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Lead
Centre Antoine Lacassagne
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.
Age
18–any
Sex
FEMALE
Healthy volunteers
Not accepted
You may be eligible if
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
Clareo Health | Trastuzumab in Treating Women With Metastatic Breast Cancer
