NCT01372579

Carboplatin and Eribulin Mesylate in Triple Negative Breast Cancer Patients

Phase II Neoadjuvant Trial With Carboplatin and Eribulin Mesylate in Triple Negative Breast Cancer Patients

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Northwestern University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Estrogen Receptor-negative Breast Cancer
• HER2-negative Breast Cancer
• Male Breast Cancer
• Progesterone Receptor-negative Breast Cancer
• Stage IA Breast Cancer
• Stage IB Breast Cancer
• Stage II Breast Cancer
• Stage IIIA Breast Cancer
• Stage IIIB Breast Cancer
• Stage IIIC Breast Cancer
• Triple-negative Breast Cancer

Interventions

Type	Name	Description
DRUG	eribulin mesylate	Given IV
DRUG	carboplatin	Given IV
PROCEDURE	biopsy	Correlative studies

Timeline

• Start date: 2011-08-01
• Primary completion: 2020-06-01
• Completion: 2021-06-01
• First posted: 2011-06-14
• Last updated: 2019-06-07

Locations

1 site across 1 country: United States