Breast-Conserving Surgery and Radiation Therapy in Patients With Multiple Ipsilateral Breast Cancer
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
Genetic: gene expression analysis
Genetic: protein expression analysis
Other: laboratory biomarker analysis
Other: questionnaire administration
Procedure: adjuvant therapy
Procedure: quality-of-life assessment
Procedure: therapeutic conventional surgery
Radiation: whole breast irradiation
|Study Design:||Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Impact of Breast Conservation Surgery on Surgical Outcomes and Cosmesis in Patients With Multiple Ipsilateral Breast Cancers (MIBC)|
- Local recurrence 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 [ Designated as safety issue: No ]
- Conversion rate to mastectomy secondary to persistent positive margins assessed for up to 1 year [ Designated as safety issue: No ]
- 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 [ Designated as safety issue: Yes ]
- Radiation-related side effects of whole-breast radiation with a boost to 1 large or > 1 lumpectomy site as assessed by NCI CTCAE version 4.0 [ Designated as safety issue: Yes ]
- Patient's perception of cosmesis assessed up to 24 months after WBI using the BREAST-Q© scoring module [ Designated as safety issue: No ]
|Study Start Date:||July 2012|
|Estimated Primary Completion Date:||July 2014 (Final data collection date for primary outcome measure)|
- To assess the local recurrence (LR) rate with breast-conservation in patients with multiple ipsilateral primary breast cancer (MIBC).
- 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 patient's perception of cosmesis and incidence of breast lymphedema.
- To examine the type and severity of adverse effects of BCS and radiation for women with MIBC.
- To examine the radiation-related side effects of whole-breast radiation with a boost to 1 large or > 1 lumpectomy site.
- To evaluate protein and gene expression patterns in tissue taken from each breast lesion and to evaluate the concordance of the findings between these lesions.
- To compare the extent of disease described on imaging (mammography, bilateral breast magnetic resonance imaging [MRI] and other adjunctive imaging modalities) with surgical findings.
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.
Within 6-10 weeks after surgery or 8 weeks after completion of cytotoxic chemotherapy, patients undergo adjuvant whole-breast irradiation (WBI) with a boost to the lumpectomy bed of each site of disease 5 days a week for approximately 6 weeks.
Patients complete the Breast-Conserving Therapy Module (BREAST-Q© subscales) questionnaire 5-30 days after surgery and every 6 months for the first 2 years and the yearly for the next 3 years after WBI. Patients' surgeons also complete the questionnaire 5-30 days after performing final surgery to assess cosmetic outcomes.
Formalin-fixed paraffin-embedded (FFPE) tissue block from each site of disease are collected during BCS for protein and gene expression pattern studies. Blood samples may be also collected at baseline and during BCS.
After completion of study treatment, patients are followed up every 6 months for 2 years and then yearly for years 3-5.