Impact of Breast Conservation Surgery on Surgical Outcomes and Cosmetic Appearance in Patients with Multiple Tumors in One Breast

Protocol
13-023
Full Title
Z-11102 - Impact of Breast Conservation Surgery on Surgical Outcomes and Cosmesis in Patients with Multiple Ipsilateral Breast Cancers (MIBC)
Purpose

Breast-conserving surgery with lumpectomy (removal of a breast tumor, but not the whole breast) followed by radiation therapy has been shown to be as effective as mastectomy (removal of the entire breast) for women with a single tumor in one breast. Mastectomy has been the traditional surgery for women with more than one tumor in the same breast.

In this study, researchers want to determine if lumpectomy plus radiation therapy is as effective as mastectomy for reducing the risk of cancer recurrence in women with two or three tumors in the same breast, and to assess how satisfied patients and their surgeons are with the cosmetic appearance of the breast. All women in this study will have breast-conserving surgery followed by radiation therapy to the entire affected breast. Investigators will observe how many patients in this study eventually need to return for a mastectomy, and also examine the side effects of whole breast radiation given after lumpectomy.

This study is being conducted by the American College of Surgeons Oncology Group (ACOSOG) through Alliance for Clinical Trials in Oncology (Alliance).

Eligibility

To be eligible for this study, patients must meet several criteria, including but not limited to the following:

  • This study is open to women age 40 and older with two or three tumors in one breast (with each tumor no more than 5 cm in size).
  • At least one tumor in the breast must be invasive breast cancer.
  • Patients may not have previously received treatment for breast cancer.
  • Patients may not have received treatment for any other cancer in the last five years.
  • Patients with metastatic breast cancer may not participate.
  • Patients with a known BRCA mutation may not participate.
  • Patients must be able to be ambulatory for more than half of their normal waking hours.

For more information about this study, please contact Dr. Kimberly Van Zee at 646-888-5241.

Disease(s)
Breast Cancer
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