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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

Phase 2
18 Years
Not Enrolling
Post-menopausal ER+ Stage I-IIIA Primary Operable Breast Cancer

Thank you

Trial Information

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

Inclusion Criteria:

1. 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

2. 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

3. Eastern Cooperative Oncology Group (ECOG) performance status score of less than or
equal to 1

4. 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

- 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

5. Systolic blood pressure <180 mm Hg and diastolic blood pressure <100 mm Hg [Note:
Hypertension controlled by antihypertensive therapy is permitted].

6. Willing and able to adhere to prohibitions and restrictions specified in this

7. 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 Criteria:

1. 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]

2. Anticancer immunotherapy, investigational agent, anticancer radiotherapy or
anticancer endocrine therapy within 12 weeks before randomization

3. Use of hormone replacement therapy within the past 4 weeks

4. Serious or uncontrolled nonmalignant disease, including active or uncontrolled

5. Clinical or biochemical evidence of hyper-aldosteronism or hypopituitarism

6. 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

7. 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

8. Gastrointestinal disorder interfering with study drug absorption

9. Positive serology for hepatitis B surface antigen or hepatitis C antibody

10. Active or symptomatic viral hepatitis or chronic liver disease

11. 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

12. Known allergies, hypersensitivity, or intolerance to abiraterone acetate, prednisone,
or their excipients

13. 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

Type of Study:


Study Design:

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Basic Science

Outcome Measure:

Differences in genomic expression and biological activity

Outcome Description:

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

Outcome Time Frame:

2 weeks (baseline and day 14)

Safety Issue:


Principal Investigator

Stephen Chia, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

British Columbia Cancer Agency


Canada: Health Canada

Study ID:




Start Date:

May 2013

Completion Date:

March 2014

Related Keywords:

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