A Study of Abiraterone Acetate Plus Prednisone With or Without Exemestane in Postmenopausal Women With Estrogen Receptor-Positive (ER+) Metastatic Breast Cancer Progressing After Letrozole or Anastrozole Therapy
Randomized, Open-Label Study of Abiraterone Acetate (JNJ-212082) Plus Prednisone With or Without Exemestane in Postmenopausal Women With ER+ Metastatic Breast Cancer Progressing After Letrozole or Anastrozole Therapy
3 other identifiers
interventional
297
12 countries
81
Brief Summary
The purpose of this study is to assess the safety and efficacy of oral abiraterone acetate plus oral prednisone and oral abiraterone acetate plus oral prednisone plus oral exemestane, each compared with oral exemestane alone, in postmenopausal women with estrogen receptor-positive (ER+) metastatic (spreading) breast cancer that has relapsed after treatment with letrozole or anastrozole.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Aug 2011
Longer than P75 for phase_2
81 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 23, 2011
CompletedFirst Posted
Study publicly available on registry
June 27, 2011
CompletedStudy Start
First participant enrolled
August 24, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 28, 2014
CompletedResults Posted
Study results publicly available
July 27, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
August 8, 2018
CompletedApril 11, 2019
March 1, 2019
2.9 years
June 23, 2011
May 9, 2018
March 28, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Progression-Free Survival (PFS)
Progression-free survival was defined as the time from randomization to first occurrence of disease progression (either radiographic or clinical), or death from any cause. PFS was determined using radiographic progression defined by Response Evaluation Criteria in Solid Tumors (RECIST) on measurable lesions captured by computed tomography (CT) or magnetic resonance imaging (MRI). Clinical disease progression was considered only when disease progression could not be confirmed by CT or MRI, such as when the disease site is skin, bone marrow, or central nervous system.
Approximately 2 years
Overall Survival (OS)
OS was calculated as the time from randomization to death from any cause.
Approximately 3 years
Secondary Outcomes (5)
Overall Response Rate (ORR)
Approximately 2 years
Clinical Benefit Rate
Approximately 2 years
Duration of Response
Approximately 2 years
Change From Baseline in Serum Endocrine Biomarkers (Estradiol and Estrone) at End of Treatment
Baseline and End of treatment (approximately 2 years)
Change From Baseline in Serum Endocrine Biomarkers (Progesterone and Testosterone) at End of Treatment
Baseline and End of treatment (approximately 2 years)
Study Arms (3)
Abiraterone acetate + Prednisone or Prednisolone
EXPERIMENTALAbiraterone acetate + Prednisone or Prednisolone Abiraterone acetate type=equal unit=mg number=250 form=tablet route=oral use 4 tablets Prednisone or Prednisolone type=equal unit=mg number=5 form=tablet route=oral use. All drugs are taken once daily.
Abiraterone acetate + Prednisone/Prednisolone + Exemestane
EXPERIMENTALAbiraterone acetate + Prednisone/Prednisolone + Exemestane Abiraterone acetate type=equal unit=mg number=250 form=tablet route=oral use 4 tablets Prednisone or Prednisolone type=equal unit=mg number=5 form=tablet route=oral use Exemestane type=equal unit=mg number=25 form=tablet route=oral use. All drugs are taken once daily.
Exemestane
EXPERIMENTALExemestane Exemestane type=equal unit=mg number=25 form=tablet route=oral use. All drugs are taken once daily.
Interventions
Abiraterone acetate, type=equal, unit=mg, number=250, form=tablet, route=oral use, 4 tablets
Prednisone or Prednisolone, type=equal, unit=mg, number=5, form=tablet, route=oral use. All drugs are taken once daily.
