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Metastatic ER+ Her2- Breast CancerPhase 2NCT01381874

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

A Phase 2 study testing Exemestane, Abiraterone acetate + Prednisone/ Prednisolone + Exemestane and Abiraterone acetate + Prednisone or Prednisolone in people with Metastatic ER+ Her2- Breast Cancer and Postmenopausal, run by Janssen Research & Development, LLC at 81 sites in 12 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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… Read more about this study

Who is it for?
Ages 18 years and older, women only
What is being tested?
Exemestane, Abiraterone acetate + Prednisone/ Prednisolone + Exemestane and Abiraterone acetate + Prednisone or Prednisolone
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
297 participants
Where
81 sitesin 12 countries
Study dates
24 Aug 2011to 8 Aug 2018
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

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

  • 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

Who cannot join

  • 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

Trial locations and contacts

81 sites in 12 countries.

81 sites in 12 countries

United States24 sites

  • Study site

    Ann Arbor, Michigan

  • Study site

    Boston, Massachusetts

  • Study site

    Chicago, Illinois

  • Study site

    Cleveland, Ohio

  • Study site

    Columbus, Ohio

  • Study site

    Dallas, Texas

  • Study site

    Durham, North Carolina

  • Study site

    East Syracuse, New York

  • Study site

    El Paso, Texas

  • Study site

    Fargo, North Dakota

  • Study site

    Fresno, California

  • Study site

    Henderson, Nevada

  • Study site

    Houston, Texas

  • Study site

    Johnson City, New York

  • Study site

    Kettering, Ohio

  • Study site

    Los Angeles, California

  • Study site

    Monterey, California

  • Study site

    Muscle Shoals, Alabama

  • Study site

    New York, New York

  • Study site

    Portland, Oregon

  • Study site

    Seattle, Washington

  • Study site

    Sioux Falls, South Dakota

  • Study site

    Tyler, Texas

  • Study site

    Waterville, Maine

Other trials in United States

Belgium9 sites

  • Study site

    Antwerp

  • Study site

    Brussels

  • Study site

    Duffel

  • Study site

    Edegem

  • Study site

    Ghent

  • Study site

    Hasselt

  • Study site

    Leuven

  • Study site

    Liège

  • Study site

    Wilrijk

Other trials in Belgium

Russia8 sites

  • Study site

    Chelyabinsk

  • Study site

    Kazan'

  • Study site

    Leningrad Region

  • Study site

    Moscow

  • Study site

    Saint Petersburg

  • Study site

    Sochi

  • Study site

    Stavropol

  • Study site

    Vladimir

Other trials in Russia

United Kingdom8 sites

  • Study site

    Bath

  • Study site

    Birmingham

  • Study site

    Exeter

  • Study site

    London

  • Study site

    Nottingham

  • Study site

    Plymouth

  • Study site

    Sheffield

  • Study site

    Sutton

Other trials in United Kingdom

Netherlands7 sites

  • Study site

    Alkmaar

  • Study site

    Amsterdam

  • Study site

    Heerlen

  • Study site

    Leeuwarden

  • Study site

    Leiden

  • Study site

    Rotterdam

  • Study site

    Sittard

Other trials in Netherlands

Ukraine7 sites

  • Study site

    Cherkasy

  • Study site

    Chernivtsi

  • Study site

    Dnipro

  • Study site

    Donetsk

  • Study site

    Kharkiv

  • Study site

    Odesa

  • Study site

    Uzhhorod

Other trials in Ukraine

France5 sites

  • Study site

    Bordeaux

  • Study site

    Caen

  • Study site

    Pierre-Bénite

  • Study site

    Saint-Cloud

  • Study site

    Saint-Herblain

Other trials in France

Spain4 sites

  • Study site

    Barcelona

  • Study site

    Madrid

  • Study site

    Seville

  • Study site

    Valencia

Other trials in Spain

South Korea3 sites

  • Study site

    Busan

  • Study site

    Seoul

  • Study site

    Suwon

Other trials in South Korea

Ireland2 sites

  • Study site

    Galway

  • Study site

    Limerick

Other trials in Ireland

Luxembourg2 sites

  • Study site

    Luxembourg

  • Study site

    Niedercorn

Other trials in Luxembourg

Poland2 sites

  • Study site

    Bialystok

  • Study site

    Warsaw

Other trials in Poland

About this study

Official title: 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

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.

Read the detailed description

This is a randomized (study drug assigned by chance), open-label (all participants will know the identity of the assigned study drug) study divided into three phases, screening, treatment, and follow-up. During screening, potential patients will be assessed for study eligibility after providing signed informed consent. The treatment phase will comprise a series of 28-day cycles with continuous study treatment until breast cancer progression, when an end-of-treatment visit will be completed before the follow-up phase begins. The duration of participation in the study for an individual patient may be up to approximately 7 years, including follow-up evaluations. Patients will be evaluated for the safety and effectiveness of study treatments. During the treatment phase, patients will take the following study drugs by mouth once daily: abiraterone acetate, 1 g/day, as four 250-mg tablets, on an empty stomach, and patients must not eat for at least 1 hour after abiraterone acetate; prednisone (prednisolone when prednisone is not available), 5 mg/day; and exemestane, 25 mg/day, as a single tablet. The treatment phase will consist of a series of 28-day cycles with continuous study treatment until breast cancer progression. At the planned interim analysis, the Data Review Committee has recommended that further randomization to the abiraterone acetate alone group be stopped and that the study is to be continued otherwise.

