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Benefit of Adding Trastuzumab to Second Line Chemotherapy in Breast Cancer Patients Previously Treated With Trastuzumab

NCT00130507 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 14

Last updated 2019-02-26

No results posted yet for this study

Summary

Eligible patients must receive vinorelbine plus capecitabine, with or without trastuzumab, until disease progression or unbearable toxicity. Cycles will be administered every 3 weeks.Human epidermal growth factor receptor 2 (HER2) status must be locally assessed by immunohistochemistry (IHC). All 3+ patients are eligible. In 2+ patients, HER2 status must be confirmed by fluorescence in situ hybridization (FISH).

Conditions

Interventions

DRUG

Vinorelbine

DRUG

Capecitabine

DRUG

Trastuzumab

Sponsors & Collaborators

  • Hoffmann-La Roche

    collaborator INDUSTRY

  • Spanish Breast Cancer Research Group

    lead OTHER

Principal Investigators

  • Study Director · Hospital Clinic i Provincial

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2005-11-04
Primary Completion
2009-06-30
Completion
2009-07-25

Countries

  • Spain

Study Locations

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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 NCT00130507 on ClinicalTrials.gov