This phase II trial studies how well docetaxel and carboplatin work in treating participants with estrogen receptor negative and HER2 negative breast cancer. Drugs used in chemotherapy, such as docetaxel and carboplatin, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT02547987.
PRIMARY OBJECTIVES:
I. To determine whether neoadjuvant docetaxel and carboplatin will increase the pathological complete response (pCR) rate in triple negative breast cancer (TNBC) compared to historical controls.
SECONDARY OBJECTIVES:
I. To determine the xenografting rate from TNBC patients being treated with neoadjuvant chemotherapy.
II. To compare chemotherapy responses in patient-derived xenograft (PDX) and TNBC patients being treated with neoadjuvant chemotherapy.
III. To investigate genomic and proteomic molecular changes in PDX and corresponding host patients with the intent to identify predictors of drug response and resistance.
OUTLINE:
Participants receive docetaxel intravenously (IV) and carboplatin IV on day 1. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Within 4-6 weeks, participants undergo surgery.
After completion of study treatment, participants are followed up at 2 months and then annually for up to 5 years.
Lead OrganizationBaylor College of Medicine/Dan L Duncan Comprehensive Cancer Center
Principal InvestigatorMothaffar Fahed Rimawi