Studying Biopsy Samples in Women Undergoing First-Line Chemotherapy for Metastatic Breast Cancer
NCT ID: NCT00870168
Last Updated: 2011-05-16
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
60 participants
INTERVENTIONAL
2006-01-31
Brief Summary
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PURPOSE: This clinical trial is studying biopsy samples in women who are receiving first-line chemotherapy for metastatic breast cancer.
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Detailed Description
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Primary
* Evaluate the effect of first-line chemotherapy on expression of hormone receptors and biomarkers in women with metastatic breast cancer.
Secondary
* Assess changes in HER1 and HER2 expression during treatment.
OUTLINE: This is a multicenter study.
Patients receive 6-9 courses of front-line chemotherapy according to the investigator. Patients with estrogen receptor- and/or progesterone receptor-positive disease receive hormone therapy.
Patients undergo biopsy prior to and after completion of chemotherapy for examination of hormone receptors and HER1 and HER2 expression.
After completion of study treatment, patients are followed every 6 months for 5 years.
Conditions
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Study Design
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TREATMENT
Interventions
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chemotherapy
gene expression analysis
laboratory biomarker analysis
breast biopsy
Eligibility Criteria
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Inclusion Criteria
* Histologically confirmed adenocarcinoma of the breast
* Metastatic disease
* No inflammatory breast cancer
* Measurable disease according to RECIST criteria
* Hormone receptor status:
* Estrogen receptor- and/or progesterone receptor-negative by IHC
PATIENT CHARACTERISTICS:
* Menopausal status not specified
* WHO performance status 0-2
* Life expectancy \> 3 months
* ANC \> 1.5 x 10\^9/L
* Platelet count \> 100 x 10\^9/L
* Liver transaminases ≤ 3 times upper limit of normal (ULN)
* Alkaline phosphatase ≤ 3 times ULN
* Bilirubin ≤ 1.5 times ULN
* Creatinine ≤ 2 times ULN
* Not pregnant or nursing
* Fertile patients must use effective contraception
* No allergy to xylocaine
* No heart failure, or kidney, bone marrow, respiratory, or liver insufficiency
PRIOR CONCURRENT THERAPY:
* No prior first-line treatment for metastatic disease
18 Years
FEMALE
No
Sponsors
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Centre Jean Perrin
OTHER
Principal Investigators
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Philippe Chollet, MD, PhD
Role:
Centre Jean Perrin
Locations
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Centre Jean Perrin
Clermont-Ferrand, , France
Countries
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Other Identifiers
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JEANP-AU-613
Identifier Type: -
Identifier Source: secondary_id
INCA-RECF0389
Identifier Type: -
Identifier Source: secondary_id
JEANP-RH Meta Sein
Identifier Type: -
Identifier Source: secondary_id
PFIZER-JEANP-AU-613
Identifier Type: -
Identifier Source: secondary_id
CDR0000626717
Identifier Type: -
Identifier Source: org_study_id
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