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NRG BR003

Doxorubicin Hydrochloride and Cyclophosphamide Followed by Paclitaxel With or Without Carboplatin in Treating Patients With Triple-Negative Breast Cancer

Status:

Recruiting | Phase III

Official Title:

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

Study Purpose:

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.

Interventions:

  • 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:


Gender:

Male or Female

Age:

19 years and older

Diagnosis:

Breast cancer that has higher risk features (i.e. – positive lymph nodes and/or large size)

Eligibility:

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:

NRG BR003

For more information, visit the U.S. National Library of Medicine clinical trial database.

To learn more about this clinical trial please contact us today!