Breast-Conserving Surgery Followed by Radiation Therapy With MRI-Detected Stage I or Stage II Breast Cancer

HER2-positive Breast Cancer Clinical Trial

Official title: A Phase II Study of the Feasibility and Efficacy of Breast Conserving Surgery in Patients With MRI Detected Multi-Centric Breast Cancer

Status Withdrawn

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 clinical trial is studying how well breast-conserving surgery followed by radiation therapy works in treating patients with stage I or stage II breast cancer.

Clinical Trial Description

PRIMARY OBJECTIVES:

I. To determine ipsilateral breast tumor recurrence rates as well as tumor bed recurrence rates. Patients will be followed for a period of five years following completion of radiation to determine these rates.

II. To determine the cosmetic outcome resulting from breast conserving surgery and breast radiation.

SECONDARY OBJECTIVES:

I. To determine if there are patient factors which limit a patient's suitability to receive breast conserving therapy in the setting of multi-centric disease.

II. To determine patient satisfaction of breast conserving therapy as it pertains to their overall treatment experience as measured by a questionnaire.

III. To evaluate wound healing and overall complication rate after radiation as a component of breast conserving therapy.

OUTLINE:

Patients undergo breast-conserving surgery consisting of partial mastectomies followed by external beam breast radiation therapy 5 days a week for 5 weeks in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed at 1 month, then every 3 months for 1 year, every 6 months for 1 year, and then annually for 5 years. ;

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Breast Neoplasms
• Breast Neoplasms, Male
• Carcinoma
• Carcinoma in Situ
• Carcinoma, Ductal, Breast
• Carcinoma, Intraductal, Noninfiltrating
• Carcinoma, Lobular
• Ductal Breast Carcinoma in Situ
• Estrogen Receptor-negative Breast Cancer
• Estrogen Receptor-positive Breast Cancer
• HER2-negative Breast Cancer
• HER2-positive Breast Cancer
• Invasive Ductal Breast Carcinoma
• Invasive Lobular Breast Carcinoma
• Male Breast Cancer
• Medullary Ductal Breast Carcinoma With Lymphocytic Infiltrate
• Mucinous Ductal Breast Carcinoma
• Papillary Ductal Breast Carcinoma
• Progesterone Receptor-negative Breast Cancer
• Progesterone Receptor-positive Breast Cancer
• Stage I Breast Cancer
• Stage II Breast Cancer
• Tubular Ductal Breast Carcinoma

• NCT number: NCT01100489
• Study type: Interventional
• Source: Case Comprehensive Cancer Center
• Status: Withdrawn
• Phase: Phase 2
• Start date: February 2010
• Completion date: October 2011