A Randomized, Open-label Study to Compare Time to Disease Progression in Patients With HER2 Positive Metastatic Breast Cancer Who Continue or Discontinue Herceptin in Combination With 2nd Line Chemotherapy, Having Progressed on 1st Line Chemotherapy in Combination With Herceptin.
Phase 2
18 Years
N/A
18 Years
N/A
Not Enrolling
Female
Breast Cancer
Female
Breast Cancer
Trial Information
A Randomized, Open-label Study to Compare Time to Disease Progression in Patients With HER2 Positive Metastatic Breast Cancer Who Continue or Discontinue Herceptin in Combination With 2nd Line Chemotherapy, Having Progressed on 1st Line Chemotherapy in Combination With Herceptin.
Inclusion Criteria:
- female patients, >= 18 years of age;
- metastatic breast cancer;
- HER2 overexpression (IHC 3+ and/or FISH positive);
- disease progression during or after previous 1st line chemotherapy + Herceptin;
- scheduled to receive 2nd line chemotherapy.
Exclusion Criteria:
- concurrent immunotherapy or hormonal therapy;
- anthracyclines as part of previous 1st line chemotherapy or planned 2nd line
chemotherapy;
- cardiac toxicity during previous 1st line chemotherapy + Herceptin;
- history of other malignancy within last 5 years.
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Time to disease progression
Outcome Time Frame:
Event driven
Safety Issue:
No
Principal Investigator
Clinical Trials
Investigator Role:
Study Director
Investigator Affiliation:
Hoffmann-La Roche
Authority:
Hungary: National Institute of Pharmacology
Study ID:
ML19944
NCT ID:
NCT00444587
Start Date:
March 2007
Completion Date:
June 2012
Related Keywords:
- Breast Cancer
- Breast Neoplasms
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