects of palbociclib when given together with fulvestrant or tamoxifen citrate in treating patients with hormone receptor positive breast cancer that has spread from where it started to nearby tissue or lymph nodes (locally advanced) or has spread to other places in the body (metastatic).
Palbociclib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.
Hormone therapy using fulvestrant or tamoxifen citrate may fight breast cancer by blocking the use of estrogen by the tumor cells.
Giving palbociclib together with fulvestrant or tamoxifen citrate may work better in treating hormone receptor positive breast cancer.
add /protocolSection/descriptionModule/detailedDescription
Triage: Uncategorized
Uncategorized Operation 10
After
<p>Patients will be randomly allocated in a 1:1 ratio to take either 100 mg or 125 mg of palbociclib.
Randomized treatment assignments will be made by permuted blocks, generated by our collaborating statistician at Dana-Farber Cancer Institute.</p><p>PRIMARY OBJECTIVES:</p><p>I. To evaluate the incidence of grade 3&#x2F;4 neutropenia in patients with hormone receptor positive (HR+) advanced breast cancer previously exposed to chemotherapy, treated with fulvestrant or tamoxifen (tamoxifen citrate) in combination with palbociclib at a dose of 100mg or 125mg.</p><p>SECONDARY OBJECTIVES:</p><p>I. To evaluate progression-free survival with 100 mg and 125 mg dosing of palbociclib.</p><p>II.
To evaluate inhibition of retinoblastoma (RB) phosphorylation in tumor and in skin at 100 mg and 125 mg dosing of palbociclib.</p><p>III.
To evaluate the correlation between inhibition of RB phosphorylation in skin and tumor.</p><p>IV.
To evaluate the correlation between inhibition of RB phosphorylation and progression-free survival (PFS).</p><p>V. To evaluate the objective response and clinical benefit rate of palbociclib given at 100 mg or 125 mg.</p><p>VI.
To evaluate the toxicity associated with palbociclib given at 100 mg and 125 mg in combination with fulvestrant or tamoxifen.</p><p>VII.
To evaluate markers of resistance to palbociclib and fulvestrant or tamoxifen in circulating plasma tumor deoxyribonucleic acid (DNA) (ptDNA).</p><p>OUTLINE: Patients are randomized to 1 of 2 treatment arms.</p><p>ARM I: Patients receive low-dose palbociclib orally (PO) on days 1-21.
Patients also receive tamoxifen citrate PO on days 1-28 or fulvestrant intramuscularly (IM) on days 1 and 15 of cycle 1 and then on day 1 only in subsequent cycles.
Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.</p><p>ARM II: Patients receive high-dose palbociclib PO on days 1-21.
Patients also receive tamoxifen citrate PO on days 1-28 or fulvestrant IM on days 1 and 15 of cycle 1 and then on day 1 only in subsequent cycles.
Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.</p>
remove /annotationSection
Triage: Uncategorized
Uncategorized Operation 34
Before
{
  "annotationModule": {
    "unpostedAnnotation": {
      "unpostedEvents": [
        {
          "date": "2022-01-24",
          "type": "RELEASE"
        },
        {
          "date": "2022-02-16",
          "type": "RESET"
        }
      ],
      "unpostedResponsibleParty": "Hope Rugo, MD, Professor, University of California, San Francisco"
    }
  }
}
replace /hasResults
Triage: Uncategorized
Uncategorized Operation 35
Before
false
After
true
add /resultsSection
Triage: Uncategorized
Uncategorized Operation 36
After
{
  "moreInfoModule": {
    "pointOfContact": {
      "email": "Hope.Rugo@ucsf.edu",
      "phone": "(415) 353-7618",
      "title": "Dr. Hope Rugo, MD",
      "organization": "University of California, San Francisco"
    },
    "certainAgreement": {
      "piSponsorEmployee": true
    }
  },
  "adverseEventsModule": {
    "timeFrame": "Up to 24 months",
    "eventGroups": [
      {
        "id": "EG000",
        "title": "Palbociclib 100mg",
        "description": "Palbociclib dose 100mg and either fulvestrant (500 mg IM on days 1 and 15 in the first 28 days, then every 28 days thereafter) or tamoxifen (20 mg PO daily by physician choice)",
        "otherNumAtRisk": 36,
        "deathsNumAtRisk": 36,
        "otherNumAffected": 7,
        "seriousNumAtRisk": 36,
        "deathsNumAffected": 3,
        "seriousNumAffected": 5
      },
      {
        "id": "EG001",
        "title": "Palbociclib 125mg",
        "description": "Palbociclib dose 125mg and either fulvestrant (500 mg IM on days 1 and 15 in the first 28 days, then every 28 days thereafter) or tamoxifen (20 mg PO daily by physician choice)",
        "otherNumAtRisk": 34,
        "deathsNumAtRisk": 34,
        "otherNumAffected": 9,
        "seriousNumAtRisk": 34,
        "deathsNumAffected": 1,
        "seriousNumAffected": 2
      }
    ],
    "otherEvents": [
      {
        "term": "Neutrophil count decreased",
        "stats": [
          {
            "groupId": "EG000",
            "numAtRisk": 36,
            "numEvents": 12,
            "numAffected": 5
          },
          {
            "groupId": "EG001",
            "numAtRisk": 34,
            "numEvents": 19,
            "numAffected": 9
          }
        ],
        "organSystem": "Investigations",
        "assessmentType": "SYSTEMATIC_ASSESSMENT",
        "sourceVocabulary": "CTCAE (4.0)"
      },
      {
        "term": "Hypertension",
        "stats": [
          {
            "groupId": "EG000",
            "numAtRisk": 36,
            "numEvents": 2,
            "numAffected": 2
          },
          {
            "groupId": "EG001",
            "numAtRisk": 34,
            "numEvents": 0,
            "numAffected": 0
          }
        ],
        "organSystem": "Vascular disorders",
        "assessmentType": "SYSTEMATIC_ASSESSMENT",
        "sourceVocabulary": "CTCAE (4.0)"
      }
    ],
    "seriousEvents": [
      {
        "term": "Gastrointestinal disorders - Other",
        "stats": [
          {
            "groupId": "EG000",
            "numAtRisk": 36,
            "numEvents": 1,
            "numAffected": 1
          },
          {
            "groupId": "EG001",
            "numAtRisk": 34,
            "numEvents": 1,
            "numAffected": 1
          }
        ],
        "organSystem": "Gastrointestinal disorders",
        "assessmentType": "SYSTEMATIC_ASSESSMENT",
        "sourceVocabulary": "CTCAE (4.0)"
      },
      {
        "term": "Infections and infestations - Other",
        "stats": [
          {
            "groupId": "EG000",
            "numAtRisk": 36,
            "numEvents": 1,
            "numAffected": 1
          },
          {
            "groupId": "EG001",
            "numAtRisk": 34,
            "numEvents": 0,
            "numAffected": 0
          }
        ],
        "organSystem": "Infections and infestations",
        "assessmentType": "SYSTEMATIC_ASSESSMENT",
        "sourceVocabulary": "CTCAE (4.0)"
      },
      {
        "term": "Dehydration",
        "stats": [
          {
            "groupId": "EG000",
            "numAtRisk": 36,
            "numEvents": 0,
            "numAffected": 0
          },
          {
            "groupId": "EG001",
            "numAtRisk": 34,
            "numEvents": 1,
            "numAffected": 1
          }
        ],
        "organSystem": "Metabolism and nutrition disorders",
        "assessmentType": "SYSTEMATIC_ASSESSMENT",
        "sourceVocabulary": "CTCAE (4.0)"
      },
      {
        "term": "Pleural effusion",
        "stats": [
          {
            "groupId": "EG000",
            "numAtRisk": 36,
            "numEvents": 2,
            "numAffected": 2
          },
          {
            "groupId": "EG001",
            "numAtRisk": 34,
            "numEvents": 0,
            "numAffected": 0
          }
        ],
        "organSystem": "Respiratory, thoracic and mediastinal disorders",
        "assessmentType": "SYSTEMATIC_ASSESSMENT",
        "sourceVocabulary": "CTCAE (4.0)"
      },
      {
        "term": "Respiratory, thoracic and mediastinal disorders - Other",
        "stats": [
          {
            "groupId": "EG000",
            "numAtRisk": 36,
            "numEvents": 1,
            "numAffected": 1
          },
          {
            "groupId": "EG001",
            "numAtRisk": 34,
            "numEvents": 0,
            "numAffected": 0
          }
        ],
        "organSystem": "Respiratory, thoracic and mediastinal disorders",
        "assessmentType": "SYSTEMATIC_ASSESSMENT",
        "sourceVocabulary": "CTCAE (4.0)"
      }
    ],
    "frequencyThreshold": "5"
  },
  "outcomeMeasuresModule": {
    "outcomeMeasures": [
      {
        "type": "PRIMARY",
        "title": "Percentage of Participants With Grade 3 or 4 Neutropenia",
        "denoms": [
          {
            "units": "Participants",
            "counts": [
              {
                "value": "36",
                "groupId": "OG000"
              },
              {
                "value": "34",
                "groupId": "OG001"
              }
            ]
          }
        ],
        "groups": [
