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TBP Study With Capecitabine Plus Minus Trastuzumab

NCT00148876 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 482

Last updated 2011-02-23

No results posted yet for this study

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.

Conditions

Interventions

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.

Sponsors & Collaborators

Principal Investigators

  • Gunter von Minckwitz, Prof. Dr. · German Breast Group Forschungs GmbH

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2003-09-30
Primary Completion
2011-01-31
Completion
2011-01-31

Countries

  • Germany

Study Locations

More Related Trials

Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00148876 on ClinicalTrials.gov