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NCT01471106

Phase II Short-term Adjuvant Therapy and Biomarker Studies With Targeted Agents in Women With Estrogen Receptor Negative Breast Cancer

Version 9 to 10 · M.D. Anderson Cancer Center

Patch inspector

Version 9 to 10

12 operations 2 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

None recorded.

Provenance
Source
ctgov_internal_history
Fetched
2026-06-18 19:11:13+00
Raw hash
76fd94ea19e70f7921ff09d3d4ba9081f0d205daa7d996ee4ecc19c1ea8d7642
Payload
Source URL
Design Trial model, phase, allocation, masking, arms, or interventions. Triage: High 8 ops
replace /protocolSection/armsInterventionsModule/armGroups/0/label
Triage: High
Arm Intervention Change Operation 5
Matched rules
  • arms_or_interventions_change Arms or interventions changes can alter treatment/comparator structure.
Before
Dasatinib
After
Group 1: Dasatinib 40 mg
replace /protocolSection/armsInterventionsModule/armGroups/0/description
Triage: High
Arm Intervention Change Operation 6
Matched rules
  • arms_or_interventions_change Arms or interventions changes can alter treatment/comparator structure.
Before
Participants take no drug, or the study drug dasatinib at a dose of 40, or 80 mg daily for 3 months (+/- 7 days) and at the end of the 3 months (+/- 7 days) will undergo a repeat FNA and blood collection for the same marker analyses.
After
Dasatinib 40 mg by mouth once a day for 3 months (+/- 7 days), At the end of the 3 months (+/- 7 days) participants undergo a repeat FNA and blood collection for the same marker analyses.
replace /protocolSection/armsInterventionsModule/armGroups/1/label
Triage: High
Arm Intervention Change Operation 7
Matched rules
  • arms_or_interventions_change Arms or interventions changes can alter treatment/comparator structure.
Before
No Dasatinib
After
Group 3: No Dasatinib
replace /protocolSection/armsInterventionsModule/armGroups/1/description
Triage: High
Arm Intervention Change Operation 8
Matched rules
  • arms_or_interventions_change Arms or interventions changes can alter treatment/comparator structure.
Before
No treatment control group.
After
No treatment control group.
At the end of the 3 months (+/- 7 days) participants undergo a repeat FNA and blood collection for the same marker analyses.
add /protocolSection/armsInterventionsModule/armGroups/2
Triage: High
Arm Intervention Change Operation 9
Matched rules
  • arms_or_interventions_change Arms or interventions changes can alter treatment/comparator structure.
After
{
  "type": "EXPERIMENTAL",
  "label": "Group 2: Dasatinib 80 mg",
  "description": "Dasatinib 80 mg by mouth once a day for 3 months (+/- 7 days).\nAt the end of the 3 months (+/- 7 days) participants undergo a repeat FNA and blood collection for the same marker analyses.",
  "interventionNames": [
    "Drug: Dasatinib"
  ]
}
replace /protocolSection/armsInterventionsModule/interventions/0/description
Triage: High
Arm Intervention Change Operation 10
Matched rules
  • arms_or_interventions_change Arms or interventions changes can alter treatment/comparator structure.
Before
<p>Group 1: 40 mg by mouth once a day.</p><p>Group 2: 80 mg by mouth once a day.</p><p>Group 3: No drug.</p>
After
<p>Group 1: 40 mg by mouth once a day.</p><p>Group 2: 80 mg by mouth once a day.</p>
replace /protocolSection/armsInterventionsModule/interventions/0/armGroupLabels/0
Triage: High
Arm Intervention Change Operation 11
Matched rules
  • arms_or_interventions_change Arms or interventions changes can alter treatment/comparator structure.
Before
Dasatinib
After
Group 1: Dasatinib 40 mg
add /protocolSection/armsInterventionsModule/interventions/0/armGroupLabels/1
Triage: High
Arm Intervention Change Operation 12
Matched rules
  • arms_or_interventions_change Arms or interventions changes can alter treatment/comparator structure.
After
Group 2: Dasatinib 80 mg
Other registry fields Changes outside the current high-signal rule families. Triage: Uncategorized 4 ops
replace /protocolSection/statusModule/statusVerifiedDate
Triage: Uncategorized
Uncategorized Operation 1
Before
2015-02
After
2015-04
replace /protocolSection/statusModule/lastUpdateSubmitDate
Triage: Uncategorized
Uncategorized Operation 2
Before
2015-02-04
After
2015-04-09
replace /protocolSection/statusModule/lastUpdatePostDateStruct/date
