Post-menopausal ER+ Stage I-IIIA Primary Operable Breast CancerPhase 2NCT01814865
Anti-Proliferative Effects and Genomic Alterations of Abiraterone Acetate Compared to an Aromatase Inhibitor in Post-menopausal HR+ Operable Breast Cancer
A Phase 2 study testing Abiraterone Acetate, Prednisone and Aromatase Inhibitor in people with Post-menopausal ER+ Stage I-IIIA Primary Operable Breast Cancer, run by British Columbia Cancer Agency at 4 sites in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Post-menopausal ER+ Stage I-IIIA Primary Operable Breast Cancer
- What is being tested?
- Abiraterone Acetate, Prednisone and Aromatase Inhibitor
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 4 sitesCanada
- Study dates
- May 2013to Dec 2013
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
4 sites in 1 country.
Canada4 sites
London Regional Cancer Program
London, Ontario, N6A 4L6
Segal Cancer Centre
Montreal, Quebec, H3T 1E2
The Ottawa Hospital Regional Cancer Centre
Ottawa, Ontario, K1H 8L6
BC Cancer Agency - Vancouver Centre
Vancouver, British Columbia, V5Z 4E6
About this study
Official title: 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
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
- Being tested
- Abiraterone Acetate, Prednisone, Aromatase Inhibitor
- Keywords
- Post-menopausal, ER+, Stage I-IIIA, Operable, Breast Cancer
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Abiraterone AcetateDrug
1000 mg PO OD x 2 weeks
PrednisoneDrug
5 mg PO OD x 2 weeks
Aromatase InhibitorDrug
Also called Anastrozole
1 mg PO OD x 2 weeks
| Study group | Role | What they receive |
|---|---|---|
| Abiraterone Acetate + Prednisone | Experimental | Abiraterone 1000mg PO OD + Prednisone 5mg PO OD x 2 weeks Receives: Drug: Abiraterone Acetate; Drug: Prednisone |
| Aromatase Inhibitor | Active comparator | Anastrozole 1mg PO OD x 2 weeks Receives: Drug: Aromatase Inhibitor |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 2 weeks (baseline and day 14)
Secondary outcomes (3)
Change in proliferation
To compare the magnitude in change in proliferation (Ki67 as measured by IHC) with abiraterone acetate plus prednisone relative to changes in proliferation with an aromatase inhibitor following 2 weeks of pre-operative therapy
Measured: 2 weeks (baseline and day 14)
Resulting adverse events of two weeks of abiraterone acetate
To evaluate the safety of two weeks of abiraterone acetate plus prednisone in this pre-operative population of patients.
Safety analyses will analyze treatment-emergent adverse events coded using MedDRA resulting in death, serious adverse events, discontinuation, modification and dose interruption or day. Other safety endpoints include vital signs and clinical laboratory parameters.
Measured: 2 weeks (baseline and day 14)
Changes in plasma hormone levels
To evaluate the changes in plasma hormone levels (androgens and estrogens) from baseline to after 2 weeks of abiraterone acetate plus prednisone
Measured: 2 weeks (baseline and day 14)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2013 (estimated)
- Study startMay 2013
- Primary completionDec 2013
- Study completionDec 2013
Why it stopped: Funding was not acquired
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post-menopausal ER+ Stage I-IIIA Primary Operable Breast CancerStudies of the same condition, open and under way.
- More trials run by British Columbia Cancer AgencyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- British Columbia Cancer Agency
- Sponsor type
- University, hospital or other
- Collaborators
- Janssen Research & Development, LLC
- Responsible party
- Sponsor
- Investigators
- Stephen Chia, MD, Principal investigator, British Columbia Cancer Agency
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01814865
- Sponsor's protocol ID
- 212082BCA2004
- Status last verified
- Dec 2013
- First submitted
- 13 Mar 2013
- Last updated
- 20 Dec 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Dec 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT01814865
- Acronym / sponsor ID
- 212082BCA2004
- Keywords
- Post-menopausal, ER+, Stage I-IIIA, Operable, Breast Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Funding was not acquired
- Enrolment
- 0 participants (actual)
- Lead sponsor
- British Columbia Cancer AgencyUniversity, hospital or other
- Collaborators
- Janssen Research & Development, LLC
- Study start
- May 2013
- Primary completion
- Dec 2013 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 20 Mar 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Abiraterone Acetate + Prednisone | Experimental | Drug: Abiraterone Acetate, Drug: PrednisoneAbiraterone 1000mg PO OD + Prednisone 5mg PO OD x 2 weeks |
| Aromatase Inhibitor | Active comparator | Drug: Aromatase InhibitorAnastrozole 1mg PO OD x 2 weeks |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (20 listed)
- Woman greater than or equal to 18 years of age and postmenopausal determined by one of the following:
- 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:
- Systolic blood pressure <180 mm Hg and diastolic blood pressure <100 mm Hg [Note: Hypertension controlled by antihypertensive therapy is permitted].
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Abiraterone Acetate1000 mg PO OD x 2 weeks | Drug | Abiraterone Acetate + Prednisone |
| Prednisone5 mg PO OD x 2 weeks | Drug | Abiraterone Acetate + Prednisone |
| Aromatase InhibitorAlso: Anastrozole1 mg PO OD x 2 weeks | Drug | Aromatase Inhibitor |
Primary outcome
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
3 secondary outcomes
Change in proliferation
Time frame: 2 weeks (baseline and day 14)
Resulting adverse events of two weeks of abiraterone acetate
Time frame: 2 weeks (baseline and day 14)
Changes in plasma hormone levels
Time frame: 2 weeks (baseline and day 14)
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Dec 2013.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Stephen Chia, MD principal investigator
British Columbia Cancer Agency
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Abiraterone Acetate, Prednisone and Aromatase Inhibitor in people with Post-menopausal ER+ Stage I-IIIA Primary Operable Breast Cancer, run by British Columbia Cancer Agency at 4 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 20 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 20 Dec 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Differences in genomic expression and biological activity (time frame: 2 weeks (baseline and day 14)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Dec 2013.