Being tested
Exemestane, Abiraterone acetate + Prednisone/ Prednisolone + Exemestane, Abiraterone acetate + Prednisone or Prednisolone
Keywords
Breast cancer, Abiraterone, Postmenopausal, Metastatic
Medical subject headings
Breast Neoplasms, Neoplasm Metastasis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ExemestaneDrug

    Abiraterone acetate, type=equal, unit=mg, number=250, form=tablet, route=oral use, 4 tablets

  • Abiraterone acetate + Prednisone/ Prednisolone + ExemestaneDrug

    Prednisone or Prednisolone, type=equal, unit=mg, number=5, form=tablet, route=oral use. All drugs are taken once daily.

  • Abiraterone acetate + Prednisone or PrednisoloneDrug

    Abiraterone acetate, type=equal, unit=mg, number=250, form=tablet, route=oral use, 4 tablets

Study groups in NCT01381874
Study groupRoleWhat they receive
Abiraterone acetate + Prednisone or PrednisoloneExperimentalAbiraterone 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.
Receives: Drug: Abiraterone acetate + Prednisone or Prednisolone
Abiraterone acetate + Prednisone/Prednisolone + ExemestaneExperimentalAbiraterone 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.
Receives: Drug: Abiraterone acetate + Prednisone/ Prednisolone + Exemestane
ExemestaneExperimentalExemestane Exemestane type=equal unit=mg number=25 form=tablet route=oral use. All drugs are taken once daily.
Receives: Drug: Exemestane

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Approximately 2 years

  2. Overall Survival (OS)

    OS was calculated as the time from randomization to death from any cause.

    Measured: Approximately 3 years

Secondary outcomes (5)

  1. Overall Response Rate (ORR)

    Overall response rate was defined as the percentage of participants with measurable disease achieving a best overall response of either complete response (CR) or partial response (PR) based on RECIST. CR: disappearance of all target lesions and non-target lesions. PR: at least a 30 percent (%) decrease in the sum of longest diameter (LD) of target lesions or persistence of one or more non-target lesion(s) or/and maintenance of tumor marker level above the normal limits.

    Measured: Approximately 2 years

  2. Clinical Benefit Rate

    Clinical benefit rate was defined as the percentage of participants with measurable disease achieving a best overall response of a CR, PR, or stable disease (SD) for at least 6 months based on RECIST. Stable disease: neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD), taking as reference the smallest sum diameters while on study and persistence of one or more non-target lesion(s) and/or maintenance of tumour marker level above the normal limits.

    Measured: Approximately 2 years

  3. Duration of Response

    Duration of objective response was measured from the first time that the CR or PR was achieved to the first observation of disease progression (either radiographic or clinical) based on the RECIST criteria.

    Measured: Approximately 2 years

  4. Change From Baseline in Serum Endocrine Biomarkers (Estradiol and Estrone) at End of Treatment

    Change from baseline in serum endocrine biomarkers (estradiol and estrone) was summarized by treatment at end of treatment.

    Measured: Baseline and End of treatment (approximately 2 years)

  5. Change From Baseline in Serum Endocrine Biomarkers (Progesterone and Testosterone) at End of Treatment

    Change from baseline in serum endocrine biomarkers (Progesterone and Testosterone) was summarized by treatment at end of treatment.

    Measured: Baseline and End of treatment (approximately 2 years)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Jun 2011 (estimated)
  2. Study start24 Aug 2011
  3. Primary completion28 Jul 2014
  4. Study completion8 Aug 2018

Resources

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
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
297 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01381874
Sponsor's protocol ID
CR018286
Other IDs
212082BCA2001, 2011-000621-80
Status last verified
Mar 2019
First submitted
23 Jun 2011
Last updated
11 Apr 2019
Data monitoring committee
Yes
FDA-regulated device
No

Publications

  • 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.

    PubMed 26504153

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Exemestane, Abiraterone acetate + Prednisone/ Prednisolone + Exemestane and Abiraterone acetate + Prednisone or Prednisolone in people with Metastatic ER+ Her2- Breast Cancer and Postmenopausal, run by Janssen Research & Development, LLC at 81 sites in 12 countries.

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 6 inclusion and 6 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: finished, as of the sponsor's last update on 11 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 81 sites in United States, Belgium, Russia, United Kingdom, Netherlands and 7 more countries. 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?

Yes. Results are posted in the registry (first posted 27 Jul 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Progression-Free Survival (PFS) (time frame: Approximately 2 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01381874, which also lists 1 linked publication.

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 11 Apr 2019.

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