EUCTR2005-000403-33-ES
Active, not recruiting
Not Applicable
Randomized clinical trial to evaluate the predictive accuracy of a geneexpression profile-based test to select patients for preoperativetaxane/anthracycline chemotherapy for stage I-III breast cancer
GRUPO ESPAÑOL DE INVESTIGACIÓN EN CÁNCER DE MAMA (GEICAM)0 sites210 target enrollmentMay 16, 2006
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- GRUPO ESPAÑOL DE INVESTIGACIÓN EN CÁNCER DE MAMA (GEICAM)
- Enrollment
- 210
- Status
- Active, not recruiting
- Last Updated
- 14 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Inclusion Criteria:
- •\- Patients with histologically confirmed stage I\-III invasive carcinoma of the breast
- •for whom adjuvant chemotherapy is indicated.
- •\- Patients must have intact or measurable residual cancer (by mammogram, ultra
- •sonogram or physical exam) in the breast.
- •\- Histological confirmation of invasive tumor needs to be performed on tissue
- •obtained by either core needle biopsy or by partial surgical excision of the tumor.
- •Routine estrogen, progesterone and HER\-2 receptor determination must be
- •requested on the initial diagnostic specimen.
- •\- Patients with a prior history of breast cancer are eligible.
Exclusion Criteria
- •Patients who have completed lumpectomy, segmental mastectomy or modified
- •radical mastectomy and, therefore no longer have any measurable cancer left in
- •their breast are not eligible.
- •Patients with stage IV, metastatic breast cancers are not eligible.
- •Patients for whom anthracycline or paclitaxel chemotherapies are
- •contraindicated, for example:
- •\- hypersensitivity reactions to any of the medications
- •\- uncompensated congestive heart failure
- •\- myocardial infarction within the past 12 month
- •\- pre\-existing peripheral neuropathy \> grade 2
Outcomes
Primary Outcomes
Not specified
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