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
Condition: Metastatic ER+ Her2- Breast Cancer; Postmenopausal
MeSH terms: Breast Neoplasms
Intervention: Exemestane; Abiraterone acetate + Prednisone/ Prednisolone + Exemestane; Abiraterone acetate + Prednisone or Prednisolone
Intervention description: Abiraterone acetate, type=equal, unit=mg, number=250, form=tablet, route=oral use, 4 tablets; Prednisone or Prednisolone, type=equal, unit=mg, number=5, form=tablet, route=oral use. All drugs are taken once daily.; Abiraterone acetate, type=equal, unit=mg, number=250, form=tablet, route=oral use, 4 tablets
Intervention MeSH terms: Prednisone; Prednisolone; Methylprednisolone Acetate; Methylprednisolone; Methylprednisolone Hemisuccinate; Prednisolone acetate; Exemestane; Abiraterone Acetate; Prednisolone hemisuccinate; Prednisolone phosphate
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 297.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Breast cancer; Abiraterone; Postmenopausal; Metastatic

Summary:

      The purpose of this study is to assess the safety and efficacy of oral abiraterone acetate
      plus oral prednisone and oral abiraterone acetate plus oral prednisone plus oral exemestane,
      each compared with oral exemestane alone, in postmenopausal women with estrogen
      receptor-positive (ER+) metastatic (spreading) breast cancer that has relapsed after
      treatment with letrozole or anastrozole.
    

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