Breast Cancer Study: Paclitaxel Versus Paclitaxel Plus Sorafenib in Second- or Third-line Treatment

Summary

AIM OF STUDY Primary Efficacy Variable: The primary study objective is the proof of efficacy, measured by progression free survival (PFS) in the treatment of metastatic or locally inoperable recurrent breast cancer. Progression-free survival (PFS) is defined as the time from randomisation to disease progression or death. Secondary Efficacy Variables: * Clinical benefit (CR+PR+SD) * ORR (CR+PR) * Time to progression * Time to next Treatment (TTT) * Overall survival * Safety profile

Timeline

Start

2010-07-01

Primary completion

2014-08-31

Completion

2014-08-31

Outcome

Missed primary endpoint

paper paclitaxel-sorafenib combination therapy was not found to be superior to paclitaxel monotherapy with regard to the primary end point, progression-free survival. PMID 28743247 ↗

Publications

• Background Seidman AD, Berry D, Cirrincione C, Harris L, Muss H, Marcom PK, Gipson G, Burstein H, Lake D, Shapiro CL, Ungaro P, Norton L, Winer E, Hudis C. Randomized phase III trial of weekly compared with every-3-weeks paclitaxel for metastatic breast cancer, with trastuzumab for all HER-2 overexpressors and random assignment to trastuzumab or not in HER-2 nonoverexpressors: final results of Cancer and Leukemia Group B protocol 9840. J Clin Oncol. 2008 Apr 1;26(10):1642-9. doi: 10.1200/JCO.2007.11.6699.
• Background Gradishar W, Kaklamani V, Prasad Sahoo T. A double-blind, randomized, placebo-controlled, Phase 2b study evaluating the efficacy and safety of sorafenib (SOR) in combination with Paclitaxel (PAC) as a first-line therapy in patients with locally recurrent or metastatic breast cancer. Presented at : 32nd Annual San Antonio Breast Cancer Symposium. 2009 Dez 10;(Abstract 44).
• Decker T, Overkamp F, Rosel S, Nusch A, Gohler T, Indorf M, Sahlmann J, Trarbach T. A randomized phase II study of paclitaxel alone versus paclitaxel plus sorafenib in second- and third-line treatment of patients with HER2-negative metastatic breast cancer (PASO). BMC Cancer. 2017 Jul 25;17(1):499. doi: 10.1186/s12885-017-3492-1.

Drugs

Indications