Phase 2, Abiraterone Acetate in Metastatic Breast Cancer 212082BCA2001

• Research type

  Research Study

• Full title

  Randomized, Open-Label Study of Abiraterone Acetate (JNJ-212082) Plus Prednisolone With or Without Exemestane in Postmenopausal Women With ER+ Metastatic Breast Cancer Progressing After Letrozole or Anastrozole Therapy

• IRAS ID

  78682

• Contact name

  Andreas Makris

• Sponsor organisation

  Janssen-Cilag International NV

• Eudract number

  2011-000621-80

• Research summary

  This study is being conducted on behalf of Johnson & Johnson Pharmaceutical Research & Development and is being performed on postmenopausal women at least 18 years of age with ER(Estrogen receptor positive) metastatic breast cancer. Breast cancer is the most frequent cancer among women with an estimated 1.38 million cases newly diagnosed worldwide in 2008. The 5-year survival rate for women with metastatic breast cancer is 15% (American Cancer Society 2010b), which reflects a substantial unmet medical need for more effective therapy. Abiraterone Acetate is a novel selective irreversible inibitor of the enzyme cytochrome P450 CYP17. Inhibition of this enzyme has been shown to result in supression of the synthesis of both androgens and oestrogens, which may impact breast cancer cell growth in ER women.Abiraterone Acetate has recently been approved by the FDA for use in metastatic prostate cancer and there is cuurently a phase I/II trial to look at best dose and side-effects in postmenopausal women with advanced/metastatic breast cancer.This is a randomized, open-label, parallel-group, multicenter Phase 2 study of abiraterone acetate plus prednisolone and abiraterone acetate plus prednisolone combined with exemestane, each compared with exemestane alone, in postmenopausal women with ER metastatic breast cancer progressing after letrozole or anastrozole therapy. This study is divided into three phases: Screening, Treatment, and Follow-Up. The Treatment phase comprises a series of 28-day cycles with continuous study treatment until disease progression, when an End-of-Treatment visit is completed before the Follow-Up phase begins. At selected study sites, PK, circulating tumour cells (CTC), and fresh tumour biopsies are assessed.This Phase 2 study will involve approximately 65 sites in North America, Europe, and Asia. Approximately 300 subjects will be randomized into three treatment groups and the study is expected to last about 3 years.

• REC name

  London - Westminster Research Ethics Committee

• REC reference

  11/LO/0854

• Date of REC Opinion

  17 Aug 2011

• REC opinion

  Further Information Favourable Opinion