          {
            "id": "OG000",
            "title": "Palbociclib 100mg",
            "description": "Palbociclib dose 100mg, and either fulvestrant (500 mg IM on days 1 and 15 in the first 28 days, then every 28 days thereafter) or tamoxifen (20 mg PO daily by physician choice)"
          },
          {
            "id": "OG001",
            "title": "Palbociclib 125mg",
            "description": "Palbociclib dose 125mg and either fulvestrant (500 mg IM on days 1 and 15 in the first 28 days, then every 28 days thereafter) or tamoxifen (20 mg PO daily by physician choice)"
          }
        ],
        "classes": [
          {
            "categories": [
              {
                "measurements": [
                  {
                    "value": "19.4",
                    "groupId": "OG000"
                  },
                  {
                    "value": "20.5",
                    "groupId": "OG001"
                  }
                ]
              }
            ]
          }
        ],
        "paramType": "NUMBER",
        "timeFrame": "Up to 24 months",
        "description": "Grade 3&#x2F;4 neutropenia as defined by NCI Common Terminology Criteria for Adverse Events (CTCAE) v4.03 in patients with prior exposure to 1-3 lines of chemotherapy for metastatic breast cancer",
        "unitOfMeasure": "percentage of participants",
        "reportingStatus": "POSTED"
      },
      {
        "type": "SECONDARY",
        "title": "Progression-free Survival (PFS)",
        "denoms": [
          {
            "units": "Participants",
            "counts": [
              {
                "value": "36",
                "groupId": "OG000"
              },
              {
                "value": "34",
                "groupId": "OG001"
              }
            ]
          }
        ],
        "groups": [
          {
            "id": "OG000",
            "title": "Palbociclib 100mg",
            "description": "Palbociclib dose 100mg, and either fulvestrant (500 mg IM on days 1 and 15 in the first 28 days, then every 28 days thereafter) or tamoxifen (20 mg PO daily by physician choice)"
          },
          {
            "id": "OG001",
            "title": "Palbociclib 125mg",
            "description": "Palbociclib dose 125mg and either fulvestrant (500 mg IM on days 1 and 15 in the first 28 days, then every 28 days thereafter) or tamoxifen (20 mg PO daily by physician choice)"
          }
        ],
        "classes": [
          {
            "categories": [
              {
                "measurements": [
                  {
                    "value": "6.53",
                    "groupId": "OG000",
                    "lowerLimit": "2.33",
                    "upperLimit": "12.2"
                  },
                  {
                    "value": "9.4",
                    "groupId": "OG001",
                    "lowerLimit": "3.56",
                    "upperLimit": "19.7"
                  }
                ]
              }
            ]
          }
        ],
        "paramType": "MEDIAN",
        "timeFrame": "Up to 24 months",
        "description": "PFS defined as the interval from study entry to the first documented evidence of disease progression by Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 as at least a 20% increase in the sum of the longest diameter (SLD) of target lesions, taking as reference the smallest sum SLD recorded since the treatment started and minimum 5 mm increase over the nadir, or the appearance of one or more new lesions.\nPatients who remain progression-free at the time of analysis will be censored at their last date of follow-up.",
        "unitOfMeasure": "months",
        "dispersionType": "95% Confidence Interval",
        "reportingStatus": "POSTED"
      },
      {
        "type": "SECONDARY",
        "title": "Proportion of Participants With Demonstrated Clinical Benefit",
        "denoms": [
          {
            "units": "Participants",
            "counts": [
              {
                "value": "36",
                "groupId": "OG000"
              },
              {
                "value": "32",
                "groupId": "OG001"
              }
            ]
          }
        ],
        "groups": [
          {
            "id": "OG000",
            "title": "Palbociclib 100mg",
            "description": "Palbociclib dose 100mg, and either fulvestrant (500 mg IM on days 1 and 15 in the first 28 days, then every 28 days thereafter) or tamoxifen (20 mg PO daily by physician choice)"
          },
          {
            "id": "OG001",
            "title": "Palbociclib 125mg",
            "description": "Palbociclib dose 125mg and either fulvestrant (500 mg IM on days 1 and 15 in the first 28 days, then every 28 days thereafter) or tamoxifen (20 mg PO daily by physician choice)"
          }
        ],
        "classes": [
          {
            "categories": [
              {
                "measurements": [
                  {
                    "value": "0.67",
                    "groupId": "OG000"
                  },
                  {
                    "value": "0.75",
                    "groupId": "OG001"
                  }
                ]
              }
            ]
          }
        ],
        "paramType": "NUMBER",
        "timeFrame": "24 weeks",
        "description": "Defined as the proportion of patients whose best overall response, according to RECIST, is either complete response (CR), a partial response (PR) or stable disease (SD) at 24 weeks.\nOnly those patients who have measurable disease present at baseline, have received at least one cycle of therapy, and have had their disease re-evaluated will be considered evaluable for response.",
        "unitOfMeasure": "proportion of participants",
        "reportingStatus": "POSTED",
        "populationDescription": "Two participants in the 125mg group did not have an evaluable disease assessment 24 weeks"
      },
      {
        "type": "SECONDARY",
        "title": "Proportion of Participants With an Objective Response",
        "denoms": [
          {
            "units": "Participants",
            "counts": [
              {
                "value": "36",
                "groupId": "OG000"
              },
              {
                "value": "32",
                "groupId": "OG001"
              }
            ]
          }
        ],
        "groups": [
          {
            "id": "OG000",
            "title": "Palbociclib 100mg",
            "description": "Palbociclib dose 100mg, and either fulvestrant (500 mg IM on days 1 and 15 in the first 28 days, then every 28 days thereafter) or tamoxifen (20 mg PO daily by physician choice)"
          },
          {
            "id": "OG001",
            "title": "Palbociclib 125mg",
            "description": "Palbociclib dose 125mg and either fulvestrant (500 mg IM on days 1 and 15 in the first 28 days, then every 28 days thereafter) or tamoxifen (20 mg PO daily by physician choice)"
          }
        ],
        "classes": [
          {
            "categories": [
              {
                "measurements": [
                  {
                    "value": "0.1111",
                    "groupId": "OG000"
                  },
                  {
                    "value": "0.0625",
                    "groupId": "OG001"
                  }
                ]
              }
            ]
          }
        ],
        "paramType": "NUMBER",
        "timeFrame": "24 weeks",
        "description": "Defined as the proportion of patients whose best overall response, according to RECIST, is either complete response (CR), a partial response (PR) at 24 weeks.\nOnly those patients who have measurable disease present at baseline, have received at least one cycle of therapy, and have had their disease re-evaluated will be considered evaluable for response.",
        "unitOfMeasure": "proportion of participants",
        "reportingStatus": "POSTED",
        "populationDescription": "Two participants in the 125mg group did not have an evaluable disease assessment 24 weeks"
      },
      {
        "type": "SECONDARY",
        "title": "Median Change in Percent Positive Cells From Baseline of Ki-67",
        "denoms": [
          {
            "units": "Participants",
            "counts": [
              {
                "value": "36",
                "groupId": "OG000"
              },
              {
                "value": "34",
                "groupId": "OG001"
              }
            ]
          }
        ],
        "groups": [
          {
            "id": "OG000",
            "title": "Palbociclib 100mg",
            "description": "Palbociclib dose 100mg, and either fulvestrant (500 mg IM on days 1 and 15 in the first 28 days, then every 28 days thereafter) or tamoxifen (20 mg PO daily by physician choice)"
          },
          {
            "id": "OG001",
            "title": "Palbociclib 125mg",
