Breast Cancer
Conditions
Keywords
stage IV breast cancer, HER2-positive breast cancer
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.
Interventions
BIOLOGICALtrastuzumab
OTHERlaboratory biomarker analysis
OTHERpharmacological study
Sponsors
Centre Antoine Lacassagne
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Toxicity, including cardiotoxicity and immuno-allergic reactions | 1 year |
| Clinical response as assessed by RECIST criteria | 1 year |
Countries
France
Contacts
STUDY_CHAIRJean Marc Ferrero, MD
Centre Antoine Lacassagne
Outcome results
None listed