NCT01556243

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

Impact of Breast Conservation Surgery on Surgical Outcomes and Cosmesis in Patients With Multiple Ipsilateral Breast Cancers (MIBC)

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 270 (actual)
• Sponsor: Alliance for Clinical Trials in Oncology · Academic / Other
• Sex: Female
• Age: 40 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Breast Cancer

Interventions

Type	Name	Description
PROCEDURE	therapeutic conventional surgery
RADIATION	whole breast irradiation

Timeline

• Start date: 2012-07-01
• Primary completion: 2022-06-01
• Completion: 2023-04-15
• First posted: 2012-03-16
• Last updated: 2023-11-30
• Results posted: 2023-11-30

Locations

350 sites across 1 country: United States