Impact of Breast Conservation Surgery on Surgical Outcomes and Cosmesis in Patients With Multiple Ipsilateral Breast Cancers (MIBC)
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Breast Cancer
- Sponsor
- Alliance for Clinical Trials in Oncology
- Enrollment
- 270
- Locations
- 350
- Primary Endpoint
- Local Recurrence
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
RATIONALE: Breast-conserving surgery is a less invasive type of surgery for breast cancer and may have fewer side effects and improve recovery. Radiation therapy uses high-energy x rays to kill tumor cells. Giving radiation therapy after surgery may kill any tumor cells that remain after surgery.
PURPOSE: This phase II trial studies how well breast-conserving surgery and radiation therapy work in treating patients with multiple ipsilateral breast cancer
Detailed Description
OBJECTIVES: Primary * To assess the local recurrence (LR) rate with breast-conservation in patients with multiple ipsilateral primary breast cancer (MIBC). Secondary * To examine the conversion rate to mastectomy secondary to persistent positive margins; poor cosmesis within the first year of attempting breast-conservation surgery (BCS) or inability to satisfy the radiation dose constraints on the boost to the lumpectomy bed of each site of disease. * To assess whether patients who did not undergo re-excision for close margins (\< 2 mm) have a higher local recurrence (LR) rate than patients for whom negative margins were achieved. * To assess patient's perception of cosmesis and incidence of breast lymphedema. * To assess incidence of breast lymphedema * To examine the type and severity of adverse effects of breast conserving surgery and radiation for women with multiple ipsilateral primary breast cancer (MIBC). * To examine the radiation-related side effects of whole-breast radiation with a boost to 1 large or \> 1 lumpectomy site. OUTLINE: This is a multicenter study. Patients undergo breast-conserving surgery (BCS) with all lesions resected to negative margins using 1 lumpectomy or 2-3 separate lumpectomy incisions at the discretion of the surgeon. Patients receive adjuvant chemotherapy and/or endocrine therapy at the discretion of the treating medical oncologist based on tumor characteristics.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Age ≥ 40 years per National Comprehensive Cancer Network (NCCN) recommendations for breast conservation.
- •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)
- •Female Gender - Men are excluded from this study. Male breast cancer is a rare event.
- •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.
- •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.
- •Foci of Breast Cancer
- •4.1 Upon clinical exam and pre-operative imaging by mammogram +/- MRI, two or three foci of biopsy proven breast cancer separated by \> 2 cm of normal breast tissue.
- •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).
- •No more than 2 quadrants with biopsy proven breast cancer.
- •4.3 Note: The shortest distance between lesions must be reported on mammogram +/- MRI and eligibility criteria must be met on both, if both are obtained.
Exclusion Criteria
- •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.
- •This study involves radiation therapy (WBI) that has known genotoxic, mutagenic and teratogenic effects.
- •Size of Single Focus of Disease on Preoperative Imaging - Largest single focus of disease \> 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.
- •Prior Staging Procedure - Surgical axillary staging procedure prior to first definitive breast operation. Note: FNA or core needle biopsy of axillary node is permitted.
- •Evidence of Metastatic Disease - Clinical or radiographic evidence of metastatic disease
- •Prior History of Breast Cancer - Prior history of ipsilateral breast cancer \[DCIS, LCIS (lobular cancer in situ) or invasive\]
- •Staging of Cancer - cNX, cN2, or cN3 disease
- •Breast Implants - Breast implants at time of diagnosis. Note: Patients who have had implants previously removed prior to diagnosis are eligible.
- •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).
- •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/social situations that would limit compliance with study requirements.
Outcomes
Primary Outcomes
Local Recurrence
Time Frame: 5 years
Local recurrence(LR) defined as histologic evidence of ductal carcinoma in situ or invasive breast cancer in the ipsilateral breast or chest wall assessed up to 5 years. The estimated 5-year cumulative incidence of LR will be reported as a percentage of patients expected to experience a LR at 5 years.
Secondary Outcomes
- Type and Severity of Adverse Effects of Breast-conserving Surgery and Radiation as Assessed by the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0(Up to 30 days post-treatment)
- Radiation-related Side Effects(17 months)
- Conversion Rate to Mastectomy(5 years)
- Patient's Perception of Cosmesis(24 months)