Pre-operative Assessment of the Anti-Proliferative Effects and Genomic Alterations of 2 Weeks of Abiraterone Acetate Compared to 2 Weeks of an Aromatase Inhibitor in Post-menopausal Hormone Receptor Positive Operable Breast Cancer

British Columbia Cancer Agency4 sites in 1 countryMay 2013

ConditionsPost-menopausal ER+ Stage I-IIIA Primary Operable Breast Cancer

InterventionsAbiraterone Acetate Prednisone Aromatase Inhibitor

DrugsAbiraterone Acetate Prednisone Aromatase Inhibitor

Overview

Phase: Phase 2
Intervention: Abiraterone Acetate
Conditions: Post-menopausal ER+ Stage I-IIIA Primary Operable Breast Cancer
Sponsor: British Columbia Cancer Agency
Locations: 4
Primary Endpoint: Differences in genomic expression and biological activity
Status: Withdrawn
Last Updated: 12 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

This study is being offered to patients who are post-menopausal, have breast cancer with a positive estrogen and/or progesterone hormone receptor test and are currently awaiting surgery for breast cancer.

The purpose of this study is to determine whether abiraterone acetate has different hormonal and genomic effects than non-steroidal aromatase inhibitors in the treatment of post-menopausal hormonal receptor positive primary operable breast cancer

Registry

clinicaltrials.gov

Start Date

May 2013

End Date

December 2013

Last Updated

12 years ago

Study Type

Interventional

Study Design

Parallel

Sex

Female

Investigators

Sponsor

British Columbia Cancer Agency

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Woman greater than or equal to 18 years of age and postmenopausal determined by one of the following:
•bilateral surgical oophorectomy
•age greater than or equal 60 years
•age \<60 years, with amenorrhea greater than or equal 24 months and follicle-stimulating hormone and luteinizing hormone concentrations within postmenopausal range
•Subjects with ER+ (Allred 3-8), HER2 - primary operable T1-T3 breast cancer with a primary tumor size of ≥ 1.5 cm on physical examination or imaging studies
•Eastern Cooperative Oncology Group (ECOG) performance status score of less than or equal to 1
•Criterion modified per amendment 7.1 Clinical laboratory values during Screening:
•hemoglobin greater than or equal 10.0 g/dL
•neutrophils greater than or equal 1.5 x 109/L
•platelets greater than or equal100 x 109/L

Exclusion Criteria

•Prior treatment with ketoconazole, aminoglutethimide or a CYP17 inhibitor. \[Note: Prior treatment with ketoconazole for ≤7 days is permitted and topical formulations of ketoconazole are permitted\]
•Anticancer immunotherapy, investigational agent, anticancer radiotherapy or anticancer endocrine therapy within 12 weeks before randomization
•Use of hormone replacement therapy within the past 4 weeks
•Serious or uncontrolled nonmalignant disease, including active or uncontrolled infection
•Clinical or biochemical evidence of hyper-aldosteronism or hypopituitarism
•Any condition that, in the opinion of the investigator, would compromise the well-being of the patient or that could prevent, limit, or confound the protocol-specified assessments
•Major thoracic or abdominal surgery or significant traumatic injury with 4 weeks before randomization \[Note: Patients with planned surgical procedures to be conducted under local anesthesia are not excluded from the study (e.g. intravascular device insertion)\]
•Gastrointestinal disorder interfering with study drug absorption
•Positive serology for hepatitis B surface antigen or hepatitis C antibody
•Active or symptomatic viral hepatitis or chronic liver disease

Arms & Interventions

Abiraterone Acetate + Prednisone

Abiraterone 1000mg PO OD + Prednisone 5mg PO OD x 2 weeks

Intervention: Abiraterone Acetate

Abiraterone Acetate + Prednisone

Abiraterone 1000mg PO OD + Prednisone 5mg PO OD x 2 weeks

Intervention: Prednisone

Aromatase Inhibitor

Anastrozole 1mg PO OD x 2 weeks

Intervention: Aromatase Inhibitor

Outcomes

Primary Outcomes

Differences in genomic expression and biological activity

Time Frame: 2 weeks (baseline and day 14)

To determine the differences in genomic expression changes with 2 weeks of abiraterone acetate plus prednisone relative to changes with 2 weeks of an aromatase inhibitor as a means to assess for potential differences in biological activity between abiraterone acetate and aromatase inhibitors in breast cancer

Secondary Outcomes

Change in proliferation(2 weeks (baseline and day 14))
Resulting adverse events of two weeks of abiraterone acetate(2 weeks (baseline and day 14))
Changes in plasma hormone levels(2 weeks (baseline and day 14))