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A Clinical Trial of Adjuvant Therapy Comparing 6-cycles of 5-FU, Epirubicin, & Cyclophosphamide (FEC) to 4-cycles of Adriamycin & Cyclophosphamide (AC), in patients with node-negative breast cancer (NSABP B-36):
- Diagnosis of T1-3, node negative breast cancer
- Patient must have had a lumpectomy or mastectomy with an axillary node biopsy. Sentinel node biopsy if possible.
A Phase III Trial of Continuous Schedule AC + G vs q.2wk schedule AC, followed by Paclitaxel given either every 2wks or weekly for 12wks as post-op adjuvant therapy in node + or high-risk node negative breast cancer (SO221):
- Stage I, II, or III node positive or high-risk node negative breast cancer with known ER/PR status
- High risk tumor that is greater than 2cm
A Randomized Clinical Trial of Adjuvant Chemotherapy for Radically Resected Loco-Regional Relapse of Breast Cancer (NSABP B-37):
- Pathologically confirmed first local and/or regional recurrence of invasive breast cancer following primary treatment with mastectomy or breast conserving treatment
- No evidence of distant metastasis
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 (RTOG 0413):
- Must have Stage 0, I or II breast cancer. If patient is Stage II, tumor must be less than 3cm
- Surgical treatment must be a lumpectomy
- Patients with invasive breast cancer are required to have axillary staging and no more than 3 nodes positive
- Patients who are 50 years or older with DCIS are not eligible regardless of HER-2 status
- Patients with invasive breast cancer who are 50 years or older, node negative, and HER-2 positive are not eligible
Program for the Assessment of Clinical Cancer Tests; Trial Assigning Individualized Options for Treatment: The TAILORx Trial. (ECOG PACCT-1):
- Newly diagnosed with early-stage (I or II) breast cancer
- Tumor is estrogen and/or progesterone receptor positive, is HER2 receptor negative, and measures 1.1 to 5 cm
- Uses a modern diagnostic test (Oncotype DX) that gives a Recurrence Score that indicates chance of Breast Cancer recurrence
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