Doxorubicin Hydrochloride and Cyclophosphamide Followed by Paclitaxel With or Without Carboplatin in Treating Patients With Triple-Negative Breast Cancer
Recruiting | Phase III
A Randomized Phase III Trial of Adjuvant Therapy Comparing Doxorubicin Plus Cyclophosphamide Followed by Weekly Paclitaxel with or without Carboplatin for Node-Positive or High-Risk Node-Negative Triple-Negative Invasive Breast Cancer
To compare the good and bad effects of the chemotherapy drug, carboplatin, given with the usual chemotherapy drugs after surgery, compared to the usual chemotherapy drugs given without carboplatin.
- Study agents: Doxorubicin, Cyclophosphamide, Paclitaxel, Carboplatin
- Lab Biomarker Analysis
- Quality of Life questionnaires
- ARM A: Doxorubicin + Cyclophosphamide x 4 cycles, followed by Paclitaxel
- ARM B: Doxorubicin + Cyclophosphamide x 4 cycles, followed by Paclitaxel + Carboplatin
After completion of study therapy, patients are followed for at least 10 years.
Key Participation Requirements:
Male or Female
19 years and older
Breast cancer that has higher risk features (i.e. – positive lymph nodes and/or large size)
Marker Status: Triple Negative (ER, PR, and Her-2 Negative)
Patients must have undergone a lumpectomy or mastectomy.
Patients cannot have had any prior chemotherapy.
Patients must sign an approved informed consent and authorization permitting release of personal health information.
Methodist Health System Trial Code:
For more information, visit the U.S. National Library of Medicine clinical trial database.