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

Breast Cancer Clinical Trial

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

Status Completed

Clinical Trial 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

Clinical Trial 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. ;

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

• NCT number: NCT01556243
• Study type: Interventional
• Source: Alliance for Clinical Trials in Oncology
• Status: Completed
• Phase: Phase 2
• Start date: July 2012
• Completion date: April 15, 2023