            "description": "Palbociclib dose 125mg and either fulvestrant (500 mg IM on days 1 and 15 in the first 28 days, then every 28 days thereafter) or tamoxifen (20 mg PO daily by physician choice)"
          }
        ],
        "classes": [
          {
            "categories": [
              {
                "measurements": [
                  {
                    "value": "-8",
                    "groupId": "OG000",
                    "lowerLimit": "-22",
                    "upperLimit": "0"
                  },
                  {
                    "value": "-6",
                    "groupId": "OG001",
                    "lowerLimit": "-19",
                    "upperLimit": "-1"
                  }
                ]
              }
            ]
          }
        ],
        "paramType": "MEDIAN",
        "timeFrame": "Up to 24 months",
        "description": "Median change in percent positive cells of Ki-67 from baseline will be reported with IQR",
        "unitOfMeasure": "change in percent positive cells",
        "dispersionType": "Inter-Quartile Range",
        "reportingStatus": "POSTED"
      },
      {
        "type": "SECONDARY",
        "title": "Median Change in Percent Positive Cells From Baseline of Total-Rb",
        "denoms": [
          {
            "units": "Participants",
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              {
                "value": "36",
                "groupId": "OG000"
              },
              {
                "value": "34",
                "groupId": "OG001"
              }
            ]
          }
        ],
        "groups": [
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            "title": "Palbociclib 100mg",
            "description": "Palbociclib dose 100mg, and either fulvestrant (500 mg IM on days 1 and 15 in the first 28 days, then every 28 days thereafter) or tamoxifen (20 mg PO daily by physician choice)"
          },
          {
            "id": "OG001",
            "title": "Palbociclib 125mg",
            "description": "Palbociclib dose 125mg and either fulvestrant (500 mg IM on days 1 and 15 in the first 28 days, then every 28 days thereafter) or tamoxifen (20 mg PO daily by physician choice)"
          }
        ],
        "classes": [
          {
            "categories": [
              {
                "measurements": [
                  {
                    "value": "4",
                    "groupId": "OG000",
                    "lowerLimit": "-25",
                    "upperLimit": "30"
                  },
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                    "groupId": "OG001",
                    "lowerLimit": "-15",
                    "upperLimit": "29"
                  }
                ]
              }
            ]
          }
        ],
        "paramType": "MEDIAN",
        "timeFrame": "Up to 24 months",
        "description": "Median change in percent positive cells of Total-Rb from baseline will be reported with interquartile range (IQR)",
        "unitOfMeasure": "change in percent positive cells",
        "dispersionType": "Inter-Quartile Range",
        "reportingStatus": "POSTED"
      },
      {
        "type": "SECONDARY",
        "title": "Median Change in Percent Positive Cells From Baseline of pS780-Rb",
        "denoms": [
          {
            "units": "Participants",
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              {
                "value": "36",
                "groupId": "OG000"
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            ]
          }
        ],
        "groups": [
          {
            "id": "OG000",
            "title": "Palbociclib 100mg",
            "description": "Treatment arm palbociclib dose 100mg + fulvestrant or tamoxifen"
          },
          {
            "id": "OG001",
            "title": "Palbociclib 125mg",
            "description": "Palbociclib dose 125mg and either fulvestrant (500 mg IM on days 1 and 15 in the first 28 days, then every 28 days thereafter) or tamoxifen (20 mg PO daily by physician choice)"
          }
        ],
        "classes": [
          {
            "categories": [
              {
                "measurements": [
                  {
                    "value": "-3",
                    "groupId": "OG000",
                    "lowerLimit": "-32",
                    "upperLimit": "4"
                  },
                  {
                    "value": "-6",
                    "groupId": "OG001",
                    "lowerLimit": "-14",
                    "upperLimit": "12"
                  }
                ]
              }
            ]
          }
        ],
        "paramType": "MEDIAN",
        "timeFrame": "Up to 24 months",
        "description": "Median change in percent positive cells of pS780-Rb from baseline will be reported with IQR",
        "unitOfMeasure": "change in percent positive cells",
        "dispersionType": "Inter-Quartile Range",
        "reportingStatus": "POSTED"
      }
    ]
  },
  "participantFlowModule": {
    "groups": [
      {
        "id": "FG000",
        "title": "Palbociclib 100mg",
        "description": "Palbociclib dose 100mg, and either fulvestrant (500 mg intramuscular injection (IM) on days 1 and 15 in the first 28 days, then every 28 days thereafter) or tamoxifen (20 mg PO daily by physician choice)"
      },
      {
        "id": "FG001",
        "title": "Palbociclib 125mg",
        "description": "Palbociclib dose 125mg and either fulvestrant (500 mg IM on days 1 and 15 in the first 28 days, then every 28 days thereafter) or tamoxifen (20 mg PO daily by physician choice)"
      }
    ],
    "periods": [
      {
        "title": "Overall Study",
        "milestones": [
          {
            "type": "STARTED",
            "achievements": [
              {
                "groupId": "FG000",
                "numSubjects": "36"
              },
              {
                "groupId": "FG001",
                "numSubjects": "34"
              }
            ]
          },
          {
            "type": "COMPLETED",
            "achievements": [
              {
                "groupId": "FG000",
                "numSubjects": "36"
              },
              {
                "groupId": "FG001",
                "numSubjects": "34"
              }
            ]
          },
          {
            "type": "NOT COMPLETED",
            "achievements": [
              {
                "groupId": "FG000",
                "numSubjects": "0"
              },
              {
                "groupId": "FG001",
                "numSubjects": "0"
              }
            ]
          }
        ]
      }
    ]
  },
  "baselineCharacteristicsModule": {
    "denoms": [
      {
        "units": "Participants",
        "counts": [
          {
            "value": "36",
            "groupId": "BG000"
          },
          {
            "value": "34",
            "groupId": "BG001"
          },
          {
            "value": "70",
            "groupId": "BG002"
          }
        ]
      }
    ],
    "groups": [
      {
        "id": "BG000",
        "title": "Palbociclib 100mg",
        "description": "Palbociclib dose 100mg, and either fulvestrant (500 mg IM on days 1 and 15 in the first 28 days, then every 28 days thereafter) or tamoxifen (20 mg PO daily by physician choice)"
      },
      {
        "id": "BG001",
        "title": "Palbociclib 125mg",
        "description": "Palbociclib dose 125mg and either fulvestrant (500 mg IM on days 1 and 15 in the first 28 days, then every 28 days thereafter) or tamoxifen (20 mg PO daily by physician choice)"
      },
      {
        "id": "BG002",
        "title": "Total",
        "description": "Total of all reporting groups"
      }
    ],
    "measures": [
      {
        "title": "Age, Customized",
        "classes": [
          {
            "title": "30-39 years old",
            "categories": [
              {
                "measurements": [
                  {
                    "value": "1",
                    "groupId": "BG000"
                  },
                  {
                    "value": "0",
                    "groupId": "BG001"
                  },
                  {
                    "value": "1",
                    "groupId": "BG002"
                  }
                ]
              }
            ]
          },
          {
            "title": "40-49 years old",
            "categories": [
              {
                "measurements": [
                  {
                    "value": "5",
                    "groupId": "BG000"
                  },
                  {
                    "value": "7",
                    "groupId": "BG001"
                  },
                  {
                    "value": "12",
                    "groupId": "BG002"
                  }
                ]
              }
            ]
          },
          {
            "title": "50-59 years old",
            "categories": [
              {
                "measurements": [
