Abiraterone Acetate in Treating Postmenopausal Women With Advanced or Metastatic Breast Cancer
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.
Drug: abiraterone acetate
Other: laboratory biomarker analysis
Other: pharmacogenomic studies
|Study Design:||Allocation: Non-Randomized
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||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|
- Causality of each adverse event and grading severity as measured by NCI CTCAE v3.0 (Phase I) [ Designated as safety issue: Yes ]
- Maximum tolerated dose (MTD) of abiraterone acetate (Phase I) [ Designated as safety issue: Yes ]
- Proportion of patients with stable disease for ≥ 24 weeks or objective response as measured by RECIST criteria (Phase II) [ Designated as safety issue: No ]
- Plasma levels of abiraterone acetate as measured by liquid chromatography/tandem mass spectrometry assay (Phase I) [ Designated as safety issue: No ]
- Relationship between dose and endocrine response (Phase I) [ Designated as safety issue: No ]
- Duration of objective tumor response as measured by RECIST criteria (Phase II) [ Designated as safety issue: No ]
- Relationship between tumor response and endocrine response (Phase II) [ Designated as safety issue: No ]
- Median overall survival (Phase II) [ Designated as safety issue: No ]
|Study Start Date:||October 2008|
|Estimated Primary Completion Date:||March 2014 (Final data collection date for primary outcome measure)|
- 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)
- 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)
- 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.
|London, England, United Kingdom, SE1 9RT|
|Contact: Contact Person 207-188-4237|
|Royal Marsden - Surrey||Recruiting|
|Sutton, England, United Kingdom, SM2 5PT|
|Contact: Contact Person 44-208-722-4028 Johann.De-Bono@icr.ac.uk|
|University of Birmingham,||Recruiting|
|Birmingham, United Kingdom, B15 2TT|
|Contact: Contact Person 0121 414 7611 firstname.lastname@example.org|
|Western General Hospital||Recruiting|
|Edinburgh, United Kingdom, EH4 2XU|
|Contact: Contact Person 0131 537 1042 Angela.Bowman@ed.ac.uk|
|The Beatson West of Scotland Cancer Centre||Recruiting|
|Glasgow, United Kingdom, G12 0YN|
|Contact: Contact Person 0141 301 7128 Iain.MacPherson@ggc.scot.nhs.uk|
|Principal Investigator:||Johann Sebastian de Bono, MD||Cancer Research UK|