Modifications of Hormone Receptors and Biological Parameters of Metastatic Breast Cancer Treated With First-line Chemotherapy. Prospective Biological Study.
18 Years
N/A
Female
Breast Cancer
Trial Information
Modifications of Hormone Receptors and Biological Parameters of Metastatic Breast Cancer Treated With First-line Chemotherapy. Prospective Biological Study.
OBJECTIVES:
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.
Inclusion Criteria
DISEASE CHARACTERISTICS:
- 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
Type of Study:
Interventional
Study Design:
Primary Purpose: Treatment
Outcome Measure:
Changes in hormone receptor expression
Safety Issue:
No
Principal Investigator
Philippe Chollet, MD, PhD
Investigator Affiliation:
Centre Jean Perrin
Authority:
United States: Federal Government
Study ID:
CDR0000626717
NCT ID:
NCT00870168
Start Date:
January 2006
Completion Date:
Related Keywords:
- Breast Cancer
- stage IV breast cancer
- estrogen receptor-negative breast cancer
- progesterone receptor-negative breast cancer
- Breast Neoplasms
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