Trastuzumab in Treating Women With Metastatic Breast Cancer
NCT ID: NCT00896376
Last Updated: 2015-02-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
49 participants
INTERVENTIONAL
2005-12-31
2010-09-30
Brief Summary
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PURPOSE: This clinical trial is studying the side effects of trastuzumab in treating women with metastatic breast cancer.
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Detailed Description
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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.
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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trastuzumab
trastuzumab
laboratory biomarker analysis
pharmacological study
Interventions
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trastuzumab
laboratory biomarker analysis
pharmacological study
Eligibility Criteria
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Inclusion Criteria
* 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
18 Years
FEMALE
No
Sponsors
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Centre Antoine Lacassagne
OTHER
Responsible Party
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Principal Investigators
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Jean Marc Ferrero, MD
Role: STUDY_CHAIR
Centre Antoine Lacassagne
Locations
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Centre Antoine Lacassagne
Nice, , France
Countries
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Other Identifiers
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CALACASS-2005/35
Identifier Type: -
Identifier Source: secondary_id
CALACASS-PHRC 2005 Herceptine
Identifier Type: -
Identifier Source: secondary_id
INCA-RECF0618
Identifier Type: -
Identifier Source: secondary_id
CDR0000626782
Identifier Type: -
Identifier Source: org_study_id
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