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

Phase 2

Withdrawn

• 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

• Registration Number: NCT01100489
• Lead Sponsor: Case Comprehensive Cancer Center

Brief 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.

Study Timeline

• Study Start: 2010-02
• Study First Submitted: 2010-04-07
• Study First Submitted QC: 2010-04-07
• Study First Posted: 2010-04-09
• Primary Completion: 2011-10
• Study Completion: 2011-10
• Status Verified: 2011-12
• Last Update Submitted: 2011-12-07
• Last Update Posted: 2011-12-08

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Ipsilateral breast tumor recurrence rates	5 years after completion of radiation	Ipsilateral breast 6 months after diagnosis, bilateral annually for 5 years
To determine the cosmetic outcome resulting from breast conserving surgery and breast radiation	at 1 year after radiation

Secondary Outcome Measures

Name	Time	Method
To determine if there are patient factors which limit a patient's suitability to receive breast conserving therapy	5 years after completion of radiation treatment
Patient satisfaction with the procedure as determined by a questionnaire	at 1 year after radiation
To evaluate wound healing and overall complication rate after radiation	at one year after radiation

Trial Locations

Locations (3)

Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center; 🇺🇸 Cleveland, Ohio, United States

UH-Chagrin Highlands; 🇺🇸 Orange Village, Ohio, United States

UH-Westlake; 🇺🇸 Westlake, Ohio, United States