Metastatic Breast Cancer MedDRA version: 18.0 Level: LLT Classification code 10027475 Term: Metastatic breast cancer System Organ Class: 100000004864
Conditions
Interventions
Trade Name: ZYTIGA
Product Name: Abiraterone acetate
Product Code: JNJ-212082
Pharmaceutical Form: Tablet
INN or Proposed INN: Abiraterone acetate
CAS Number: 154229-18-2
Current Sponsor code: JNJ-212
Sponsors
Janssen-Cilag International NV
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - 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 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
Exclusion criteria
Exclusion criteria: - 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective is to assess safety and efficacy of abiraterone acetate plus prednisone and abiraterone acetate plus prednisone plus exemestane, each compared with exemestane alone, in postmenopausal women with ER+ metastatic breast cancer progressing after letrozole or anastrozole therapy.;Secondary Objective: Secondary objectives are to assess abiraterone acetate plus prednisone and abiraterone acetate plus prednisone combined with exemestane, each compared with exemestane alone, in postmenopausal women with ER+ metastatic breast cancer progressing after letrozole or anastrozole therapy, with respect to the following: •Overall survival •Overall response rate •Patient-reported outcomes (PROs) EORTC-C30, EQ-5D-5L, and BPI-SF pain intensity scale •Endocrine markers estradiol, testosterone, estrone, and other biomarkers •PK characterization of abiraterone and exemestane;Primary end point(s): Progression free survivial ;Timepoint(s) of evaluation of this end point: Up to approximately 1.5 years | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1. Overall survival 2. Overall response rate to treatment 3. Patient-reported outcomes 4. Pharmacodynamics 5. Pharmacokinetics ;Timepoint(s) of evaluation of this end point: 1. Up to approximately 3.5 years 2. Up to 1.5 years 3. Up to approximately 3.5 years 4. Up to approximately 1.5 years 5. Approximately 4 months | — |
Countries
Belgium, France, Ireland, Italy, Korea, Republic of, Luxembourg, Netherlands, Poland, Russian Federation, Spain, Ukraine, United Kingdom, United States
Contacts
Public ContactClinical Registry Group
Janssen-Cilag International NV
Outcome results
None listed