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

Completed · Phase 2

Conditions studied: Metastatic ER+ Her2- Breast Cancer, Postmenopausal

In brief

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.

Key facts

Study ID

NCT01381874

Run by

Janssen Research & Development, LLC

People needed

297

Starts

2011-08-24

Expected to finish

2018-08-08

Last updated by the study team

2019-04-11

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

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

Where it is running

• Study site — Fresno, California, United States
• Study site — Los Angeles, California, United States
• Study site — Monterey, California, United States
• Study site — Chicago, Illinois, United States
• Study site — Waterville, Maine, United States
• Study site — Boston, Massachusetts, United States
• Study site — Ann Arbor, Michigan, United States
• Study site — Henderson, Nevada, United States
• Study site — East Syracuse, New York, United States
• Study site — Johnson City, New York, United States
• Study site — New York, New York, United States
• Study site — Durham, North Carolina, United States
• Study site — Fargo, North Dakota, United States
• Study site — Cleveland, Ohio, United States
• Study site — Columbus, Ohio, United States
• Study site — Kettering, Ohio, United States
• Study site — Portland, Oregon, United States
• Study site — Sioux Falls, South Dakota, United States
• Study site — Dallas, Texas, United States
• Study site — El Paso, Texas, United States
• Study site — Houston, Texas, United States
• Study site — Tyler, Texas, United States
• Study site — Seattle, Washington, United States
• Study site — Antwerp, Belgium
• Study site — Muscle Shoals, Alabama, United States

Full record on ClinicalTrials.gov

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