Status:
COMPLETED
Trastuzumab in Treating Women With Metastatic Breast Cancer
Lead Sponsor:
Centre Antoine Lacassagne
Conditions:
Breast Cancer
Eligibility:
FEMALE
18+ years
Phase:
NA
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...
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...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
December 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2010
Estimated Enrollment :
49 Patients enrolled
Trial Details
Trial ID
NCT00896376
Start Date
December 1 2005
End Date
September 1 2010
Last Update
February 10 2015
Active Locations (1)
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1
Centre Antoine Lacassagne
Nice, France, 06189