A Phase III Clinical Trial Comparing the Combination of Docetaxel Plus Cyclophosphamide to Anthracycline-Based Chemotherapy Regimens for Women with Node-Positive or High-Risk Node-Negative, HER2-Negative Breast Cancer
- Patients must have unilateral invasive adenocarcinoma of the breast on histologic exam.
- Tumor sample must be available for submission.
- Tumor must be HER2-negative; if equivocal, patients are eligible if there is no plan to administer HER2-directed therapy.
- Patients must have either a total mastectomy or a lumpectomy; both with margins clear of invasive tumor and DCIS.
- ER analysis must be performed on the primary tumor prior to randomization. If ER-, PgR status must be assessed.
- No clinical or radiologic evidence of metastatic disease.
- No history of ipsilateral invasive cancer or DCIS.
- No previous therapy with anthracyclines or taxanes for any malignancy.
- No chemotherapy administered for the currently diagnosed breast cancer prior to randomization.
- No current endocrine or sex hormonal therapy.
Principal Investigator Name
Jay Andersen, MD
Legacy Oncology Clinical Research
Last Updated: Wednesday, September 18, 2013 01:35:02 PM