Weekly Paclitaxel/Carboplatin/Bevacizumab as First Line Therapy for Triple Negative Breast Cancer

Phase 1/2 Completed 46 enrolled Hellenic Oncology Research Group University Hospital of Crete · collab

NaSingle-groupOpen-labelTreatment

Summary

This study will evaluate the efficacy of weekly paclitaxel-carboplatin combination plus bevacizumab as first line treatment in patients with metastatic triple negative breast cancer. Furthermore, the efficacy of the combination therapy will be correlated with the presence of circulating tumor cells (CTCs) in this population

Timeline

Start: 2008-04
Primary completion: 2016-03
Completion: 2016-03

Outcome

Met primary endpoint

paper CONCLUSION: The study achieved its primary end point by showing clinical activity for weekly paclitaxel with carboplatin and bevacizumab combination. PMID 29153775 ↗

paper Seven (15.2%) complete and 23 (50%) partial responses were observed for an ORR of 65.2% (95% confidence interval, 52.9%-80.4%). PMID 29153775 ↗

Publications

Saloustros E, Nikolaou M, Kalbakis K, Polyzos A, Christofillakis C, Kentepozidis N, Pistamaltzian N, Kourousis C, Vamvakas L, Georgoulias V, Mavroudis D. Weekly Paclitaxel and Carboplatin Plus Bevacizumab as First-Line Treatment of Metastatic Triple-Negative Breast Cancer. A Multicenter Phase II Trial by the Hellenic Oncology Research Group. Clin Breast Cancer. 2018 Feb;18(1):88-94. doi: 10.1016/j.clbc.2017.10.013. Epub 2017 Oct 24.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Bevacizumab	Monoclonal antibody	10 mg/kg	Intravenous
Subject	Carboplatin	Small molecule	—	Intravenous
Subject	Paclitaxel	Small molecule	90 mg/m2	Intravenous