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.
- 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.
- concurrent immunotherapy or hormonal therapy;
- anthracyclines as part of previous 1st line chemotherapy or planned 2nd line
- cardiac toxicity during previous 1st line chemotherapy + Herceptin;
- history of other malignancy within last 5 years.
Type of Study:
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Time to disease progression
Outcome Time Frame:
Hungary: National Institute of Pharmacology
- Breast Cancer
- Breast Neoplasms