|Title||NSABP B-39/RTOG0413 - 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|
|Description||The primary objective of this study is to determine whether partial breast irradiation (PBI) limited to the region of the tumor bed following lumpectomy provides equivalent local tumor control in the breast compared to conventional whole breast irradiation (WBI) in the local management of early stage breast cancer.
- Women greater than 18 years old.
- The patient must consent to be in the study and must have signed an approved consent form conforming with federal and institutional guidelines.
- The patient should have a life expectancy of at least 10 years, excluding her diagnosis of breast cancer.
- The patient must have stage 0, I, or II breast cancer.
- On histological exam, the tumor must be DCIS or invasive adenocarcinoma of the breast.
- Surgical treatment of the breast must have been lumpectomy, with free margins.
- Gross disease must be unifocal with pathologic tumor size 3cm or less.
- Patients with invasive breast cancer are required to have axillary staging which can include sentinel node biopsy alone, sentinel node biopsy followed by axillary dissection or sampling with a minimum total of 6 axillary nodes, or axillary dissection alone.
- The patient must be randomized within 42 days following the last surgery for breast cancer.
- Patients must have an estrogen receptor (ER) analysis performed on the primary tumor prior to randomization.
- The target lumpectomy cavity must be clearly delineated and the target lumpectomy cavity/whole breast reference volume must be < 30% based on the postoperative/pre-randomization CT scan.
- Patients are eligible if, based on the postoperative/pre-randomization CT scan, PBI is judged to be technically deliverable by a technique for which the radiation oncology facility has been credentialed.
- At the time of randomization, patients must have had an H&P within 4 months and a bilateral mammogram within 6 months.
- Patients with a history of non-breast malignancies are eligible if they have been disesae-free for 5 or more years prior to randomization and are deemed by their physicians to be at low risk.
- T2, T3, stage III, or stage IV breast cancer.
- More than 3 histologically positive axillary nodes.
- Axillary nodes with definite evidence of microscopic or macroscopic extracapsular extension.
- One or more positive non-axillary sentinel node(s).
- Palpable or radiographically suspicious ipsilateral or contralateral axillary, supraclavicular, infraclavicular, or internal mammary nodes, unless there is histologic confirmation that these nodes are negative for tumor.
- Suspicious microcalcifications, densities, or palpable abnormalities unless biopsied and found to be benign.
- Non-epithelial breast malignancies such as sarcoma or lymphoma.
- Proven multicentric carcinoma in more than one quadrant or separated by 4 or more centimeters.
- Paget's disease of the nipple.
- Synchronous bilateral invasive or non-invasive breast cancer.
- History of invasive breast cancer or DCIS.
- Surgical margins that cannot be microscopically assessed or are positive at pathologic evaluation.
- Clear delineation of the extent of the target lumpectomy cavity not possible.
- Treatment plan that includes regional node irradiation.
- Any treatment with radiation therapy, chemotherapy, biotherapy, and/or hormonal therapy administered for the currently diagnosed breast cancer prior to randomization.
- Current therapy with any hormonal agents such as Raloxifene, Tamoxifen, or other selective estrogen receptor modulators, either for osteoporosis or breast cancer prevention.
- Breast implants.
- Prior breast or thoracic RT for any condition.
- Collagen vascular disease, specifically dermatomyositis with a CPK level above normal or with an active skin rash, systemic lupus erythematosis, or scleroderma.
- Pregnancy or lactation at the time of proposed randomization.
- Psychiatric or addictive disorders or other conditions that, in the opinion of the investigator, would preclude the patient from meeting the study requirements.
|Contact Name||Nancy N. and J.C. Lewis Cancer & Research Pavilion|