Trastuzumab in Treating Women With Metastatic Breast Cancer

Not Applicable

Completed

• Conditions: Breast Cancer
• Interventions: Biological: trastuzumab; Other: laboratory biomarker analysis; Other: pharmacological study

• Registration Number: NCT00896376
• Lead Sponsor: Centre Antoine Lacassagne

Brief Summary

RATIONALE: Studying samples of blood in the laboratory from patients with cancer may help doctors learn more about changes that occur in DNA and identify biomarkers related to cancer. It may also help doctors predict how patients will respond to treatment.

PURPOSE: This clinical trial is studying the side effects of trastuzumab in treating women with metastatic breast cancer.

Detailed Description

OBJECTIVES:

Primary

* To evaluate the predictive value of genetic factors on the toxicity and efficacy of a trastuzumab-based therapy in women with metastatic breast cancer.

Secondary

* To analyze tumor factors potentially related to the efficacy of trastuzumab (i.e., expression of proteins involved in cell proliferation and survival).

OUTLINE: This is a multicenter study.

Patients receive standard treatment with trastuzumab. Blood is collected periodically for pharmacogenetic analysis.

Study Timeline

• Study Start: 2005-12
• Study First Submitted: 2009-05-08
• Study First Submitted QC: 2009-05-08
• Study First Posted: 2009-05-11
• Primary Completion: 2009-12
• Study Completion: 2010-09
• Status Verified: 2015-02
• Last Update Submitted: 2015-02-08
• Last Update Posted: 2015-02-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 49

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
trastuzumab	trastuzumab	-
trastuzumab	laboratory biomarker analysis	-
trastuzumab	pharmacological study	-

Primary Outcome Measures

Name	Time	Method
Toxicity, including cardiotoxicity and immuno-allergic reactions	1 year
Clinical response as assessed by RECIST criteria	1 year

Trial Locations

Locations (1)

Centre Antoine Lacassagne; 🇫🇷 Nice, France