Trastuzumab in Treating Women With Metastatic Breast Cancer

Study Overview
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Brief Summary
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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
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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.

Official Title
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Prospective Multicenter Study of Genetic Factors Predictive of the Pharmacodynamics of Trastuzumab in Patients With Metastatic Breast Cancer

Conditions
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Breast Cancer

Intervention / Treatment
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* Biological: trastuzumab
* Other: laboratory biomarker analysis
* Other: pharmacological study


Participation Criteria
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Eligibility Criteria
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DISEASE CHARACTERISTICS: Histologically confirmed breast cancer Metastatic disease, defined by the existence of a secondary tumor localization radiologically (i.e., by radiography, CT scan, MRI scan, or ultrasound) or scintigraphically confrimed Evaluable disease Beginning first-line metastatic treatment with trastuzumab (Herceptin®) with or without chemotherapy Primary tumor must overexpress HER2 (IHC 3+ OR IHC 2+ and FISH+ OR FISH+) Hormone receptor status not specified No brain metastasis PATIENT CHARACTERISTICS: Menopausal status not specified Life expectancy > 3 months Able to undergo cardiotoxicity evaluation every 4 months by measuring LVEF via an isotopic method or ultrasound with systematic registration No chronic uncontrolled disease No heart failure No respiratory failure or hypoxemia No history of another primary cancer except for basal cell carcinoma of the skin No severe uncontrolled infection No psychological incapacity PRIOR CONCURRENT THERAPY: See Disease Characteristics

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: trastuzumab<br> | Biological: trastuzumab<br> <br> Other: laboratory biomarker analysis<br> <br> Other: pharmacological study<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Toxicity, including cardiotoxicity and immuno-allergic reactions |  | 1 year | 
| Clinical response as assessed by RECIST criteria |  | 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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stage IV breast cancer, HER2-positive breast cancer