TBP Study With Capecitabine Plus Minus Trastuzumab
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00148876|
Recruitment Status : Completed
First Posted : September 8, 2005
Last Update Posted : February 23, 2011
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.
|Condition or disease||Intervention/treatment||Phase|
|Breast Cancer||Drug: Capecitabine Drug: Trastuzumab||Phase 3|
Prospective, multi-center, controlled, non blinded, randomized phase III Study
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 *
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.
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
To determine the HER2 status in tissue collected directly before study entry
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||482 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
|Study Start Date :||September 2003|
|Primary Completion Date :||January 2011|
|Study Completion Date :||January 2011|
Active Comparator: Capecitabine
Capecitabine 2500 mg/m² orally day 1-14 q day 22 until progression and discontinuation of Trastuzumab.
Capecitabine 2500 mg/m² orally day 1-14 q day 22
Experimental: 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
Capecitabine 2500 mg/m² orally day 1-14 q day 22Drug: Trastuzumab
Trastuzumab 6 mg/kg body weight every 3 weeks i.v.
- Any progression of disease or disease related death of a patient
- Any response documented according to the RECIST Criteria
- Time from CR or PR until progression of disease or death due to any cause
- Any response and stable disease of >24 weeks duration documented according to the RECIST Criteria
- Any grade III/IV toxicity (NCI-CTC version2.0).Premature treatment discontinuation
- Any death of a patient
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00148876
|Johann Wolfgang Goethe Universität, Universitätsfrauenklinik|
|Frankfurt / Main, Hessen, Germany, 60590|
|Principal Investigator:||Gunter von Minckwitz, Prof. Dr.||German Breast Group Forschungs GmbH|