This phase II trial studies how well docetaxel and carboplatin before surgery works in treating patients with stage II-III triple-negative breast cancer that has not previously been treated. 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. Giving docetaxel and carboplatin before surgery may help increase the number of patients with no evidence of cancer left after their treatment.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT02124902.
PRIMARY OBJECTIVE:
I. To determine whether neoadjuvant docetaxel and carboplatin will increase the pathologic complete response (pCR) rate in triple-negative breast cancer (TNBC) compared to historical controls.
EXPLORATORY OBJECTIVES:
I. To determine the xenografting rate from TNBC patients being treated with neoadjuvant chemotherapy.
II. To compare chemotherapy responses in patient-derived xenografts (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.
IV. To assess the utility of multi-parametric fludeoxyglucose F-18-positron emission tomography (FDG-PET)/magnetic resonance (MR) imaging in predicting response to therapy after one cycle of therapy.
V. Measure circulating tumor deoxyribonucleic acid (DNA) (ctDNA) somatic mutations in serial plasma samples, and determine if ctDNA can predict clinical outcomes.
OUTLINE:
Patients receive docetaxel intravenously (IV) over 60 minutes and carboplatin IV over 30 minutes on day 1. Treatment repeats every 21 days for 6 cycles in the absence of disease progression or unacceptable toxicity. Patients then undergo surgery 3-5 weeks after the conclusion of chemotherapy.
After completion of study treatment, patients are followed up yearly for 5 years.
Lead OrganizationSiteman Cancer Center at Washington University
Principal InvestigatorFoluso Olabisi Ademuyiwa