Abiraterone acetate, type=equal, unit=mg, number=250, form=tablet, route=oral use, 4 tablets
Eligibility Criteria
You may qualify if:
- Female patients must be postmenopausal
- ER+, Human epidermal growth factor receptor 2 (Her2) negative metastatic breast cancer
- Disease must have been sensitive to anastrozole or letrozole therapy prior to disease progression
- No more than two prior lines of therapy in the metastatic setting, of which no more than one was chemotherapy
- Eastern Cooperative Oncology Group (ECOG) performance status score of \<=1
- Patients with disease confined only to bone may be included, but patients with purely sclerotic lesions may not participate in the study
You may not qualify if:
- Prior treatment with exemestane, ketoconazole, aminoglutethimide, or a CYP17 inhibitor. Prior treatment with ketoconazole for \<= 7 days is permitted and topical formulations of ketoconazole are permitted
- Potential patients must not have taken anastrozole, letrozole, fulvestrant, or any chemotherapy for at least 2 weeks (bevacizumab for at least 3 weeks) before randomization
- Anticancer immunotherapy or investigational agent within 4 weeks before randomization, or anticancer radiotherapy (except palliative) or anticancer endocrine therapy within 2 weeks before randomization
- Serious or uncontrolled nonmalignant disease, including active or uncontrolled infection
- Clinical or biochemical evidence of hyperaldosteronism 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (81)
Unknown Facility
Muscle Shoals, Alabama, United States
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Fresno, California, United States
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Los Angeles, California, United States
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Monterey, California, United States
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Chicago, Illinois, United States
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Waterville, Maine, United States
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Boston, Massachusetts, United States
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Ann Arbor, Michigan, United States
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Henderson, Nevada, United States
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East Syracuse, New York, United States
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Johnson City, New York, United States
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New York, New York, United States
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Durham, North Carolina, United States
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Fargo, North Dakota, United States
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Cleveland, Ohio, United States
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Columbus, Ohio, United States
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Kettering, Ohio, United States
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Portland, Oregon, United States
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Sioux Falls, South Dakota, United States
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Dallas, Texas, United States
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El Paso, Texas, United States
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Houston, Texas, United States
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Tyler, Texas, United States
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Seattle, Washington, United States
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Antwerp, Belgium
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Brussels, Belgium
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Duffel, Belgium
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Edegem, Belgium
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Ghent, Belgium
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Hasselt, Belgium
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Leuven, Belgium
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Liège, Belgium
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Wilrijk, Belgium
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Bordeaux, France
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Caen, France
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Pierre-BĂ©nite, France
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Saint-Cloud, France
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Saint-Herblain, France
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Galway, Ireland
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Limerick, Ireland
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Luxembourg, Luxembourg
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Niedercorn, Luxembourg
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Alkmaar, Netherlands
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Amsterdam, Netherlands
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Heerlen, Netherlands
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Leeuwarden, Netherlands
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Leiden, Netherlands
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Rotterdam, Netherlands
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Sittard, Netherlands
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Bialystok, Poland
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Warsaw, Poland
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Chelyabinsk, Russia
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Kazan', Russia
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Leningrad Region, Russia
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Moscow, Russia
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Saint Petersburg, Russia
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Sochi, Russia
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Stavropol, Russia
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Vladimir, Russia
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Busan, South Korea
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Seoul, South Korea
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Suwon, South Korea
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Barcelona, Spain
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Madrid, Spain
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Seville, Spain
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Valencia, Spain
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Cherkasy, Ukraine
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Chernivtsi, Ukraine
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Dnipro, Ukraine
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Donetsk, Ukraine
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Kharkiv, Ukraine
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Odesa, Ukraine
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Uzhhorod, Ukraine
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Bath, United Kingdom
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Birmingham, United Kingdom
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Exeter, United Kingdom
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London, United Kingdom
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Nottingham, United Kingdom
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Plymouth, United Kingdom
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Sheffield, United Kingdom
Unknown Facility
Sutton, United Kingdom
Related Publications (1)
O'Shaughnessy J, Campone M, Brain E, Neven P, Hayes D, Bondarenko I, Griffin TW, Martin J, De Porre P, Kheoh T, Yu MK, Peng W, Johnston S. Abiraterone acetate, exemestane or the combination in postmenopausal patients with estrogen receptor-positive metastatic breast cancer. Ann Oncol. 2016 Jan;27(1):106-13. doi: 10.1093/annonc/mdv487. Epub 2015 Oct 26.
PMID: 26504153DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Senior Director Clinical Development
- Organization
- Janssen Research & Development, LLC
Study Officials
- STUDY DIRECTOR
Janssen Research & Development, LLC Clinical Trial
Janssen Research & Development, LLC
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 23, 2011
First Posted
June 27, 2011
Study Start
August 24, 2011
Primary Completion
July 28, 2014
Study Completion
August 8, 2018
Last Updated
April 11, 2019
Results First Posted
July 27, 2018
Record last verified: 2019-03