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
- Conditions
- Metastatic Breast CancerMedDRA version: 14.1 Level: LLT Classification code 10027475 Term: Metastatic breast cancer System Organ Class: 100000004864Therapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2011-000621-80-GB
- Lead Sponsor
- Janssen-Cilag International NV
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Not specified
- Target Recruitment
- 297
- Women patients must be postmenopausal
- ER+, Human epidermal growth factor receptor 2 (Her2) 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 one or less
-Clinical laboratory values during Screening:
- Clinically normal prothrombin time (PT) or international normalized ratio (INR) and partial thromboplastin time (PTT) per investigator assessment.
Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 250
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 50
- Prior treatment with exemestane, ketoconazole, aminoglutethimide, or a CYP17 inhibitor. Prior treatment with Prior treatment with exemestane, ketoconazole, aminoglutethimide, or a CYP17 inhibitor
- 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 & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method