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drugset / Trial / NCT02144194

Maintenance Oral Vinorelbine or Observation After Vinorelbine-Docetaxel First Line Chemotherapy in Advanced Breast Ca

NCT02144194 ↗

Phase 2 Unknown 65 enrolled Cancer Research Group - Collaborative Group, Beirut, Lebanon.
RandomizedParallel-groupOpen-labelTreatment

Summary

This 2 arms study will assess the efficacy and safety of the Vinorelbine-Docetaxel combination given as an initial upfront treatment (first line) to all metastatic breast cancer patients enrolled. Patients having a disease control following initial treatment, will be randomized to either oral Vinorelbine maintenance arm or Observation arm. The trial will also compare the efficacy and safety of maintenance oral Vinorelbine versus Observation.

Timeline

Start
2012-03
Primary completion
2017-06
Completion
2017-12

Drugs

EvaluationDrugModalityDoseRoute
Subject Docetaxel Small molecule 60 mg/m2 —
Subject Vinorelbine Small molecule 20 mg/m2 Intravenous
Subject Vinorelbine Small molecule 60 mg/m2 Intravenous
Subject Vinorelbine Small molecule 80 mg/m2 Intravenous

Indications

breast cancer