| Trial Name: |
NSABP B-39
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| Intro: |
A Randomized Phase III Study of Conventional Whole Breast Irradiation (WBI) Versus Partial Breast Irradiation (PBI) for Women with Stage 0, I or II Breast Cancer |
| Condition: |
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| Description: |
A Randomized Phase III Study of Conventional Whole Breast Irradiation (WBI) Versus Partial Breast Irradiation (PBI) for Women with Stage 0, I or II Breast Cancer.
This study is being conducted to evaluate whether partial breast irradiation (PBI) is as effective as whole breast irradiation (WBI) in keeping cancer from coming back to the breast following lumpectomy for early stage breast cancer. A random selection process will determine whether patients will be placed into Group 1 to receive WBI, or Group 2 to receive PBI. Patients in both groups may receive chemotherapy and hormonal therapy if their doctors decide it is necessary. Patients in Group 1 will start WBI soon after joining the study if there is no need for chemotherapy. If chemotherapy is needed, it will be given before radiation. After the chemotherapy is finished, WBI will be given once a day for 5 days a week over 5 to 7 weeks. Patients in Group 2 will start PBI soon after joining the study. The treatments will be given 2 times a day, about 6 hours apart, for 5 days. The treatments may be given over a period of 5 to 10 days. If chemotherapy is needed, it will start after the PBI treatment is finished. Both Group 1 and 2 will receive at least 5 years of hormonal therapy if an individual patient’s breast cancer is affected by hormones (estrogen or progesterone). If chemotherapy is needed, the hormonal therapy will begin after chemotherapy has ended. If chemotherapy is not needed, hormonal therapy can begin before, during, or after the radiation therapy. |
| Criteria: |
- Stage 0 (DCIS) or stage I or II invasive adenocarcinoma of the breast with no evidence of metastatic disease. If stage II, tumor size must be 3 cm or less Undergone a lumpectomy with the margins of the resected specimen histologically-free of cancer including DCIS Axillary staging which can include sentinel node biopsy alone (if sentinel node is negative), sentinel node biopsy followed by axillary dissection or sampling with a minimum total of 6 axillary nodes (for invasive cancer) Axillary nodes restricted to those with 0 to 3 positive axillary nodes
- Life expectancy of at least ten years, excluding diagnosis of breast cancer
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| Contact: |
For Cancer Information, Current Clinical Trials, and Referral to a Physician please call (216) 844-5432 or (800) 641-2422 |
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All information regarding participation in Clinical Trials is treated with the
utmost confidentiality. University Hospitals Case Medical Center and the
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participants is restricted to authorized clinical trials personnel only.
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