Status:
COMPLETED
Predicting Response to Capecitabine in Women With Metastatic Breast Cancer
Lead Sponsor:
Centre Antoine Lacassagne
Conditions:
Breast Cancer
Eligibility:
FEMALE
18+ years
Phase:
NA
Brief Summary
RATIONALE: Identifying genes that increase a person's susceptibility to side effects caused by capecitabine may help doctors plan better treatment. PURPOSE: This clinical trial is studying blood samp...
Detailed Description
OBJECTIVES: Primary * To determine the sensitivity, specificity, and positive and negative predictive values of dihydrouracil/uracil (UH\_2/U) ratio measured before starting treatment on grade 3-4 c...
Eligibility Criteria
Inclusion
- DISEASE CHARACTERISTICS:
- Radiologically (by scintography) or histologically confirmed metastatic breast cancer
- At least 1 measurable or evaluable target lesion
- Receiving capecitabine as monotherapy or with targeted antiangiogenic therapies (e.g., bevacizumab or trastuzumab)
- No uncontrolled brain metastases
- Hormone receptor status not specified
- PATIENT CHARACTERISTICS:
- Menopausal status not specified
- Life expectancy ≥ 3 months
- Fertile patients must use effective contraception
- No chronic uncontrolled illness
- No congestive heart failure
- No peripheral venous disease
- No severe uncontrolled infection
- No hypoxemic respiratory failure
- No prior primary cancer except for basal cell carcinoma of the skin
- No psychologic disorder
- PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
- No capecitabine co-administered with chemotherapy
Exclusion
Key Trial Info
Start Date :
January 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2011
Estimated Enrollment :
303 Patients enrolled
Trial Details
Trial ID
NCT00953537
Start Date
January 1 2009
End Date
February 1 2011
Last Update
February 10 2015
Active Locations (1)
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1
Centre Antoine Lacassagne
Nice, France, 06189