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.
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.
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
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There is 1 Location for this study
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
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