Triage: Uncategorized
Uncategorized Operation 3
Before
2015-02-06
After
2015-04-10
replace /protocolSection/descriptionModule/detailedDescription
Triage: Uncategorized
Uncategorized Operation 4
Before
<p>Study Drug Administration:</p><ul><li>If you are found to be eligible to take part in this study, you will be randomly assigned (as in the flip of a coin) to 1 of 3 study groups:</li><li>If you are in Group 1, you will take dasatinib 40mg once a day by mouth with water.</li><li>If you are in Group 2, you will take dasatinib 80mg once a day by mouth with water.</li><li>If you are in Group 3, you will not receive dasatinib.</li></ul><p>You will be given a study drug diary to complete.
In the diary, you will record when you take the study drug.</p><p>Study Visits:</p><p>At Month 1:</p><ul><li>Blood (about 2 tablespoons) will be drawn for routine tests.</li><li>You will be asked about any drugs you may be taking and side effects you may be having.</li><li>Your drug diary will be reviewed.</li><li>You will have an electrocardiogram (EKG) to check your heart function.f</li></ul><p>At Month 2 you will be called by a nurse and asked about any drugs you are taking and side effects you may be having.
You will also be asked to review your drug diary.
This call will take about 20 minutes</p><p>At Month 3 (or if you leave the study early):</p><ul><li>You will have a fine needle aspirate (FNA) of the breast for biomarker testing.
Biomarkers are found in the blood&#x2F;tissue and may be related to your reaction to the study drug.</li><li>Blood (about 2-3 tablespoons) will be drawn for biomarker testing.</li><li>You will be asked about any drugs you may be taking and side effects you may be having.</li><li>Your drug diary will be reviewed.</li></ul><p>Length of Study:</p><p>You may remain on study for up to 3 months.
You will no longer be able to take the study drug if the disease gets worse, if intolerable side effects occur, or if you are unable to follow study directions.</p><p>This is an investigational study.
Dasatinib is FDA approved and commercially available for the treatment of leukemia.
Its use in breast cancer patients in investigational.</p><p>Up to 66 patients will take part in this multicenter study.
Up to 60 will be enrolled at MD Anderson.</p>
After
<p>Study Drug Administration:</p><p>If you are found to be eligible to take part in this study, you will be randomly assigned (as in the flip of a coin) to 1 of 3 study groups:</p><ul><li>If you are in Group 1, you will take dasatinib 40mg once a day by mouth with water.</li><li>If you are in Group 2, you will take dasatinib 80mg once a day by mouth with water.</li><li>If you are in Group 3, you will not receive dasatinib.</li></ul><p>You will be given a study drug diary to complete.
In the diary, you will record when you take the study drug.</p><p>Study Visits:</p><p>At Month 1:</p><ul><li>Blood (about 2 tablespoons) will be drawn for routine tests.</li><li>You will be asked about any drugs you may be taking and side effects you may be having.</li><li>Your drug diary will be reviewed.</li></ul><p>At Month 2 you will be called by a nurse and asked about any drugs you are taking and side effects you may be having.
You will also be asked to review your drug diary.
This call will take about 20 minutes</p><p>At Month 3 (or if you leave the study early):</p><ul><li>You will have a fine needle aspirate (FNA) of the breast for biomarker testing.
Biomarkers are found in the blood&#x2F;tissue and may be related to your reaction to the study drug.</li><li>Blood (about 2-3 tablespoons) will be drawn for biomarker testing.</li><li>You will be asked about any drugs you may be taking and side effects you may be having.</li><li>Your drug diary will be reviewed.</li></ul><p>Length of Study:</p><p>You may remain on study for up to 3 months.
You will no longer be able to take the study drug if the disease gets worse, if intolerable side effects occur, or if you are unable to follow study directions.</p><p>This is an investigational study.
Dasatinib is FDA approved and commercially available for the treatment of leukemia.
Its use in breast cancer patients in investigational.</p><p>Up to 66 patients will take part in this multicenter study.
Up to 60 will be enrolled at MD Anderson.</p>
Raw JSON Patch 
[
  {
    "op": "replace",
