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

• Register: EUCTR
• Last refreshed on: 28 August 2017
• Main ID: EUCTR2011-000621-80-BE
• Date of registration: 06/06/2011
• Prospective Registration: Yes
• Primary sponsor: Janssen-Cilag International NV
• Public title: 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
• Scientific title: 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
• Date of first enrolment: 01/08/2011
• Target sample size: 300
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2011-000621-80
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes Randomised: yes Open: yes Single blind: no Double blind: no Parallel group: yes Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: yes Placebo: no Other: no Number of treatment arms in the trial: 3
• Phase: Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): yes Therapeutic confirmatory - (Phase III): no Therapeutic use (Phase IV): no

Countries of recruitment

Belgium, France, Ireland, Italy, Korea, Republic of, Luxembourg, Netherlands, Poland, Russian Federation, Spain, Ukraine, United Kingdom, United States

Contacts

• Name: Clinical Registry Group
• Affiliation: Janssen-Cilag International NV

• Name: Clinical Registry Group
• Affiliation: Janssen-Cilag International NV

Key inclusion & exclusion 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:
- 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.


Age minimum:
Age maximum:
Gender:
Female: yes
Male: no

Health Condition(s) or Problem(s) studied

Therapeutic area: Diseases [C] - Cancer [C04]

Metastatic Breast Cancer
MedDRA version: 18.0 Level: LLT Classification code 10027475 Term: Metastatic breast cancer System Organ Class: 100000004864

Intervention(s)

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-212082
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 250-

Product Name: Prednisolone
Pharmaceutical Form: Tablet
INN or Proposed INN: Prednisolone
CAS Number: 50-24-8
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 5-

Product Name: exemestane
Pharmaceutical Form: Coated tablet
INN or Proposed INN: EXEMESTANE
CAS Number: 107868-30-4
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 25-

Primary Outcome(s)

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 Outcome(s)

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

Secondary end point(s): 1. Overall survival
2. Overall response rate to treatment
3. Patient-reported outcomes
4. Pharmacodynamics
5. Pharmacokinetics

Secondary ID(s)

212082BCA2001

Source(s) of Monetary Support

Janssen Research & Development, LLC