Status:
WITHDRAWN
Anti-Proliferative Effects and Genomic Alterations of Abiraterone Acetate Compared to an Aromatase Inhibitor in Post-menopausal HR+ Operable Breast Cancer
Lead Sponsor:
British Columbia Cancer Agency
Collaborating Sponsors:
Janssen Research & Development, LLC
Conditions:
Post-menopausal ER+ Stage I-IIIA Primary Operable Breast Cancer
Eligibility:
FEMALE
18+ years
Phase:
PHASE2
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 can...
Eligibility Criteria
Inclusion
- 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
- serum albumin greater than or equal 3.0 g/dL
- INR (or PT) and partial thromboplastin time (PTT) within normal limits
- Systolic blood pressure \<180 mm Hg and diastolic blood pressure \<100 mm Hg \[Note: Hypertension controlled by antihypertensive therapy is permitted\].
- Willing and able to adhere to prohibitions and restrictions specified in this protocol
- Signs an informed consent document within 4 weeks before randomization indicating she understands the purpose of and procedures required for the study and is willing to participate in the study
Exclusion
- 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
Key Trial Info
Start Date :
May 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2013
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT01814865
Start Date
May 1 2013
End Date
December 1 2013
Last Update
December 20 2013
Active Locations (4)
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1
BC Cancer Agency - Vancouver Centre
Vancouver, British Columbia, Canada, V5Z 4E6
2
London Regional Cancer Program
London, Ontario, Canada, N6A 4L6
3
The Ottawa Hospital Regional Cancer Centre
Ottawa, Ontario, Canada, K1H 8L6
4
Segal Cancer Centre
Montreal, Quebec, Canada, H3T 1E2