A Study of Abiraterone Acetate Plus Prednisone With or Without Exemestane in Postmenopausal Women With Estrogen Receptor-Positive (ER+) Metastatic Breast Cancer Progressing After Letrozole or Anastrozole Therapy

Summary

The purpose of this study is to assess the safety and efficacy of oral abiraterone acetate plus oral prednisone and oral abiraterone acetate plus oral prednisone plus oral exemestane, each compared with oral exemestane alone, in postmenopausal women with estrogen receptor-positive (ER+) metastatic (spreading) breast cancer that has relapsed after treatment with letrozole or anastrozole.

Timeline

Start

2011-08-24

Primary completion

2014-07-28

Completion

2018-08-08

Outcome

Missed primary endpoint

registry analysis (superiority test); Exemestane vs Abiraterone Acetate + Prednisone; p = 0.437; Hazard Ratio (HR) 1.143 (95% CI 0.816 to 1.603) NCT01381874 ↗

registry analysis (superiority test); Exemestane vs Abiraterone Acetate + Prednisone; p = 0.807; Hazard Ratio (HR) 1.074 (95% CI 0.608 to 1.896) NCT01381874 ↗

paper There was no significant difference in PFS with AA versus E (3.7 versus 3.7 months; hazard ratio [HR] = 1.1; 95% confidence interval [CI] 0.82-1.60; P = 0.437) PMID 26504153 ↗

Publications

• O'Shaughnessy J, Campone M, Brain E, Neven P, Hayes D, Bondarenko I, Griffin TW, Martin J, De Porre P, Kheoh T, Yu MK, Peng W, Johnston S. Abiraterone acetate, exemestane or the combination in postmenopausal patients with estrogen receptor-positive metastatic breast cancer. Ann Oncol. 2016 Jan;27(1):106-13. doi: 10.1093/annonc/mdv487. Epub 2015 Oct 26.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Abiraterone acetate	Small molecule	1000 mg	Oral
Subject	Exemestane	Small molecule	25 mg	Oral
Subject	Prednisolone	Other / unclassified	5 mg	Oral
Subject	Prednisone	Other / unclassified	5 mg	Oral

Indications