Breast Cancer Clinical Trial

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

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.

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Full 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.

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Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Study is for people with:

Breast Cancer

Phase:

Phase 2

Estimated Enrollment:

297

Study ID:

NCT01381874

Recruitment Status:

Completed

Sponsor:

Janssen Research & Development, LLC

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There is 1 Location for this study

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Muscle Shoals Alabama, , United States

Fresno California, , United States

Los Angeles California, , United States

Monterey California, , United States

Chicago Illinois, , United States

Waterville Maine, , United States

Boston Massachusetts, , United States

Ann Arbor Michigan, , United States

Henderson Nevada, , United States

East Syracuse New York, , United States

Johnson City New York, , United States

New York New York, , United States

Durham North Carolina, , United States

Fargo North Dakota, , United States

Cleveland Ohio, , United States

Columbus Ohio, , United States

Kettering Ohio, , United States

Portland Oregon, , United States

Sioux Falls South Dakota, , United States

Dallas Texas, , United States

El Paso Texas, , United States

Houston Texas, , United States

Tyler Texas, , United States

Seattle Washington, , United States

Antwerpen , , Belgium

Brussels , , Belgium

Brussel , , Belgium

Bruxelles , , Belgium

Duffel , , Belgium

Edegem , , Belgium

Gent , , Belgium

Hasselt , , Belgium

Leuven , , Belgium

Liège , , Belgium

Wilrijk , , Belgium

Bordeaux , , France

Caen Cedex 05 , , France

Pierre Benite , , France

Saint Herblain , , France

Saint-cloud , , France

Galway , , Ireland

Limerick , , Ireland

Busan , , Korea, Republic of

Seoul , , Korea, Republic of

Suwon , , Korea, Republic of

Luxembourg , , Luxembourg

Niederkorn , , Luxembourg

Alkmaar , , Netherlands

Amsterdam , , Netherlands

Heerlen , , Netherlands

Leeuwarden , , Netherlands

Leiden , , Netherlands

Rotterdam , , Netherlands

Sittard , , Netherlands

Bialystok , , Poland

Warszawa , , Poland

Chelyabinsk , , Russian Federation

Kazan , , Russian Federation

Leningrad Region , , Russian Federation

Moscow , , Russian Federation

Saint-Petersburg, , , Russian Federation

Sochi , , Russian Federation

St Petersburg , , Russian Federation

Stavropol , , Russian Federation

Vladimir , , Russian Federation

Barcelona , , Spain

Madrid N/a , , Spain

Madrid , , Spain

Sevilla , , Spain

Valencia , , Spain

Chernivtsi , , Ukraine

Dnepropetrovsk , , Ukraine

Donetsk , , Ukraine

Kharkov , , Ukraine

Odessa , , Ukraine

Tcherkassy , , Ukraine

Uzhgorod , , Ukraine

Bath , , United Kingdom

Birmingham , , United Kingdom

Exeter , , United Kingdom

London , , United Kingdom

Nottingham , , United Kingdom

Plymouth , , United Kingdom

Sheffield , , United Kingdom

Sutton , , United Kingdom

How clear is this clinincal trial information?

Study is for people with:

Breast Cancer

Phase:

Phase 2

Estimated Enrollment:

297

Study ID:

NCT01381874

Recruitment Status:

Completed

Sponsor:


Janssen Research & Development, LLC

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