NCT01556243

Breast-Conserving Surgery and Radiation Therapy in Patients With Multiple Ipsilateral Breast Cancer

Version 14 to 15 · Alliance for Clinical Trials in Oncology

Patch inspector

Version 14 to 15

364 operations 6 path groups ctgov_internal_history

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_changecontact_admin_changeeligibility_criteria_change

Value signals

[
  {
    "path": "/protocolSection/statusModule/primaryCompletionDateStruct/date",
    "signal": "timeline_major_slip",
    "category": "timeline_major_slip",
    "new_type": "ESTIMATED",
    "old_type": "ESTIMATED",
    "severity": "medium",
    "direction": "later",
    "new_value": "2020-07",
    "old_value": "2014-07",
    "delta_days": 2192,
    "date_struct": "primaryCompletionDateStruct",
    "new_precision": "month",
    "old_precision": "month"
  }
]

Provenance

Source: ctgov_internal_history
Fetched: 2026-06-18 18:59:31+00
Raw hash: c7a8d78c971a8f417bc272cbabe2a003d3c895b9d00ceedb13ef5e51ce2aca73
Payload: Source URL

Design Trial model, phase, allocation, masking, arms, or interventions. Triage: High 1 ops

replace /protocolSection/armsInterventionsModule/armGroups/0/description

Triage: High

Arm Intervention Change Operation 8

Matched rules

arms_or_interventions_change Arms or interventions changes can alter treatment/comparator structure.

Before

Patients undergo breast conserving surgery with all lesions resected to negative margins using one lumpectomy or 2-3 separate lumpectomy incisions at the discretion of the surgeon.
Patients receive adjuvant chemotherapy and&#x2F;or endocrine therapy at the discretion of the treating medical oncologist based on tumor characteristics.
Within 6-10 weeks after surgery or 8 weeks after completion of cytotoxic chemotherapy, patients undergo adjuvant whole breast irradiation with a boost to the lumpectomy bed of each site of disease 5 days per week for approximately 6 weeks.

After

Patients undergo breast conserving surgery.
Patients receive adjuvant chemotherapy at the physician&#x27;s discretion.
Patients receiving chemotherapy will start treatment within 12 weeks following surgery.
Patients receive radiation therapy within 8 weeks following the last dose of chemotherapy or within 10 weeks following surgery if not receiving chemotherapy.
Patients receive endocrine therapy at the physician&#x27;s discretion.
Patient observation will occur every 6 months until 5 years after the end of radiation therapy.

Eligibility Criteria and population definition changes. Triage: High 1 ops

replace /protocolSection/eligibilityModule/eligibilityCriteria

Triage: High

Eligibility Change Operation 9

Matched rules

eligibility_criteria_change Eligibility criteria changes can alter the studied population.

