Metronomic Low-Dose Cyclophosphamide and Methotrexate With or Without Bevacizumab in Treating Women With Metastatic Breast Cancer

Phase 2 Completed 57 enrolled Dana-Farber Cancer Institute Genentech, Inc. · collab National Cancer Institute (NCI) · collab

RandomizedParallel-groupOpen-labelTreatment

Summary

This randomized phase II trial is studying metronomic low-dose cyclophosphamide and methotrexate to see how well they work compared to metronomic low-dose cyclophosphamide, methotrexate, and bevacizumab in treating women with metastatic breast cancer.

Timeline

Start: 2003-07
Primary completion: 2006-08
Completion: 2009-08

Outcome

Missed primary endpoint

paper The ORR was modestly higher in Arm A (26%) than in Arm B (10%); neither met the 40% cutoff for further clinical evaluation. PMID 38019444 ↗

Publications

Mayer EL, Tayob N, Ren S, Savoie JJ, Spigel DR, Burris HA 3rd, Ryan PD, Harris LN, Winer EP, Burstein HJ. A randomized phase II study of metronomic cyclophosphamide and methotrexate (CM) with or without bevacizumab in patients with advanced breast cancer. Breast Cancer Res Treat. 2024 Feb;204(1):123-132. doi: 10.1007/s10549-023-07167-9. Epub 2023 Nov 29.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Bevacizumab	Monoclonal antibody	—	Intravenous
Background	Cyclophosphamide	Other / unclassified	—	Oral
Background	Methotrexate	Small molecule	—	—