                  {
                    "value": "11",
                    "groupId": "BG000"
                  },
                  {
                    "value": "15",
                    "groupId": "BG001"
                  },
                  {
                    "value": "26",
                    "groupId": "BG002"
                  }
                ]
              }
            ]
          },
          {
            "title": "60-69 years old",
            "categories": [
              {
                "measurements": [
                  {
                    "value": "12",
                    "groupId": "BG000"
                  },
                  {
                    "value": "5",
                    "groupId": "BG001"
                  },
                  {
                    "value": "17",
                    "groupId": "BG002"
                  }
                ]
              }
            ]
          },
          {
            "title": "70-79 years old",
            "categories": [
              {
                "measurements": [
                  {
                    "value": "5",
                    "groupId": "BG000"
                  },
                  {
                    "value": "6",
                    "groupId": "BG001"
                  },
                  {
                    "value": "11",
                    "groupId": "BG002"
                  }
                ]
              }
            ]
          },
          {
            "title": "80-89 years old",
            "categories": [
              {
                "measurements": [
                  {
                    "value": "2",
                    "groupId": "BG000"
                  },
                  {
                    "value": "1",
                    "groupId": "BG001"
                  },
                  {
                    "value": "3",
                    "groupId": "BG002"
                  }
                ]
              }
            ]
          }
        ],
        "paramType": "COUNT_OF_PARTICIPANTS",
        "unitOfMeasure": "Participants"
      },
      {
        "title": "Sex: Female, Male",
        "classes": [
          {
            "categories": [
              {
                "title": "Female",
                "measurements": [
                  {
                    "value": "36",
                    "groupId": "BG000"
                  },
                  {
                    "value": "33",
                    "groupId": "BG001"
                  },
                  {
                    "value": "69",
                    "groupId": "BG002"
                  }
                ]
              },
              {
                "title": "Male",
                "measurements": [
                  {
                    "value": "0",
                    "groupId": "BG000"
                  },
                  {
                    "value": "1",
                    "groupId": "BG001"
                  },
                  {
                    "value": "1",
                    "groupId": "BG002"
                  }
                ]
              }
            ]
          }
        ],
        "paramType": "COUNT_OF_PARTICIPANTS",
        "unitOfMeasure": "Participants"
      },
      {
        "title": "Ethnicity (NIH&#x2F;OMB)",
        "classes": [
          {
            "categories": [
              {
                "title": "Hispanic or Latino",
                "measurements": [
                  {
                    "value": "1",
                    "groupId": "BG000"
                  },
                  {
                    "value": "0",
                    "groupId": "BG001"
                  },
                  {
                    "value": "1",
                    "groupId": "BG002"
                  }
                ]
              },
              {
                "title": "Not Hispanic or Latino",
                "measurements": [
                  {
                    "value": "33",
                    "groupId": "BG000"
                  },
                  {
                    "value": "33",
                    "groupId": "BG001"
                  },
                  {
                    "value": "66",
                    "groupId": "BG002"
                  }
                ]
              },
              {
                "title": "Unknown or Not Reported",
                "measurements": [
                  {
                    "value": "2",
                    "groupId": "BG000"
                  },
                  {
                    "value": "1",
                    "groupId": "BG001"
                  },
                  {
                    "value": "3",
                    "groupId": "BG002"
                  }
                ]
              }
            ]
          }
        ],
        "paramType": "COUNT_OF_PARTICIPANTS",
        "unitOfMeasure": "Participants"
      },
      {
        "title": "Race (NIH&#x2F;OMB)",
        "classes": [
          {
            "categories": [
              {
                "title": "American Indian or Alaska Native",
                "measurements": [
                  {
                    "value": "0",
                    "groupId": "BG000"
                  },
                  {
                    "value": "0",
                    "groupId": "BG001"
                  },
                  {
                    "value": "0",
                    "groupId": "BG002"
                  }
                ]
              },
              {
                "title": "Asian",
                "measurements": [
                  {
                    "value": "1",
                    "groupId": "BG000"
                  },
                  {
                    "value": "2",
                    "groupId": "BG001"
                  },
                  {
                    "value": "3",
                    "groupId": "BG002"
                  }
                ]
              },
              {
                "title": "Native Hawaiian or Other Pacific Islander",
                "measurements": [
                  {
                    "value": "0",
                    "groupId": "BG000"
                  },
                  {
                    "value": "1",
                    "groupId": "BG001"
                  },
                  {
                    "value": "1",
                    "groupId": "BG002"
                  }
                ]
              },
              {
                "title": "Black or African American",
                "measurements": [
                  {
                    "value": "2",
                    "groupId": "BG000"
                  },
                  {
                    "value": "1",
                    "groupId": "BG001"
                  },
                  {
                    "value": "3",
                    "groupId": "BG002"
                  }
                ]
              },
              {
                "title": "White",
                "measurements": [
                  {
                    "value": "28",
                    "groupId": "BG000"
                  },
                  {
                    "value": "26",
                    "groupId": "BG001"
                  },
                  {
                    "value": "54",
                    "groupId": "BG002"
                  }
                ]
              },
              {
                "title": "More than one race",
                "measurements": [
                  {
                    "value": "0",
                    "groupId": "BG000"
                  },
                  {
                    "value": "0",
                    "groupId": "BG001"
                  },
                  {
                    "value": "0",
                    "groupId": "BG002"
                  }
                ]
              },
              {
                "title": "Unknown or Not Reported",
                "measurements": [
                  {
                    "value": "5",
                    "groupId": "BG000"
                  },
                  {
                    "value": "4",
                    "groupId": "BG001"
                  },
                  {
                    "value": "9",
                    "groupId": "BG002"
                  }
                ]
              }
            ]
          }
        ],
        "paramType": "COUNT_OF_PARTICIPANTS",
        "unitOfMeasure": "Participants"
      },
      {
        "title": "Region of Enrollment",
        "classes": [
          {
            "title": "United States",
            "categories": [
              {
                "measurements": [
                  {
                    "value": "36",
                    "groupId": "BG000"
                  },
                  {
                    "value": "34",
                    "groupId": "BG001"
                  },
                  {
                    "value": "70",
                    "groupId": "BG002"
