Status:
COMPLETED
Caelyx, Cyclophosphamide and Herceptin in Patients With Metastatic Breast Cancer
Lead Sponsor:
Spanish Breast Cancer Research Group
Collaborating Sponsors:
Schering-Plough
Conditions:
Breast Cancer
Eligibility:
FEMALE
18-75 years
Phase:
PHASE2
Brief Summary
Eligible patients must receive Caelyx plus Cyclophosphamide plus Herceptin for 6 cycles that will be administered every 4 weeks.
Detailed Description
Sample size calculation will be done by means of Simon's method in 2 stages for phase II studies and will be based on the principal aim of the study (evaluation of the rate of objective response). Th...
Eligibility Criteria
Inclusion
- Patients must sign an informed consent before of specific procedures of clinical trial.
- Patients with histologically confirmed breast cancer and overexpression of Her2neu.
- Age\> 18 years.
- Eastern Cooperative Oncology Group (ECOG) equal or \< 2.
- Patients have not been treated previously with chemotherapy for metastatic disease.
- Patients must have at least one measurable lesion according to RECIST criteria.
- Patients should have an adequate organ function to tolerate chemotherapy.
Exclusion
- Patients with hypersensitivity reactions to any of the medications of the clinical trial.
- Patients who are pregnant or lactating are not eligible.
- Hepatic disease.
- Not controlled active infection
- Symptomatic metastatic brain cancer
- Previous adjuvant treatment with anthracyclines with a total accumulated dose \> 300 mg/m2 (Doxorubicin) or \> 600 mg/m2 (Epirubicin)
Key Trial Info
Start Date :
February 15 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 14 2009
Estimated Enrollment :
49 Patients enrolled
Trial Details
Trial ID
NCT00258960
Start Date
February 15 2006
End Date
July 14 2009
Last Update
April 4 2023
Active Locations (12)
Enter a location and click search to find clinical trials sorted by distance.
1
Hospital Germans Trias i Pujol
Badalona, Barcelona, Spain, 08916
2
Fundación Hospital Alcorcón
Alcorcón, Madrid, Spain, 28922
3
Hospital Juan Canalejo
A Coruña, Spain, 15006
4
Centro Oncológico Regional de Galicia
A Coruña, Spain, 15009