Status:
COMPLETED
Genetic Expression and Prediction of Response to Neoadjuvant Docetaxel or Doxorubicin in Locally Advanced Breast Cancer
Lead Sponsor:
Hospital San Carlos, Madrid
Collaborating Sponsors:
UNC Lineberger Comprehensive Cancer Center
Conditions:
Breast Cancer
Eligibility:
FEMALE
18-75 years
Phase:
PHASE2
Brief Summary
After a core biopsy of the tumor is obtained, patients with locally advanced breast cancer are randomized to receive 4 cycles of full dose doxorubicin (75 mg/m2 e3w) or docetaxel (100 mg/m2 e3w). Afte...
Detailed Description
The aim of the study is to define the genetic signature which predicts the response to single drug doxorubicin versus docetaxel. 250 patients will be included. cDNA microarrays will be produced and th...
Eligibility Criteria
Inclusion
- Locally advanced, inoperable breast carcinoma or stage II not amenable to breast preserving surgery (amendment introduced on november 2006)
- Signed informed consent
Exclusion
- Age \>75
- Cardiac disease; LEFT \<50%
- Hyperbilirubinemia
Key Trial Info
Start Date :
January 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 1 2009
Estimated Enrollment :
250 Patients enrolled
Trial Details
Trial ID
NCT00123929
Start Date
January 1 2005
End Date
May 1 2009
Last Update
August 6 2009
Active Locations (1)
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1
Servicio de Oncologia Medica, Hospital Clinico San Carlos
Madrid, Spain, 28040