                  }
                ]
              }
            ]
          }
        ],
        "paramType": "NUMBER",
        "unitOfMeasure": "participants"
      }
    ]
  }
}
add /documentSection
Triage: Uncategorized
Uncategorized Operation 37
After
{
  "largeDocumentModule": {
    "largeDocs": [
      {
        "date": "2017-03-01",
        "size": 12917068,
        "label": "Study Protocol and Statistical Analysis Plan",
        "hasIcf": false,
        "hasSap": true,
        "filename": "Prot_SAP_000.pdf",
        "typeAbbrev": "Prot_SAP",
        "uploadDate": "2021-11-22T21:31",
        "hasProtocol": true
      }
    ]
  }
}
Sponsor and administrative fields Sponsor, collaborator, oversight, or registry maintenance changes. Triage: Uncategorized 1 ops
add /protocolSection/sponsorCollaboratorsModule/collaborators
Triage: Uncategorized
Uncategorized Operation 8
After
[
  {
    "name": "Translational Breast Cancer Research Consortium",
    "class": "OTHER"
  },
  {
    "name": "Dana-Farber Cancer Institute",
    "class": "OTHER"
  }
]
Raw JSON Patch 
[
  {
    "op": "replace",
    "path": "/protocolSection/statusModule/statusVerifiedDate",
    "value": "2022-02"
  },
  {
    "op": "replace",
    "path": "/protocolSection/statusModule/startDateStruct/date",
    "value": "2015-10-19"
  },
  {
    "op": "replace",
    "path": "/protocolSection/statusModule/lastUpdateSubmitDate",
    "value": "2022-02-16"
  },
  {
    "op": "replace",
    "path": "/protocolSection/statusModule/lastUpdatePostDateStruct/date",
    "value": "2022-03-16"
  },
  {
    "op": "add",
    "path": "/protocolSection/statusModule/resultsFirstSubmitDate",
    "value": "2022-01-24"
  },
  {
    "op": "add",
    "path": "/protocolSection/statusModule/resultsFirstSubmitQcDate",
    "value": "2022-02-16"
  },
  {
    "op": "add",
    "path": "/protocolSection/statusModule/resultsFirstPostDateStruct",
    "value": {
      "date": "2022-03-16",
      "type": "ACTUAL"
    }
  },
  {
    "op": "add",
    "path": "/protocolSection/sponsorCollaboratorsModule/collaborators",
    "value": [
      {
        "name": "Translational Breast Cancer Research Consortium",
        "class": "OTHER"
      },
      {
        "name": "Dana-Farber Cancer Institute",
        "class": "OTHER"
      }
    ]
  },
  {
    "op": "replace",
    "path": "/protocolSection/descriptionModule/briefSummary",
    "value": "This phase II trial studies the side effects of palbociclib when given together with fulvestrant or tamoxifen citrate in treating patients with hormone receptor positive breast cancer that has spread from where it started to nearby tissue or lymph nodes (locally advanced) or has spread to other places in the body (metastatic).\nPalbociclib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.\nHormone therapy using fulvestrant or tamoxifen citrate may fight breast cancer by blocking the use of estrogen by the tumor cells.\nGiving palbociclib together with fulvestrant or tamoxifen citrate may work better in treating hormone receptor positive breast cancer."
  },
  {
    "op": "add",
    "path": "/protocolSection/descriptionModule/detailedDescription",
    "value": "<p>Patients will be randomly allocated in a 1:1 ratio to take either 100 mg or 125 mg of palbociclib.\nRandomized treatment assignments will be made by permuted blocks, generated by our collaborating statistician at Dana-Farber Cancer Institute.</p><p>PRIMARY OBJECTIVES:</p><p>I. To evaluate the incidence of grade 3&#x2F;4 neutropenia in patients with hormone receptor positive (HR+) advanced breast cancer previously exposed to chemotherapy, treated with fulvestrant or tamoxifen (tamoxifen citrate) in combination with palbociclib at a dose of 100mg or 125mg.</p><p>SECONDARY OBJECTIVES:</p><p>I. To evaluate progression-free survival with 100 mg and 125 mg dosing of palbociclib.</p><p>II.\nTo evaluate inhibition of retinoblastoma (RB) phosphorylation in tumor and in skin at 100 mg and 125 mg dosing of palbociclib.</p><p>III.\nTo evaluate the correlation between inhibition of RB phosphorylation in skin and tumor.</p><p>IV.\nTo evaluate the correlation between inhibition of RB phosphorylation and progression-free survival (PFS).</p><p>V. To evaluate the objective response and clinical benefit rate of palbociclib given at 100 mg or 125 mg.</p><p>VI.\nTo evaluate the toxicity associated with palbociclib given at 100 mg and 125 mg in combination with fulvestrant or tamoxifen.</p><p>VII.\nTo evaluate markers of resistance to palbociclib and fulvestrant or tamoxifen in circulating plasma tumor deoxyribonucleic acid (DNA) (ptDNA).</p><p>OUTLINE: Patients are randomized to 1 of 2 treatment arms.</p><p>ARM I: Patients receive low-dose palbociclib orally (PO) on days 1-21.\nPatients also receive tamoxifen citrate PO on days 1-28 or fulvestrant intramuscularly (IM) on days 1 and 15 of cycle 1 and then on day 1 only in subsequent cycles.\nCycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.</p><p>ARM II: Patients receive high-dose palbociclib PO on days 1-21.\nPatients also receive tamoxifen citrate PO on days 1-28 or fulvestrant IM on days 1 and 15 of cycle 1 and then on day 1 only in subsequent cycles.\nCycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.</p>"
  },
  {
    "op": "replace",
    "path": "/protocolSection/armsInterventionsModule/armGroups/0/label",
    "value": "Palbociclib 100mg and, fulvestrant or tamoxifen"
  },
  {
    "op": "replace",
    "path": "/protocolSection/armsInterventionsModule/armGroups/0/description",
    "value": "Palbociclib dose 100mg, and either fulvestrant (500 mg IM on days 1 and 15 in the first 28 days, then every 28 days thereafter) or tamoxifen (20 mg PO daily by physician choice)"
  },
  {
    "op": "add",
    "path": "/protocolSection/armsInterventionsModule/armGroups/0/interventionNames/1",
    "value": "Drug: Tamoxifen"
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  {
    "op": "add",
    "path": "/protocolSection/armsInterventionsModule/armGroups/0/interventionNames/2",
    "value": "Drug: Fulvestrant"
  },
  {
    "op": "replace",
    "path": "/protocolSection/armsInterventionsModule/armGroups/1/label",
    "value": "Palbociclib 125mg and, fulvestrant or tamoxifen"
  },
  {
    "op": "replace",
    "path": "/protocolSection/armsInterventionsModule/armGroups/1/description",
    "value": "Palbociclib dose 125mg and either fulvestrant (500 mg IM on days 1 and 15 in the first 28 days, then every 28 days thereafter) or tamoxifen (20 mg PO daily by physician choice)"
  },
  {
    "op": "add",
    "path": "/protocolSection/armsInterventionsModule/armGroups/1/interventionNames/1",
    "value": "Drug: Tamoxifen"
  },
  {
    "op": "add",
    "path": "/protocolSection/armsInterventionsModule/armGroups/1/interventionNames/2",
    "value": "Drug: Fulvestrant"
  },
  {
    "op": "replace",
    "path": "/protocolSection/armsInterventionsModule/interventions/0/armGroupLabels/0",
    "value": "Palbociclib 100mg and, fulvestrant or tamoxifen"
  },
  {
    "op": "replace",
    "path": "/protocolSection/armsInterventionsModule/interventions/0/armGroupLabels/1",
    "value": "Palbociclib 125mg and, fulvestrant or tamoxifen"
  },
  {
    "op": "add",
    "path": "/protocolSection/armsInterventionsModule/interventions/0/description",
    "value": "Given orally (PO)"
  },
  {
    "op": "add",
    "path": "/protocolSection/armsInterventionsModule/interventions/1",
    "value": {
      "name": "Tamoxifen",
      "type": "DRUG",
      "otherNames": [
        "Tamoxifen 20mg"
      ],
      "description": "Given orally (PO)",
      "armGroupLabels": [
        "Palbociclib 100mg and, fulvestrant or tamoxifen",
        "Palbociclib 125mg and, fulvestrant or tamoxifen"
      ]
    }
  },
  {
    "op": "add",
    "path": "/protocolSection/armsInterventionsModule/interventions/2",
    "value": {
      "name": "Fulvestrant",
      "type": "DRUG",
      "otherNames": [
        "Faslodex"
      ],
      "description": "Given by intramuscular (IM) injection.",
      "armGroupLabels": [
        "Palbociclib 100mg and, fulvestrant or tamoxifen",
        "Palbociclib 125mg and, fulvestrant or tamoxifen"
      ]
    }
  },
  {
    "op": "replace",
    "path": "/protocolSection/outcomesModule/primaryOutcomes/0/measure",
    "value": "Percentage of Participants With Grade 3 or 4 Neutropenia"
  },
  {
    "op": "replace",
    "path": "/protocolSection/outcomesModule/secondaryOutcomes/1/measure",
    "value": "Proportion of Participants With Demonstrated Clinical Benefit"
  },
  {
    "op": "replace",
    "path": "/protocolSection/outcomesModule/secondaryOutcomes/1/description",
    "value": "Defined as the proportion of patients whose best overall response, according to RECIST, is either complete response (CR), a partial response (PR) or stable disease (SD) at 24 weeks.\nOnly those patients who have measurable disease present at baseline, have received at least one cycle of therapy, and have had their disease re-evaluated will be considered evaluable for response."
