NCT00148876

TBP Study With Capecitabine Plus Minus Trastuzumab

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
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 482 (estimated)
• Sponsor: GBG Forschungs GmbH · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed 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

Conditions

• Breast Cancer

Interventions

Type	Name	Description
DRUG	Capecitabine	Capecitabine 2500 mg/m² orally day 1-14 q day 22
DRUG	Trastuzumab	Trastuzumab 6 mg/kg body weight every 3 weeks i.v.

Timeline

• Start date: 2003-09-01
• Primary completion: 2011-01-01
• Completion: 2011-01-01
• First posted: 2005-09-08
• Last updated: 2011-02-23

Locations

1 site across 1 country: Germany