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8 Continuous vs 8 Intermittent Cycles in First and Second Line Treatment of Patients With HER2/Neu Negative, Incurable, Metastatic or Unresectable Locally Advanced Breast Cancer. (Stop&Go)
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.
Details
| Lead sponsor | Borstkanker Onderzoek Groep |
|---|---|
| Phase | Phase 3 |
| Status | COMPLETED |
| Enrolment | 420 |
| Start date | 2010-11 |
| Completion | 2019-04-01 |
Conditions
- Human Epidermal Growth Factor 2 Negative Carcinoma of Breast
- Metastatic Breast Cancer
Interventions
- Paclitaxel, Bevacizumab, liposomal doxorubicin, Capecitabine
- Paclitaxel, Bevacizumab, liposomal doxorubicin, Capecitabine
Primary outcomes
- Progression free survival — 1 year
PFS is defined as the time from start of treatment to the documented progression that requires the patient to switch to the next treatment line or to death due to any cause.
Countries
Netherlands