Last updated on November 2017

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


Brief description of study

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

Detailed Study Description

You are being asked to take part in this research study because you have a type of breast cancer that is HER2-negative and is not sensitive to hormone treatment. You have already been treated with surgery. People who are not in a study usually have chemotherapy after surgery, and if needed, radiation therapy. For patients who receive the usual approach for this cancer, about 70 out of 100 are free of cancer at five years.

The purpose of this study is 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. The addition of carboplatin to the usual chemotherapy could prevent your cancer from returning, but it could also cause side effects. This study will allow the researchers to know whether giving carboplatin with the usual chemotherapy is better, the same, or worse than giving the usual chemotherapy. If giving carboplatin with the usual chemotherapy drugs is better, there should be a higher chance that your breast cancer will not return. Carboplatin is FDA-approved for the treatment of cancer and is used for the treatment of breast cancer that has spread, but it has not yet been proven useful in earlier stages of breast cancer.

Clinical Study Identifier: TX8002

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Pamela Treas

Baptist Health Clinical Research Center & Lexington Cardiac Research Foundation
Lexington, KY USA
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