Trebananib (AMG 386) plus weekly paclitaxel with or without bevacizumab as first-line therapy for HER2-negative locally recurrent or metastatic breast cancer: A phase 2 randomized study

The Breast : Official Journal of the European Society of Mastology
Véronique DiérasDennis J Slamon

Abstract

This phase 2 randomized study evaluated trebananib (AMG 386), a peptide-Fc fusion protein that inhibits angiogenesis by neutralizing the interaction of angiopoietin-1 and -2 with Tie2, in combination with paclitaxel with or without bevacizumab in previously untreated patients with HER2-negative locally recurrent/metastatic breast cancer. Patients received paclitaxel 90 mg/m(2) once weekly (3-weeks-on/1-week-off) and were randomly assigned 1:1:1:1 to also receive blinded bevacizumab 10 mg/kg once every 2 weeks plus either trebananib 10 mg/kg once weekly (Arm A) or 3 mg/kg once weekly (Arm B), or placebo (Arm C); or open-label trebananib 10 mg/kg once a week (Arm D). Progression-free survival was the primary endpoint. In total, 228 patients were randomized. Median estimated progression-free survival for Arms A, B, C, and D was 11.3, 9.2, 12.2, and 10 months, respectively. Hazard ratios (95% CI) for Arms A, B, and D versus Arm C were 0.98 (0.61-1.59), 1.12 (0.70-1.80), and 1.28 (0.79-2.09), respectively. The objective response rate was 71% in Arm A, 51% in Arm B, 60% in Arm C, and 46% in Arm D. The incidence of grade 3/4/5 adverse events was 71/9/4%, 61/14/5%, 62/16/3%, and 52/4/7% in Arms A/B/C/D. In Arm D, median progression-fre...Continue Reading

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Citations

Sep 28, 2018·Hepatology : Official Journal of the American Association for the Study of Liver Diseases·Sander LefereLindsey Devisscher
Feb 27, 2019·Current Oncology Reports·Jessica GillenKathleen Moore
Jul 26, 2019·BMC Cancer·Leena TiainenPirkko-Liisa Kellokumpu-Lehtinen
Sep 2, 2020·The Journal of Clinical Investigation·Ellen C de HeerAdrian L Harris
Dec 22, 2017·Biopolymers·Marco CavacoVera Neves
Jan 8, 2017·Breast Cancer Research and Treatment·Rajesh RamanathanKazuaki Takabe
Dec 9, 2017·Clinical Cancer Research : an Official Journal of the American Association for Cancer Research·Manuel HidalgoOliver Krieter
Jun 3, 2016·Clinical Cancer Research : an Official Journal of the American Association for Cancer Research·Andrew R Chin, Shizhen Emily Wang
Nov 30, 2016·Clinical Cancer Research : an Official Journal of the American Association for Cancer Research·Daniela F Quail, Johanna A Joyce
Mar 21, 2021·European Journal of Pharmacology·Digna Parmar, Madhavi Apte
Apr 4, 2021·Cancers·Tomohiro FujiwaraToshifumi Ozaki

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