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Clinical Trials/EUCTR2005-000403-33-ES
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.

Registry
who.int
Start Date
May 16, 2006
End Date
TBD
Last Updated
14 years ago
Study Type
Interventional clinical trial of medicinal product
Sex
Female

Investigators

Sponsor
GRUPO ESPAÑOL DE INVESTIGACIÓN EN CÁNCER DE MAMA (GEICAM)

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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