Before

<p>Registration Inclusion Criteria:</p><ol><li>Age ≥ 40 years per National Comprehensive Cancer Network (NCCN) recommendations for breast conservation.</li><li>Life Expectancy of at least 5 years, excluding diagnosis of breast cancer (Comorbid conditions should be taken into consideration, but breast cancer diagnosis is not a consideration)</li><li><p>Female Gender - Men are excluded from this study.
Male breast cancer is a rare event.</p><p>Men are rarely candidates for breast conservation surgery due to small breast size.
Men are less likely to be candidates for breast conservation surgery if found to have MIBC.</p></li><li><p>Foci of Breast Cancer - Upon clinical exam and pre-operative imaging by both MRI and mammogram, two or three foci of biopsy proven breast cancer separated by &gt; 2 cm of normal breast tissue.
Foci must include at least one focus of invasive breast carcinoma with another focus of either invasive breast carcinoma or ductal carcinoma in situ (DCIS).</p><p>No more than 2 quadrants with biopsy proven breast cancer.</p><p>Note: Patient is eligible for study if lesion is not visualized on both imaging modalities (i.e., any of the lesion(s) is&#x2F;are visualized on MRI but not on mammogram OR visualized on mammogram but not on MRI).
Ultrasound cannot be used to determine patient eligibility; eligibility to be determined by bilateral mammogram and MRI only.
Patient may remain on study if, upon pathological assessment, two or three lesions identified on pre-operative imaging represent one contiguous lesion.</p></li><li>Mammogram Imaging - Bilateral mammogram ≤ 60 days prior to registration</li><li>MRI Imaging - Bilateral breast MRI ≤ 60 days prior to registration</li><li>Staging of Cancer - cN0 or cN1 disease</li><li><p>ECOG Performance Status (PS) - 0, 1, or 2.</p><p>Note: An ECOG PS scale is available on the Cancer Trial Support Unit (CTSU) website.</p></li><li><p>Hemoglobin and Platelet Count - The following laboratory values obtained ≤ 21 days prior to registration:</p><ul><li>Hemoglobin (Hgb) ≥ 8 g&#x2F;dL</li><li>Peripheral platelet count (PLT) ≥ 50,000&#x2F;mm3</li></ul></li><li>Pregnancy for Women of Childbearing Potential - Negative urine or serum pregnancy test result ≤ 7 days prior to registration for women of childbearing potential only.</li><li>Ability to Complete Questionnaires by themselves or with assistance.</li><li>Ability to Provide Written Informed Consent</li><li>Willing to return to enrolling institution for follow-up during the Active Monitoring Phase (the active treatment and observation portions) of the study.
Patients are encouraged to return to the enrolling institution; however, patients may receive radiation therapy at a different institution other than the enrolling institution.</li></ol><p>Registration Exclusion Criteria:</p><ol><li><p>Pregnancy, Nursing and Requirement for Contraception Any of the following because this study involves radiation therapy (WBI) that has known genotoxic, mutagenic and teratogenic effects:</p><ul><li>Pregnant women</li><li>Nursing women</li><li>Women of childbearing potential who are unwilling to employ adequate contraception (as determined by the treating physician)</li></ul></li><li>Size of Single Focus of Disease - Largest single focus of disease &gt; 5 centimeters by either mammogram or MRI or both.
Note: Measurement of the largest single focus should include any satellite lesions within 1centimeter of the index lesion.</li><li><p>Prior Staging Procedure - Surgical axillary staging procedure prior to study entry.</p><p>Note: FNA or core needle biopsy of axillary node is permitted.</p></li><li>Evidence of Metastatic Disease - Clinical or radiographic evidence of metastatic disease</li><li>Prior history of ipsilateral breast cancer [DCIS, LCIS (lobular cancer in situ) or invasive]</li><li>Staging of Cancer - cNX, cN2, or cN3 disease</li><li><p>Breast Implants at time of diagnosis.</p><p>Note: Patients who have had implants previously removed prior to diagnosis are eligible.</p></li><li>Systemic Illnesses or Concurrent Disease - Co-morbid systemic illnesses or other severe concurrent disease which, in the judgment of the investigator, would interfere significantly with whole breast irradiation (such as connective tissue disorders, lupus, scleroderma).</li><li>Uncontrolled Intercurrent Illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness&#x2F;social situations that would limit compliance with study requirements.</li><li>Bilateral Breast Cancer Prior or current LCIS, DCIS or invasive breast cancer in the opposite breast (i.e., bilateral disease is not allowed).</li><li>Disallowed Prior Treatments - Treatment including radiation therapy, chemotherapy, biotherapy, hormonal therapy for this cancer prior to registration.</li><li>Chemotherapy or Endocrine Therapy Prior to Surgery - Neoadjuvant chemotherapy or neoadjuvant endocrine therapy (in other words, no chemotherapy or endocrine therapy prior to surgery) for this cancer.</li><li>Partial Breast Radiation - Planned partial breast radiation.</li><li>Investigational Agents - Administration of any investigational agent ≤ 30 days prior to registration.</li><li>Known BRCA Mutations - Patients with known BRCA mutations.</li><li>Other Active Malignancies - Other active malignancy ≤ 5 years prior to registration.</li></ol><p>Exceptions: Non-melanotic skin cancer or carcinoma-in-situ of the cervix.
Note: If there is a history of prior malignancy, they must not be receiving other specific treatment for their cancer.</p>