  },
  {
    "op": "replace",
    "path": "/protocolSection/outcomesModule/secondaryOutcomes/1/timeFrame",
    "value": "24 weeks"
  },
  {
    "op": "replace",
    "path": "/protocolSection/outcomesModule/secondaryOutcomes/2/measure",
    "value": "Proportion of Participants With an Objective Response"
  },
  {
    "op": "replace",
    "path": "/protocolSection/outcomesModule/secondaryOutcomes/2/description",
    "value": "Defined as the proportion of patients whose best overall response, according to RECIST, is either complete response (CR), a partial response (PR) at 24 weeks.\nOnly those patients who have measurable disease present at baseline, have received at least one cycle of therapy, and have had their disease re-evaluated will be considered evaluable for response."
  },
  {
    "op": "replace",
    "path": "/protocolSection/outcomesModule/secondaryOutcomes/2/timeFrame",
    "value": "24 weeks"
  },
  {
    "op": "add",
    "path": "/protocolSection/outcomesModule/secondaryOutcomes/3",
    "value": {
      "measure": "Median Change in Percent Positive Cells From Baseline of Ki-67",
      "timeFrame": "Up to 24 months",
      "description": "Median change in percent positive cells of Ki-67 from baseline will be reported with IQR"
    }
  },
  {
    "op": "add",
    "path": "/protocolSection/outcomesModule/secondaryOutcomes/4",
    "value": {
      "measure": "Median Change in Percent Positive Cells From Baseline of Total-Rb",
      "timeFrame": "Up to 24 months",
      "description": "Median change in percent positive cells of Total-Rb from baseline will be reported with interquartile range (IQR)"
    }
  },
  {
    "op": "add",
    "path": "/protocolSection/outcomesModule/secondaryOutcomes/5",
    "value": {
      "measure": "Median Change in Percent Positive Cells From Baseline of pS780-Rb",
      "timeFrame": "Up to 24 months",
      "description": "Median change in percent positive cells of pS780-Rb from baseline will be reported with IQR"
    }
  },
  {
    "op": "remove",
    "path": "/annotationSection"
  },
  {
    "op": "replace",
    "path": "/hasResults",
    "value": true
  },
  {
    "op": "add",
    "path": "/resultsSection",
    "value": {
      "moreInfoModule": {
        "pointOfContact": {
          "email": "Hope.Rugo@ucsf.edu",
          "phone": "(415) 353-7618",
          "title": "Dr. Hope Rugo, MD",
          "organization": "University of California, San Francisco"
        },
        "certainAgreement": {
          "piSponsorEmployee": true
        }
      },
      "adverseEventsModule": {
        "timeFrame": "Up to 24 months",
        "eventGroups": [
          {
            "id": "EG000",
            "title": "Palbociclib 100mg",
            "description": "Palbociclib dose 100mg and either fulvestrant (500 mg IM on days 1 and 15 in the first 28 days, then every 28 days thereafter) or tamoxifen (20 mg PO daily by physician choice)",
            "otherNumAtRisk": 36,
            "deathsNumAtRisk": 36,
            "otherNumAffected": 7,
            "seriousNumAtRisk": 36,
            "deathsNumAffected": 3,
            "seriousNumAffected": 5
          },
          {
            "id": "EG001",
            "title": "Palbociclib 125mg",
            "description": "Palbociclib dose 125mg and either fulvestrant (500 mg IM on days 1 and 15 in the first 28 days, then every 28 days thereafter) or tamoxifen (20 mg PO daily by physician choice)",
            "otherNumAtRisk": 34,
            "deathsNumAtRisk": 34,
            "otherNumAffected": 9,
            "seriousNumAtRisk": 34,
            "deathsNumAffected": 1,
            "seriousNumAffected": 2
          }
        ],
        "otherEvents": [
          {
            "term": "Neutrophil count decreased",
            "stats": [
              {
                "groupId": "EG000",
                "numAtRisk": 36,
                "numEvents": 12,
                "numAffected": 5
              },
              {
                "groupId": "EG001",
                "numAtRisk": 34,
                "numEvents": 19,
                "numAffected": 9
              }
            ],
            "organSystem": "Investigations",
            "assessmentType": "SYSTEMATIC_ASSESSMENT",
            "sourceVocabulary": "CTCAE (4.0)"
          },
          {
            "term": "Hypertension",
            "stats": [
              {
                "groupId": "EG000",
                "numAtRisk": 36,
                "numEvents": 2,
                "numAffected": 2
              },
              {
                "groupId": "EG001",
                "numAtRisk": 34,
                "numEvents": 0,
                "numAffected": 0
              }
            ],
            "organSystem": "Vascular disorders",
            "assessmentType": "SYSTEMATIC_ASSESSMENT",
            "sourceVocabulary": "CTCAE (4.0)"
          }
        ],
        "seriousEvents": [
          {
            "term": "Gastrointestinal disorders - Other",
            "stats": [
              {
                "groupId": "EG000",
                "numAtRisk": 36,
                "numEvents": 1,
                "numAffected": 1
              },
              {
                "groupId": "EG001",
                "numAtRisk": 34,
                "numEvents": 1,
                "numAffected": 1
              }
            ],
            "organSystem": "Gastrointestinal disorders",
            "assessmentType": "SYSTEMATIC_ASSESSMENT",
            "sourceVocabulary": "CTCAE (4.0)"
          },
          {
            "term": "Infections and infestations - Other",
            "stats": [
              {
                "groupId": "EG000",
                "numAtRisk": 36,
                "numEvents": 1,
                "numAffected": 1
              },
              {
                "groupId": "EG001",
                "numAtRisk": 34,
                "numEvents": 0,
                "numAffected": 0
              }
            ],
            "organSystem": "Infections and infestations",
            "assessmentType": "SYSTEMATIC_ASSESSMENT",
            "sourceVocabulary": "CTCAE (4.0)"
          },
          {
            "term": "Dehydration",
            "stats": [
              {
                "groupId": "EG000",
                "numAtRisk": 36,
                "numEvents": 0,
                "numAffected": 0
              },
              {
                "groupId": "EG001",
                "numAtRisk": 34,
                "numEvents": 1,
                "numAffected": 1
              }
            ],
            "organSystem": "Metabolism and nutrition disorders",
            "assessmentType": "SYSTEMATIC_ASSESSMENT",
            "sourceVocabulary": "CTCAE (4.0)"
          },
          {
            "term": "Pleural effusion",
            "stats": [
              {
                "groupId": "EG000",
                "numAtRisk": 36,
                "numEvents": 2,
                "numAffected": 2
              },
              {
                "groupId": "EG001",
                "numAtRisk": 34,
                "numEvents": 0,
                "numAffected": 0
              }
            ],
            "organSystem": "Respiratory, thoracic and mediastinal disorders",
            "assessmentType": "SYSTEMATIC_ASSESSMENT",
            "sourceVocabulary": "CTCAE (4.0)"
          },
          {
            "term": "Respiratory, thoracic and mediastinal disorders - Other",
            "stats": [
              {
                "groupId": "EG000",
                "numAtRisk": 36,
                "numEvents": 1,
                "numAffected": 1
              },
              {
                "groupId": "EG001",
                "numAtRisk": 34,
                "numEvents": 0,
                "numAffected": 0
              }
            ],
            "organSystem": "Respiratory, thoracic and mediastinal disorders",
            "assessmentType": "SYSTEMATIC_ASSESSMENT",
            "sourceVocabulary": "CTCAE (4.0)"
          }
        ],
        "frequencyThreshold": "5"
      },
      "outcomeMeasuresModule": {
        "outcomeMeasures": [
          {
            "type": "PRIMARY",
            "title": "Percentage of Participants With Grade 3 or 4 Neutropenia",
            "denoms": [
              {
                "units": "Participants",
                "counts": [
                  {
                    "value": "36",
                    "groupId": "OG000"
                  },
                  {
                    "value": "34",
                    "groupId": "OG001"
                  }
                ]
              }
            ],
            "groups": [
              {
                "id": "OG000",
                "title": "Palbociclib 100mg",
                "description": "Palbociclib dose 100mg, and either fulvestrant (500 mg IM on days 1 and 15 in the first 28 days, then every 28 days thereafter) or tamoxifen (20 mg PO daily by physician choice)"
              },
              {
                "id": "OG001",
