drugset / Trial / NCT01935492
8 Continuous vs 8 Intermittent Cycles in First and Second Line in HER2/Neu Neg Metastatic Breast Cancer
Phase 3
Completed
420 enrolled
Dutch Breast Cancer Research Group
Roche Pharma AG · collabTeva Pharma · collab
RandomizedParallel-groupOpen-labelTreatment
Summary
An open randomized phase III study to compare 8 continuous cycles of chemotherapy with 8 cycles of intermittent (2 times 4 cycles) chemotherapy in first line treatment, in combination with bevacizumab, and second line treatment of patients with HER2/neu negative, incurable, metastatic or unresectable locally advanced breast cancer.
Timeline
- Start
- 2010-11
- Primary completion
- 2019-04-01
- Completion
- 2019-04-01
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Bevacizumab | Monoclonal antibody | 10 mg/kg | Intravenous |
| Comparator | Capecitabine | Small molecule | — | — |
| Comparator | Doxorubicin | Other / unclassified | — | — |
| Comparator | Paclitaxel | Small molecule | 90 mg/m2 | Intravenous |