After

<p>Registration Inclusion Criteria:</p><ol><li>Age ≥ 40 years per National Comprehensive Cancer Network (NCCN) recommendations for breast conservation.</li><li>Life Expectancy of at least 5 years, excluding diagnosis of breast cancer (Comorbid conditions should be taken into consideration, but breast cancer diagnosis is not a consideration)</li><li><p>Female Gender - Men are excluded from this study.
Male breast cancer is a rare event.</p><p>Men are rarely candidates for breast conservation surgery due to small breast size.
Men are less likely to be candidates for breast conservation surgery if found to have MIBC.</p><p>Men are rarely candidates for breast conservation surgery due to small breast size.
Men are less likely to be candidates for breast conservation surgery if found to have MIBC.</p></li><li><p>Foci of Breast Cancer</p><p>4.1 Upon clinical exam and pre-operative imaging by mammogram +&#x2F;- MRI, two or three foci of biopsy proven breast cancer separated by &gt; 2 cm of normal breast tissue.</p><p>4.2 Foci must include at least one focus of invasive breast carcinoma with another focus of either invasive breast carcinoma or ductal carcinoma in situ (DCIS).</p><p>No more than 2 quadrants with biopsy proven breast cancer.</p><p>4.3 Note: The shortest distance between lesions must be reported on mammogram +&#x2F;- MRI and eligibility criteria must be met on both, if both are obtained.</p><p>4.4 Note: Patient is eligible for study if lesion is not visualized on all imaging modalities (i.e., any of the lesion(s) is&#x2F;are visualized on MRI but not on mammogram OR visualized on mammogram but not on MRI).</p><p>4.5 Ultrasound cannot be used to determine patient eligibility; eligibility to be determined by bilateral mammogram +&#x2F;- MRI only.</p><p>4.6 Fine needle aspirate of the second or third lesion to document malignancy is allowed if the first focus is shown to be invasive by core needle biopsy.</p><p>4.7 Patient may remain on study if, upon pathological assessment, two or three lesions identified on pre-operative imaging represent one contiguous lesion.</p></li><li><p>Patients may be registered AFTER surgery and PRIOR TO radiation therapy if either of the criteria is met:</p><p>5.1 An area of atypia &gt; 2cm from the index lesion excised at the time of cancer operation is upgraded to DCIS or invasive carcinoma thereby identifying MIBC.
OR</p><p>5.2 Patient underwent resection of two or three foci of malignancy by breast conservation surgery with a minimum of one invasive focus of breast cancer and a minimum of 2 cm of normal breast tissue between the lesions on final pathology.</p></li><li><p>Mammogram Imaging - Bilateral mammogram ≤ 90 days prior to date of surgery.</p><p>6.1 Note: For patients undergoing more than 1 breast operation, this is the date of the first breast surgery for breast cancer treatment.</p></li><li>Staging of Cancer - cN0 or cN1 disease</li><li>ECOG Performance Status (PS) - 0, 1, or 2.</li><li>Ability to Complete Questionnaires - Ability to complete questionnaire(s) by themselves or with assistance</li><li>Ability to Provide Written Informed Consent</li><li>Willing to Return to Enrolling Institution - Willing to return to enrolling institution for follow-up during the Active Monitoring Phase (the active treatment and observation portions) of the study.
Patients are encouraged to return to the enrolling institution; however, patients may receive radiation therapy at a different institution other than the enrolling institution.</li></ol><p>Registration Exclusion Criteria:</p><ol><li><p>Pregnancy, Nursing and Requirement for Contraception - Pregnant women, nursing women and women of childbearing potential who are unwilling to employ adequate contraception (as determined by the treating physician) are excluded from participation.</p><p>This study involves radiation therapy (WBI) that has known genotoxic, mutagenic and teratogenic effects.</p></li><li>Size of Single Focus of Disease on Preoperative Imaging - Largest single focus of disease &gt; 5 centimeters by either mammogram or MRI or both.
Note: Measurement of the largest single focus should include any satellite lesions within 1 centimeter of the index lesion.</li><li>Prior Staging Procedure - Surgical axillary staging procedure prior to first definitive breast operation.
Note: FNA or core needle biopsy of axillary node is permitted.</li><li>Evidence of Metastatic Disease - Clinical or radiographic evidence of metastatic disease</li><li>Prior History of Breast Cancer - Prior history of ipsilateral breast cancer [DCIS, LCIS (lobular cancer in situ) or invasive]</li><li>Staging of Cancer - cNX, cN2, or cN3 disease</li><li>Breast Implants - Breast implants at time of diagnosis.
Note: Patients who have had implants previously removed prior to diagnosis are eligible.</li><li>Systemic Illnesses or Concurrent Disease - Co-morbid systemic illnesses or other severe concurrent disease which, in the judgment of the investigator, would interfere significantly with whole breast irradiation (such as connective tissue disorders, lupus, scleroderma).</li><li>Uncontrolled Intercurrent Illness - Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness&#x2F;social situations that would limit compliance with study requirements.</li><li>Bilateral Breast Cancer - Prior or current LCIS, DCIS or invasive breast cancer in the opposite breast (i.e., bilateral disease is not allowed).</li><li>Disallowed Prior Treatments - Treatment including radiation therapy, chemotherapy, biotherapy, hormonal therapy for this cancer prior to surgery (i.e., any neoadjuvant chemotherapy or endocrine therapy is not allowed).
Patients who undergo surgical resection with breast conservation and then are treated with adjuvant systemic therapy are eligible to enroll prior to the start of radiotherapy.</li><li>Partial Breast Radiation - Planned partial breast radiation.</li><li>Known BRCA Mutations - Patients with known BRCA mutations.
Patients who are not tested or whose testing result is not returned at the time of registration are not excluded from registering to this study.</li><li>Other Active Malignancies - Other active malignancy ≤ 5 years prior to registration.</li></ol><p>14.1 Exceptions: Non-melanotic skin cancer or carcinoma-in-situ of the cervix.</p><p>14.2 Note: If there is a history of prior malignancy, they must not be receiving other specific treatment for their cancer.</p>

