NCT00755885

Abiraterone Acetate in Treating Postmenopausal Women With Advanced or Metastatic Breast Cancer

A Cancer Research UK Phase I/II Open Label Study to Evaluate the Safety, Endocrine Effects and Anti-tumour Activity of Abiraterone Acetate (CB7630) in Patients With Oestrogen (ER) or Androgen Receptor (AR) Positive Advanced or Metastatic Breast Carcinoma

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 77 (actual)
• Sponsor: Cancer Research UK · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

RATIONALE: Abiraterone acetate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. PURPOSE: This phase I/II trial is studying the side effects and best dose of abiraterone acetate and to see how well it works in treating postmenopausal women with advanced or metastatic breast cancer.

Detailed description

OBJECTIVES: Primary * To evaluate the safety and tolerability of abiraterone acetate in postmenopausal women with estrogen receptor- or androgen receptor-positive advanced or metastatic breast cancer. (Phase I) * To determine the recommended phase II dose of this drug in these patients. (Phase I) * To evaluate the clinical benefit rate of this drug at 24 weeks in these patients. (Phase II) Secondary * To study the pharmacokinetics of this drug in these patients. (Phase I) * To determine the endocrine impact of this drug on the pituitary-adrenal-gonad endocrine axis. (Phase I) * To estimate the duration of objective tumor response in these patients. (Phase II) * To correlate response rates and duration of response with the endocrine profile in these patients. (Phase II) * To determine overall survival of these patients. (Phase II) Tertiary * To enumerate and molecularly characterize circulating tumor cells. * To identify normal genetic variations that predict resistance to this drug using pharmacogenomic analysis. OUTLINE: This is a multicenter, phase I study followed by a phase II study. Patients enrolled in the phase II portion of the study are stratified according to hormone receptor status (estrogen receptor \[ER\]-positive and any androgen receptor \[AR\] status vs AR-positive and ER-negative). Patients receive oral abiraterone acetate once daily on days 1-28. Treatment repeats every 28 days for 12 courses in the absence of disease progression or unacceptable toxicity. Blood samples are collected periodically and analyzed for pharmacokinetic assays (phase I only), pharmacodynamic assays, circulating tumor cells, and pharmacogenomic analysis. After completion of study treatment, patients are followed for 28 days. Peer Reviewed and Funded or Endorsed by Cancer Research UK.

Conditions

• Breast Cancer

Interventions

Type	Name	Description
DRUG	abiraterone acetate
OTHER	laboratory biomarker analysis
OTHER	pharmacogenomic studies

Timeline

• Start date: 2008-10-01
• Primary completion: 2016-06-04
• Completion: 2016-06-04
• First posted: 2008-09-19
• Last updated: 2017-01-26

Locations

6 sites across 1 country: United Kingdom