NCT01100489

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

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

• Status: Withdrawn
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Case Comprehensive Cancer Center · Academic / Other
• Sex: All
• Age: 18 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 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.

Detailed 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.

Conditions

• 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

Interventions

Type	Name	Description
RADIATION	external beam radiation therapy	External beam breast radiation therapy 5 days a week for 5 weeks in the absence of disease progression or unacceptable toxicity.
OTHER	questionnaire administration	Ancillary studies: The patient will complete the Cosmesis /QOL form (Appendix II) and the treating physician will complete the Cosmetic Guidelines (skin assessment) form for baseline data (Appendix I).
PROCEDURE	therapeutic conventional surgery	Patients will undergo excisional biopsy or needle localization removal of the tumor. Patients with margins \< 2 mm undergo re-excision of the biopsy cavity. Surgical clips should be placed at the time of tylectomy to define the excision cavities. Ideally, clips are to be placed marking the superficial, deep, right, left, inferior, and superior dimensions of the tylectomy or re-excision cavities.

Timeline

• Start date: 2010-02-01
• Primary completion: 2011-10-01
• Completion: 2011-10-01
• First posted: 2010-04-09
• Last updated: 2011-12-08

Locations

3 sites across 1 country: United States