Timeline Start, primary completion, and completion date movement. Triage: Medium 1 ops

replace /protocolSection/statusModule/primaryCompletionDateStruct/date

Triage: Medium

Timeline Shift Operation 4

Matched rules

primary_completion_timeline_change Primary completion date changes are operational timeline signals.

Before

2014-07

After

2020-07

Contacts and locations Site, contact, and location updates that are usually operational. Triage: Low 355 ops

replace /protocolSection/contactsLocationsModule/locations/0/facility

Triage: Uncategorized

Uncategorized Operation 10

Before

East Bay Radiation Oncology Center

After

Bay Area Breast Surgeons, Incorporated

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Triage: Uncategorized

Uncategorized Operation 11

Before

Castro Valley

After

Emeryville

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Triage: Uncategorized

Uncategorized Operation 12

Before

After

replace /protocolSection/contactsLocationsModule/locations/0/geoPoint/lat

Triage: Uncategorized

Uncategorized Operation 13

Before

37.6941

After

37.83132

replace /protocolSection/contactsLocationsModule/locations/0/geoPoint/lon

Triage: Uncategorized

Uncategorized Operation 14

Before

-122.08635

After

-122.28525

remove /protocolSection/contactsLocationsModule/locations/4

Triage: Uncategorized

Uncategorized Operation 15

Before

{
  "zip": "94040",
  "city": "Mountain View",
  "state": "California",
  "status": "RECRUITING",
  "country": "United States",
  "contacts": [
    {
      "name": "Clinical Trials Office - El Camino Hospital Cancer Center",
      "role": "CONTACT",
      "phone": "650-988-7623"
    }
  ],
  "facility": "El Camino Hospital Cancer Center",
  "geoPoint": {
    "lat": 37.38605,
    "lon": -122.08385
  }
}

replace /protocolSection/contactsLocationsModule/locations/5/facility

Triage: Uncategorized

Uncategorized Operation 16

Before

Bay Area Breast Surgeons, Incorporated

After

Bay Area Tumor Institute