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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


Phase 2
18 Years
N/A
Open (Enrolling)
Female
Metastatic ER+ Her2- Breast Cancer, Postmenopausal

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Trial Information

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


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
3.5 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.


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.

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Progression free survival

Outcome Time Frame:

Up to approximately 1.5 years

Safety Issue:

No

Principal Investigator

Janssen Research & Development, LLC Clinical Trial

Investigator Role:

Study Director

Investigator Affiliation:

Janssen Research & Development, LLC

Authority:

United States: Food and Drug Administration

Study ID:

CR018286

NCT ID:

NCT01381874

Start Date:

August 2011

Completion Date:

July 2014

Related Keywords:

  • Metastatic ER+ Her2- Breast Cancer
  • Postmenopausal
  • Breast cancer
  • Abiraterone
  • Postmenopausal
  • Metastatic
  • Breast Neoplasms

Name

Location

Hinsdale, Illinois  60521
Fountain Valley, California  92708
Albany, New York  12208
Cleveland, Ohio  44195
Austin, Texas  78705
Seattle, Washington  98195
Flint, Michigan  48532
Scarborough, Maine  04074
Boston, Massachusetts  
Charlotte, North Carolina  
Eugene, Oregon  
Las Vegas, Nevada  89109
Sioux Falls, South Dakota  
Bismarck, North Dakota  58501