Studieoverzicht - 2011-01 Abiraterone

Number 2011-01 Abiraterone
Nickname Abiraterone
Status Follow up Date: 30-04-2013
Inclusion closed
Other study number(s) JNJ-212082
Participating parties/groups
Full 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
Phase and type Randomized Phase II
Age ≥ 18
Menopausal status Postmenopausal
Indication Advanced/metastatic
Subindication HER2- HR+
Target sample size 300
Actual accrual 297 (NL: 21) Date: 14-05-2013
Estimated study completion date 01-03-2013
CCMO approval Yes Date: Nr: NL36667.029.11
EudraCT nr. 2011-000621-80
Trial Register NCT01381874
METC approval Yes Date: 14-11-2011 METC: Vrije Universiteit Medisch Centrum Nr: 2011/254
Amendments Yes Date: 04-11-2011
KWF-CKS approval Not applicable Date: Nr:
News item
Sponsor Janssen
Principal Investigator(s) Prof. dr. E. Boven (NL)
Study manager K. Beysen (Janssen)
A.E. van Leeuwen-Stok (BOOG Study Center)
Central datamanagement and randomization Janssen
Monitoring Janssen
Local datamanagement



  • Abiraterone acetate + Prednisone or Prednisolone
  • Abiraterone acetate + Prednisone/ Prednisolone + Exemestane
  • Exemestane

Abiraterone - Design 


Primary Objective
The primary objective is to assess the safety and efficacy of 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.


Primary Efficacy Endpoint
The primary efficacy endpoint, PFS, is measured from time of randomization to first occurrence
of one of the following:

  • Disease progression
  • Death from any cause

Secondary Efficacy Endpoints

  • Overall survival
  • Overall response to treatment
  • PROs: EORTC-C30, EQ-5D-5L, and BPI-SF pain intensity scale scores
  • Change in endocrine marker concentrations (estradiol, testosterone, estrone, and other biomarkers)
  • PK characterization of abiraterone and exemestane

Other efficacy endpoints include ECOG, pharmacogenomics evaluations, CTC characterization, and biomarker evaluations in fresh tumor biopsies.

Main eligibility criteria:

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.
Documents (public):

Protocol synopsis

Documents (protected):
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