Randomized, Open-Label Study of Abiraterone Acetate (JNJ 212082) plus Prednisone/ Prednisolone with or without Exemestane in Postmenopausal Women with ER+ Metastatic Breast Cancer Progressing after Letrozole or Anastrozole Therapy

• Register: EUCTR
• Last refreshed on: 23 May 2016
• Main ID: EUCTR2011-000621-80-ES
• Date of registration: 13/06/2011
• Prospective Registration: Yes
• Primary sponsor: Janssen-Cilag International NV
• Public title: Randomized, Open-Label Study of Abiraterone Acetate (JNJ 212082) plus Prednisone/ Prednisolone with or without Exemestane in Postmenopausal Women with ER+ Metastatic Breast Cancer Progressing after Letrozole or Anastrozole Therapy
• Scientific title: Randomized, Open-Label Study of Abiraterone Acetate (JNJ 212082) plus Prednisone/ Prednisolone with or without Exemestane in Postmenopausal Women with ER+ Metastatic Breast Cancer Progressing after Letrozole or Anastrozole Therapy
• Date of first enrolment: 27/07/2011
• 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, 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:
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 1
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 1

Exclusion criteria:


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: 13.1 Level: LLT Classification code 10027475 Term: Metastatic breast cancer System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Intervention(s)

Product Name: Acetato de Abiraterona
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: Prednisolona
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: Exemestano
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:

Primary end point(s):

Secondary Objective:

Secondary ID(s)

2011-000621-80-BE

212082BCA2001

Source(s) of Monetary Support

Janssen Research & Development