Spots Global Cancer Trial Database for Carboplatin and Eribulin Mesylate in Triple Negative Breast Cancer Patients

Study Description

Brief Summary: This phase II trial studies how well giving eribulin mesylate and carboplatin together before surgery works in treating patients with stage I-III triple-negative breast cancer. Drugs used in chemotherapy, such as eribulin mesylate and carboplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving chemotherapy before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed.

Detailed Description: PRIMARY OBJECTIVES: I. To determine the pathologic complete response rate (pCR) at the time of definitive surgery. SECONDARY OBJECTIVES: I. Determination of the clinical response rate, as measured by clinical exam and imaging studies prior to initiation of therapy and prior to surgery. II. Measurement of alpha B-crystalline in tissue obtained before initiation of therapy and at the time of definitive surgery. III. Stem cell markers (cluster of differentiation \[CD\]44+, CD24-, CD133, aldehyde dehydrogenase 1 \[ALDH1\] and evaluation of the NOTCH pathway) in tissue obtained before initiation of therapy and at the time of definitive surgery. IV. Measurement of proliferation markers (Ki67) before and after treatment in tissue obtained before imitation of therapy and at the time of definitive surgery. V. Measurement of beta III tubulin in tissue obtained before initiation of therapy and at the time of definitive surgery. VI. Measurement of Tau in tissue obtained before initiation of therapy and at the time of definitive surgery. VII. Safety evaluation, including following of patients for alopecia and neuropathy. VIII. Epidermal growth factor receptor (EGFR) staining before and after treatment in tissue obtained before initiation of therapy and at the time of definitive surgery. OUTLINE: Patients receive eribulin mesylate intravenously (IV) over 2-5 minutes and carboplatin IV over 30 minutes on day 1. Treatment repeats every 21 days for up to 4 courses in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up every 6 months.

Keywords

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

Contact Details

Useful links and downloads for this trial