TBP Study With Capecitabine Plus Minus Trastuzumab

Breast Cancer Clinical Trial

Official title: A Multicenter Randomized Phase III Study to Compare Capecitabine Alone or in Combination With Trastuzumab in Patients With HER2 Positive Metastatic Breast Cancer and Progression After Previous Treatment With Trastuzumab

Status Completed

Clinical Trial Summary

This study is done in patients having Breast Cancer with metastasis (patients with positive receptor HER2) whose disease progressed after receiving Trastuzumab.

The primary objective of this study is to compare the time until disease progression between the Treatment Arm CAPECITABINE and the Treatment Arm CAPECITABINE + TRASTUZUMAB

The study has also other secondary and tertiary objectives.

Clinical Trial Description

Trial design:

Prospective, multi-center, controlled, non blinded, randomized phase III Study

Treatment:

Patients with HER2 positive metastatic breast cancer and progression after previous treatment with trastuzumab are being randomized to either:

A. Capecitabine 2500 mg/m² orally day 1-14 q day 22 until progression * and discontinuation of Trastuzumab

B. Capecitabine and Trastuzumab:

Capecitabine 2500 mg/m² orally day 1-14 q day 22 until progression * Trastuzumab 6 mg/kg body weight every 3 weeks i.v. as a 90 min infusion until progression *

Objectives:

Primary objective:

To compare the time to disease progression in patients with HER2 positive metastatic breast cancer and progression after previous treatment with trastuzumab randomized to capecitabine alone or in combination with trastuzumab.

Secondary objectives:

To compare the objective response rate between the two arms To compare the duration of response To compare the clinical benefit defined as CR, PR, or stable disease > 24 weeks between the two arms To evaluate the safety of the capecitabine + trastuzumab combination To compare overall survival between the two arms

Tertiary objective:

To determine the HER2 status in tissue collected directly before study entry ;

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

• NCT number: NCT00148876
• Study type: Interventional
• Source: German Breast Group
• Status: Completed
• Phase: Phase 3
• Start date: September 2003
• Completion date: January 2011