    "path": "/protocolSection/statusModule/statusVerifiedDate",
    "value": "2015-04"
  },
  {
    "op": "replace",
    "path": "/protocolSection/statusModule/lastUpdateSubmitDate",
    "value": "2015-04-09"
  },
  {
    "op": "replace",
    "path": "/protocolSection/statusModule/lastUpdatePostDateStruct/date",
    "value": "2015-04-10"
  },
  {
    "op": "replace",
    "path": "/protocolSection/descriptionModule/detailedDescription",
    "value": "<p>Study Drug Administration:</p><p>If you are found to be eligible to take part in this study, you will be randomly assigned (as in the flip of a coin) to 1 of 3 study groups:</p><ul><li>If you are in Group 1, you will take dasatinib 40mg once a day by mouth with water.</li><li>If you are in Group 2, you will take dasatinib 80mg once a day by mouth with water.</li><li>If you are in Group 3, you will not receive dasatinib.</li></ul><p>You will be given a study drug diary to complete.\nIn the diary, you will record when you take the study drug.</p><p>Study Visits:</p><p>At Month 1:</p><ul><li>Blood (about 2 tablespoons) will be drawn for routine tests.</li><li>You will be asked about any drugs you may be taking and side effects you may be having.</li><li>Your drug diary will be reviewed.</li></ul><p>At Month 2 you will be called by a nurse and asked about any drugs you are taking and side effects you may be having.\nYou will also be asked to review your drug diary.\nThis call will take about 20 minutes</p><p>At Month 3 (or if you leave the study early):</p><ul><li>You will have a fine needle aspirate (FNA) of the breast for biomarker testing.\nBiomarkers are found in the blood&#x2F;tissue and may be related to your reaction to the study drug.</li><li>Blood (about 2-3 tablespoons) will be drawn for biomarker testing.</li><li>You will be asked about any drugs you may be taking and side effects you may be having.</li><li>Your drug diary will be reviewed.</li></ul><p>Length of Study:</p><p>You may remain on study for up to 3 months.\nYou will no longer be able to take the study drug if the disease gets worse, if intolerable side effects occur, or if you are unable to follow study directions.</p><p>This is an investigational study.\nDasatinib is FDA approved and commercially available for the treatment of leukemia.\nIts use in breast cancer patients in investigational.</p><p>Up to 66 patients will take part in this multicenter study.\nUp to 60 will be enrolled at MD Anderson.</p>"
  },
  {
    "op": "replace",
    "path": "/protocolSection/armsInterventionsModule/armGroups/0/label",
    "value": "Group 1: Dasatinib 40 mg"
  },
  {
    "op": "replace",
    "path": "/protocolSection/armsInterventionsModule/armGroups/0/description",
    "value": "Dasatinib 40 mg by mouth once a day for 3 months (+&#x2F;- 7 days), At the end of the 3 months (+&#x2F;- 7 days) participants undergo a repeat FNA and blood collection for the same marker analyses."
  },
  {
    "op": "replace",
    "path": "/protocolSection/armsInterventionsModule/armGroups/1/label",
    "value": "Group 3: No Dasatinib"
  },
  {
    "op": "replace",
    "path": "/protocolSection/armsInterventionsModule/armGroups/1/description",
    "value": "No treatment control group.\nAt the end of the 3 months (+&#x2F;- 7 days) participants undergo a repeat FNA and blood collection for the same marker analyses."
  },
  {
    "op": "add",
    "path": "/protocolSection/armsInterventionsModule/armGroups/2",
    "value": {
      "type": "EXPERIMENTAL",
      "label": "Group 2: Dasatinib 80 mg",
      "description": "Dasatinib 80 mg by mouth once a day for 3 months (+&#x2F;- 7 days).\nAt the end of the 3 months (+&#x2F;- 7 days) participants undergo a repeat FNA and blood collection for the same marker analyses.",
      "interventionNames": [
        "Drug: Dasatinib"
      ]
    }
  },
  {
    "op": "replace",
    "path": "/protocolSection/armsInterventionsModule/interventions/0/description",
    "value": "<p>Group 1: 40 mg by mouth once a day.</p><p>Group 2: 80 mg by mouth once a day.</p>"
  },
  {
    "op": "replace",
    "path": "/protocolSection/armsInterventionsModule/interventions/0/armGroupLabels/0",
    "value": "Group 1: Dasatinib 40 mg"
  },
  {
    "op": "add",
    "path": "/protocolSection/armsInterventionsModule/interventions/0/armGroupLabels/1",
    "value": "Group 2: Dasatinib 80 mg"
  }
]