                "title": "Palbociclib 125mg",
                "description": "Palbociclib dose 125mg and either fulvestrant (500 mg IM on days 1 and 15 in the first 28 days, then every 28 days thereafter) or tamoxifen (20 mg PO daily by physician choice)"
              }
            ],
            "classes": [
              {
                "categories": [
                  {
                    "measurements": [
                      {
                        "value": "19.4",
                        "groupId": "OG000"
                      },
                      {
                        "value": "20.5",
                        "groupId": "OG001"
                      }
                    ]
                  }
                ]
              }
            ],
            "paramType": "NUMBER",
            "timeFrame": "Up to 24 months",
            "description": "Grade 3&#x2F;4 neutropenia as defined by NCI Common Terminology Criteria for Adverse Events (CTCAE) v4.03 in patients with prior exposure to 1-3 lines of chemotherapy for metastatic breast cancer",
            "unitOfMeasure": "percentage of participants",
            "reportingStatus": "POSTED"
          },
          {
            "type": "SECONDARY",
            "title": "Progression-free Survival (PFS)",
            "denoms": [
              {
                "units": "Participants",
                "counts": [
                  {
                    "value": "36",
                    "groupId": "OG000"
                  },
                  {
                    "value": "34",
                    "groupId": "OG001"
                  }
                ]
              }
            ],
            "groups": [
              {
                "id": "OG000",
                "title": "Palbociclib 100mg",
                "description": "Palbociclib dose 100mg, and either fulvestrant (500 mg IM on days 1 and 15 in the first 28 days, then every 28 days thereafter) or tamoxifen (20 mg PO daily by physician choice)"
              },
              {
                "id": "OG001",
                "title": "Palbociclib 125mg",
                "description": "Palbociclib dose 125mg and either fulvestrant (500 mg IM on days 1 and 15 in the first 28 days, then every 28 days thereafter) or tamoxifen (20 mg PO daily by physician choice)"
              }
            ],
            "classes": [
              {
                "categories": [
                  {
                    "measurements": [
                      {
                        "value": "6.53",
                        "groupId": "OG000",
                        "lowerLimit": "2.33",
                        "upperLimit": "12.2"
                      },
                      {
                        "value": "9.4",
                        "groupId": "OG001",
                        "lowerLimit": "3.56",
                        "upperLimit": "19.7"
                      }
                    ]
                  }
                ]
              }
            ],
            "paramType": "MEDIAN",
            "timeFrame": "Up to 24 months",
            "description": "PFS defined as the interval from study entry to the first documented evidence of disease progression by Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 as at least a 20% increase in the sum of the longest diameter (SLD) of target lesions, taking as reference the smallest sum SLD recorded since the treatment started and minimum 5 mm increase over the nadir, or the appearance of one or more new lesions.\nPatients who remain progression-free at the time of analysis will be censored at their last date of follow-up.",
            "unitOfMeasure": "months",
            "dispersionType": "95% Confidence Interval",
            "reportingStatus": "POSTED"
          },
          {
            "type": "SECONDARY",
            "title": "Proportion of Participants With Demonstrated Clinical Benefit",
            "denoms": [
              {
                "units": "Participants",
                "counts": [
                  {
                    "value": "36",
                    "groupId": "OG000"
                  },
                  {
                    "value": "32",
                    "groupId": "OG001"
                  }
                ]
              }
            ],
            "groups": [
              {
                "id": "OG000",
                "title": "Palbociclib 100mg",
                "description": "Palbociclib dose 100mg, and either fulvestrant (500 mg IM on days 1 and 15 in the first 28 days, then every 28 days thereafter) or tamoxifen (20 mg PO daily by physician choice)"
              },
              {
                "id": "OG001",
                "title": "Palbociclib 125mg",
                "description": "Palbociclib dose 125mg and either fulvestrant (500 mg IM on days 1 and 15 in the first 28 days, then every 28 days thereafter) or tamoxifen (20 mg PO daily by physician choice)"
              }
            ],
            "classes": [
              {
                "categories": [
                  {
                    "measurements": [
                      {
                        "value": "0.67",
                        "groupId": "OG000"
                      },
                      {
                        "value": "0.75",
                        "groupId": "OG001"
                      }
                    ]
                  }
                ]
              }
            ],
            "paramType": "NUMBER",
            "timeFrame": "24 weeks",
            "description": "Defined as the proportion of patients whose best overall response, according to RECIST, is either complete response (CR), a partial response (PR) or stable disease (SD) at 24 weeks.\nOnly those patients who have measurable disease present at baseline, have received at least one cycle of therapy, and have had their disease re-evaluated will be considered evaluable for response.",
            "unitOfMeasure": "proportion of participants",
            "reportingStatus": "POSTED",
            "populationDescription": "Two participants in the 125mg group did not have an evaluable disease assessment 24 weeks"
          },
          {
            "type": "SECONDARY",
            "title": "Proportion of Participants With an Objective Response",
            "denoms": [
              {
                "units": "Participants",
                "counts": [
                  {
                    "value": "36",
                    "groupId": "OG000"
                  },
                  {
                    "value": "32",
                    "groupId": "OG001"
                  }
                ]
              }
            ],
            "groups": [
              {
                "id": "OG000",
                "title": "Palbociclib 100mg",
                "description": "Palbociclib dose 100mg, and either fulvestrant (500 mg IM on days 1 and 15 in the first 28 days, then every 28 days thereafter) or tamoxifen (20 mg PO daily by physician choice)"
              },
              {
                "id": "OG001",
                "title": "Palbociclib 125mg",
                "description": "Palbociclib dose 125mg and either fulvestrant (500 mg IM on days 1 and 15 in the first 28 days, then every 28 days thereafter) or tamoxifen (20 mg PO daily by physician choice)"
              }
            ],
            "classes": [
              {
                "categories": [
                  {
                    "measurements": [
                      {
                        "value": "0.1111",
                        "groupId": "OG000"
                      },
                      {
                        "value": "0.0625",
                        "groupId": "OG001"
                      }
                    ]
                  }
                ]
              }
            ],
            "paramType": "NUMBER",
            "timeFrame": "24 weeks",
            "description": "Defined as the proportion of patients whose best overall response, according to RECIST, is either complete response (CR), a partial response (PR) at 24 weeks.\nOnly those patients who have measurable disease present at baseline, have received at least one cycle of therapy, and have had their disease re-evaluated will be considered evaluable for response.",
            "unitOfMeasure": "proportion of participants",
            "reportingStatus": "POSTED",
            "populationDescription": "Two participants in the 125mg group did not have an evaluable disease assessment 24 weeks"
          },
          {
            "type": "SECONDARY",
            "title": "Median Change in Percent Positive Cells From Baseline of Ki-67",
            "denoms": [
              {
                "units": "Participants",
                "counts": [
                  {
                    "value": "36",
                    "groupId": "OG000"
                  },
                  {
                    "value": "34",
                    "groupId": "OG001"
