Trial Information

Summary: A Randomized Phase III Study of Conventional Whole Breast Irradiation (WBI) vs. Partial Breast Irradiation (PBI) for Women with Stage 0, I, or II Breast Cancer

The Dyson Center for Cancer Care at Vassar Brother Medical Center in conjunction with the National Cancer Institute (NCI) and the National Surgical Adjuvant Breast and Bowel Project (NSABP) is conducting the B-39/RTOG-0413 clinical trial.

This is a randomized Phase III randomized trial to evaluate the effectiveness of partial breast irradiation compared to whole breast irradiation in providing equivalent local tumor control in the breast following surgical excision of the early stage breast cancer.

Breast conserving therapy has become an accepted option in the treatment of most patients with Stage I or II breast cancer. Multiple studies have established the long-term equivalence of this treatment approach compared to mastectomy in disease-free and overall survival. There is currently a large body of mature Phase I and II data that have investigated the replacement of whole breast irradiation.

You may be eligible to participate in this trial if:

• Stage 0, I or II breast cancer. Tumor size must be 3.0 cm or less.
• Diagnosis of Ductal Carcinoma in Situ (DCIS) or invasive adenocarcinoma, if invasive must have axillary staging, which can include sentinel lymph node biopsy, if positive must have axillary sampling.
• Surgical margins from breast lumpectomy must be free of any cancer including DCIS.
• No evidence of metastatic disease
• Randomization to the protocol must be within 42 days of the last breast surgery.

You may be ineligible to participate in this trial if:

• History of prior invasive breast cancer or DCIS.
• Any treatment with radiation therapy, chemotherapy, biotherapy and/or hormonal therapy administered for the currently diagnosed breast cancer.
• Breast implants.
• Current therapy with any hormonal agents such as raloxifene (Evista), tamoxifen, or other selective estrogen receptor modulators (SERMs). May become eligible if these medications are discontinued before randomization.
• Pregnancy or lactation at time of randomization.
• Collagen vascular disease.

If you are interested in this study please feel free to check with the Clinical Research Department at Vassar Brothers Medical Center for additional eligibility/ineligibility criteria.

If you would like to learn more about participating in this study, please send an e-mail message using the form below.