Trastuzumab and Vinorelbine in Advanced Breast Cancer

Breast Cancer Clinical Trial

Official title: A Phase II, Single Arm, Open Label Study to Evaluate the Efficacy and Safety of Trastuzumab and Vinorelbine in Advanced Breast Cancer Patients With Human Epidermal Growth Factor-2 (HER2) Negative Primary Tumors and HER2 Positive Circulating Tumor Cells

Status Terminated

Clinical Trial Summary

The purpose of this research study is to see what effects trastuzumab in combination with vinorelbine has on breast cancer when the participant has circulating tumor cells that are positive for the protein called HER2. Trastuzumab is an FDA approved drug that targets HER2. The drug combination of trastuzumab and vinorelbine is an effective treatment for patients with breast cancers that are positive for HER2. This trial seeks to determine if the combination can also benefit participants whose original breast cancer was HER2 negative but whose circulating tumor cells are HER2 positive.

Clinical Trial Description

OBJECTIVES:

Primary

• To assess the objective response rate (ORR) of trastuzumab and vinorelbine in patients with metastatic breast cancer with HER2 negative primary tumors and HER2 positive circulating tumor cells.

Secondary

• To describe the number of CTCs and the CTCs characteristics before and after therapy, and to explore the correlation of these findings with response.

• To further characterize the safety and tolerability.

• To evaluate progression-free survival.

• To evaluate clinical benefit rate [complete response (CR)+partial response (PR)+stable disease (SD)>24 weeks].

Exploratory

• To determine the clinical feasibility of high-throughput mutation profiling on circulating tumor cells (CTCs). ;

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms
• Metastatic Breast Cancer

• NCT number: NCT01185509
• Study type: Interventional
• Source: Dana-Farber Cancer Institute
• Status: Terminated
• Phase: Phase 2
• Start date: November 2010
• Completion date: January 2018