                  }
                ]
              }
            ],
            "groups": [
              {
                "id": "OG000",
                "title": "Palbociclib 100mg",
                "description": "Palbociclib dose 100mg, and either fulvestrant (500 mg IM on days 1 and 15 in the first 28 days, then every 28 days thereafter) or tamoxifen (20 mg PO daily by physician choice)"
              },
              {
                "id": "OG001",
                "title": "Palbociclib 125mg",
                "description": "Palbociclib dose 125mg and either fulvestrant (500 mg IM on days 1 and 15 in the first 28 days, then every 28 days thereafter) or tamoxifen (20 mg PO daily by physician choice)"
              }
            ],
            "classes": [
              {
                "categories": [
                  {
                    "measurements": [
                      {
                        "value": "-8",
                        "groupId": "OG000",
                        "lowerLimit": "-22",
                        "upperLimit": "0"
                      },
                      {
                        "value": "-6",
                        "groupId": "OG001",
                        "lowerLimit": "-19",
                        "upperLimit": "-1"
                      }
                    ]
                  }
                ]
              }
            ],
            "paramType": "MEDIAN",
            "timeFrame": "Up to 24 months",
            "description": "Median change in percent positive cells of Ki-67 from baseline will be reported with IQR",
            "unitOfMeasure": "change in percent positive cells",
            "dispersionType": "Inter-Quartile Range",
            "reportingStatus": "POSTED"
          },
          {
            "type": "SECONDARY",
            "title": "Median Change in Percent Positive Cells From Baseline of Total-Rb",
            "denoms": [
              {
                "units": "Participants",
                "counts": [
                  {
                    "value": "36",
                    "groupId": "OG000"
                  },
                  {
                    "value": "34",
                    "groupId": "OG001"
                  }
                ]
              }
            ],
            "groups": [
              {
                "id": "OG000",
                "title": "Palbociclib 100mg",
                "description": "Palbociclib dose 100mg, and either fulvestrant (500 mg IM on days 1 and 15 in the first 28 days, then every 28 days thereafter) or tamoxifen (20 mg PO daily by physician choice)"
              },
              {
                "id": "OG001",
                "title": "Palbociclib 125mg",
                "description": "Palbociclib dose 125mg and either fulvestrant (500 mg IM on days 1 and 15 in the first 28 days, then every 28 days thereafter) or tamoxifen (20 mg PO daily by physician choice)"
              }
            ],
            "classes": [
              {
                "categories": [
                  {
                    "measurements": [
                      {
                        "value": "4",
                        "groupId": "OG000",
                        "lowerLimit": "-25",
                        "upperLimit": "30"
                      },
                      {
                        "value": "5",
                        "groupId": "OG001",
                        "lowerLimit": "-15",
                        "upperLimit": "29"
                      }
                    ]
                  }
                ]
              }
            ],
            "paramType": "MEDIAN",
            "timeFrame": "Up to 24 months",
            "description": "Median change in percent positive cells of Total-Rb from baseline will be reported with interquartile range (IQR)",
            "unitOfMeasure": "change in percent positive cells",
            "dispersionType": "Inter-Quartile Range",
            "reportingStatus": "POSTED"
          },
          {
            "type": "SECONDARY",
            "title": "Median Change in Percent Positive Cells From Baseline of pS780-Rb",
            "denoms": [
              {
                "units": "Participants",
                "counts": [
                  {
                    "value": "36",
                    "groupId": "OG000"
                  },
                  {
                    "value": "34",
                    "groupId": "OG001"
                  }
                ]
              }
            ],
            "groups": [
              {
                "id": "OG000",
                "title": "Palbociclib 100mg",
                "description": "Treatment arm palbociclib dose 100mg + fulvestrant or tamoxifen"
              },
              {
                "id": "OG001",
                "title": "Palbociclib 125mg",
                "description": "Palbociclib dose 125mg and either fulvestrant (500 mg IM on days 1 and 15 in the first 28 days, then every 28 days thereafter) or tamoxifen (20 mg PO daily by physician choice)"
              }
            ],
            "classes": [
              {
                "categories": [
                  {
                    "measurements": [
                      {
                        "value": "-3",
                        "groupId": "OG000",
                        "lowerLimit": "-32",
                        "upperLimit": "4"
                      },
                      {
                        "value": "-6",
                        "groupId": "OG001",
                        "lowerLimit": "-14",
                        "upperLimit": "12"
                      }
                    ]
                  }
                ]
              }
            ],
            "paramType": "MEDIAN",
            "timeFrame": "Up to 24 months",
            "description": "Median change in percent positive cells of pS780-Rb from baseline will be reported with IQR",
            "unitOfMeasure": "change in percent positive cells",
            "dispersionType": "Inter-Quartile Range",
            "reportingStatus": "POSTED"
          }
        ]
      },
      "participantFlowModule": {
        "groups": [
          {
            "id": "FG000",
            "title": "Palbociclib 100mg",
            "description": "Palbociclib dose 100mg, and either fulvestrant (500 mg intramuscular injection (IM) on days 1 and 15 in the first 28 days, then every 28 days thereafter) or tamoxifen (20 mg PO daily by physician choice)"
          },
          {
            "id": "FG001",
            "title": "Palbociclib 125mg",
            "description": "Palbociclib dose 125mg and either fulvestrant (500 mg IM on days 1 and 15 in the first 28 days, then every 28 days thereafter) or tamoxifen (20 mg PO daily by physician choice)"
          }
        ],
        "periods": [
          {
            "title": "Overall Study",
            "milestones": [
              {
                "type": "STARTED",
                "achievements": [
                  {
                    "groupId": "FG000",
                    "numSubjects": "36"
                  },
                  {
                    "groupId": "FG001",
                    "numSubjects": "34"
                  }
                ]
              },
              {
                "type": "COMPLETED",
                "achievements": [
                  {
                    "groupId": "FG000",
                    "numSubjects": "36"
                  },
                  {
                    "groupId": "FG001",
                    "numSubjects": "34"
                  }
                ]
              },
              {
                "type": "NOT COMPLETED",
                "achievements": [
                  {
                    "groupId": "FG000",
                    "numSubjects": "0"
                  },
                  {
                    "groupId": "FG001",
                    "numSubjects": "0"
                  }
                ]
              }
            ]
          }
        ]
      },
      "baselineCharacteristicsModule": {
        "denoms": [
          {
            "units": "Participants",
            "counts": [
              {
                "value": "36",
                "groupId": "BG000"
              },
              {
                "value": "34",
                "groupId": "BG001"
              },
              {
                "value": "70",
                "groupId": "BG002"
              }
            ]
          }
        ],
        "groups": [
          {
            "id": "BG000",
            "title": "Palbociclib 100mg",
            "description": "Palbociclib dose 100mg, and either fulvestrant (500 mg IM on days 1 and 15 in the first 28 days, then every 28 days thereafter) or tamoxifen (20 mg PO daily by physician choice)"
          },
          {
            "id": "BG001",
            "title": "Palbociclib 125mg",
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