Studieoverzicht - 2011-01 Abiraterone

Arms:

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

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.

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.

Protocol synopsis