Anti-Proliferative Effects and Genomic Alterations of Abiraterone Acetate Compared to an Aromatase Inhibitor in Post-menopausal HR+ Operable Breast Cancer

NCT01814865 | Withdrawn Phase 2

• 1 other identifier: 212082BCA2004
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 4

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

Conditions

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

Keywords

Post-menopausal; ER+; Stage I-IIIA; Operable; Breast Cancer

Outcome Measures

Primary Outcomes (1)

• Differences in genomic expression and biological activity

  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

  2 weeks (baseline and day 14)

Secondary Outcomes (3)

• 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)

Study Arms (2)

Abiraterone Acetate + Prednisone

EXPERIMENTAL

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

Drug: Abiraterone Acetate; Drug: Prednisone

Aromatase Inhibitor

ACTIVE COMPARATOR

Anastrozole 1mg PO OD x 2 weeks

Drug: Aromatase Inhibitor

Interventions

Abiraterone Acetate DRUG

1000 mg PO OD x 2 weeks

Abiraterone Acetate + Prednisone

Prednisone DRUG

5 mg PO OD x 2 weeks

Abiraterone Acetate + Prednisone

Aromatase Inhibitor DRUG

1 mg PO OD x 2 weeks

Also known as: Anastrozole

Aromatase Inhibitor

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• total bilirubin less than or equal to 1.5x upper limit of normal (ULN) - except for a known diagnosis of Gilbert's syndrome
• alanine (ALT) and aspartate (AST) aminotransferase less than or equal to 1.5xULN
• alkaline phosphatase less than or equal to 1.5xULN
• serum creatinine \<1.5xULN or creatinine clearance greater than or equal 45 mL/min
• serum potassium greater than or equal 3.5 mM

You may not qualify if:

• 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
• History of clinically significant heart disease, ie, myocardial infarction or arterial thrombotic event within 6 months, severe or unstable angina, or New York Heart Association Class III or IV heart disease
• Known allergies, hypersensitivity, or intolerance to abiraterone acetate, prednisone, or their excipients
• Received an investigational drug (including investigational vaccines) or used an invasive investigational medical device within 4 weeks before the planned first dose of study drug or is currently enrolled in an investigational study

Sponsors & Collaborators

• British Columbia Cancer Agency: lead
• Janssen Research & Development, LLC: collaborator

Study Sites (4)

BC Cancer Agency - Vancouver Centre

Vancouver, British Columbia, V5Z 4E6, Canada

Location

London Regional Cancer Program

London, Ontario, N6A 4L6, Canada

Location

The Ottawa Hospital Regional Cancer Centre

Ottawa, Ontario, K1H 8L6, Canada

Location

Segal Cancer Centre

Montreal, Quebec, H3T 1E2, Canada

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Abiraterone Acetate; Prednisone; Aromatase Inhibitors; Anastrozole

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Androstenes; Androstanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Pregnadienediols; Pregnadienes; Pregnanes; Steroid Synthesis Inhibitors; Enzyme Inhibitors; Molecular Mechanisms of Pharmacological Action; Pharmacologic Actions; Chemical Actions and Uses; Estrogen Antagonists; Hormone Antagonists; Hormones, Hormone Substitutes, and Hormone Antagonists; Physiological Effects of Drugs; Nitriles; Organic Chemicals; Triazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Stephen Chia, MD

  British Columbia Cancer Agency

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 13, 2013
• First Posted: March 20, 2013
• Study Start: May 1, 2013
• Primary Completion: December 1, 2013
• Study Completion: December 1, 2013
• Last Updated: December 20, 2013

Record last verified: 2013-12

Locations

CA (4)