NSABP PROTOCOL B-49:A Phase III Clinical Trial Comparing the Combination of Docetaxel Plus Cyclophosphamide to Anthracycline-Based Chemotherapy Regimens for Women with Node-Positive or High-RiskNode-Negative, HER2-Negative Breast Cancer
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NSABP PROTOCOL B-49:A Phase III Clinical Trial Comparing the Combination of Docetaxel Plus Cyclophosphamide to Anthracycline-Based Chemotherapy Regimens for Women with Node-Positive or High-RiskNode-Negative, HER2-Negative Breast Cancer
Primary Aim: Aim: To determine if the docetaxel plus cyclophosphamide regimen is non-inferior to the anthracycline-based chemotherapy regimens in terms of invasive disease-free survival (IDFS) by combining B-49 data with the TAC and TC arms of NSABP B-46-I/USOR 07132 and the data from USOR 06-090.
Endpoint: IDFS, defined as time to local recurrence following mastectomy, invasive local recurrence in the ipsilateral breast following lumpectomy, regional recurrence, distant recurrence, invasive contralateral breast cancer, second primary cancer (other than squamous or basal cell carcinoma of the skin, melanoma in situ, carcinoma in situ of the cervix, colorectal carcinoma in situ, or lobular carcinoma in situ of the breast), or death from any cause prior to recurrence or second primary cancer.
| Protocol Number | 041203 |
|---|---|
| Principal Investigator | Antoinette Tan |
| Phase | Phase III |
| Scope | National |
| Applicable Disease Sites | Breast - Female |
| Therapies Involved | Chemotherapy (NOS) |
| Drugs Involved | DOCETAXEL DOXORUBICIN CYCLOPHOSPHAMIDE |
| Participating Institutions | Robert Wood Johnson University Hospital at Hamilton The Cancer Institute of New Jersey |
For further information on this clinical trial, please contact us at 732-235-8675 or cinjclinicaltrials@umdnj.edu.
