Trial of Vinflunine Versus Alkylating Agent in Metastatic Breast Cancer

Phase 3 Completed 594 enrolled Pierre Fabre Laboratories

RandomizedParallel-groupOpen-labelTreatment

Summary

In metastatic breast cancer (MBC) patients who have already received anthracyclines, taxanes, antimetabolites and vinca-alkaloids and have developed drug resistance to these drugs, therapeutic options are very limited. Alkylating agents showed a modest activity in pretreated metastatic breast cancer. This phase III trial will compare the effectiveness and the safety profile of vinflunine to an alkylating agent of physician choice in MBC patients who have exhausted anthracyclines, taxanes, antimetabolites and vinca-alkaloids.

Timeline

Start: 2009-07
Primary completion: 2012-08-27
Completion: 2014-01

Outcome

Missed primary endpoint

registry analysis (superiority test); Vinflunine vs Alkylating Agent; p = 0.673 NCT01091168 ↗

Publications

Cortes J, Perez-Garcia J, Levy C, Gomez Pardo P, Bourgeois H, Spazzapan S, Martinez-Janez N, Chao TC, Espie M, Nabholtz JM, Gonzalez Farre X, Beliakouski V, Roman Garcia J, Holgado E, Campone M. Open-label randomised phase III trial of vinflunine versus an alkylating agent in patients with heavily pretreated metastatic breast cancer. Ann Oncol. 2018 Apr 1;29(4):881-887. doi: 10.1093/annonc/mdy051.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Carboplatin	Small molecule	—	—
Subject	Cisplatin	Other / unclassified	—	—
Subject	Cyclophosphamide	Other / unclassified	—	—
Subject	Melphalan	Small molecule	—	—
Subject	Mitomycin C	Other / unclassified	—	—
Subject	Thiotepa	Other / unclassified	—	—
Subject	Vinflunine	Small molecule	280 mg/m2	Intravenous