Belle III

Eine  Phase III StudieDie Studie untersucht die Wirksamkeit und Sicherheit von BKM120 in Kombination mit Fulvestrant bei Patientinnen mit HER2-negativem und ER-positivem metastasierten Mammakarzinom, deren Erkrankung unter einer Therapie mit einem Aromataseinhibitor und einem mTOR-Inhibitor fortgeschritten ist.

A phase III randomized, double blind, placebo controlled study of BKM 120 with fulvestrant, in postmenopausal women with hormone receptor-positive HER2-negative Al treated,locally advanced or metastatic breast cancer who progressed on or after mTOR inhibitor based treatment.

Eligibility

Inclusion Criteria

• Postmenopausal adult women with HR+/HER2 , aromatase inhibitor-treated, inoperable locally advanced or metastatic breast cancer
• Evidence of progression on or after mTOR inhibitor-based treatment
• Adequate tumor tissue (archival or new tumor biopsy) for the analysis of PI3K-related biomarkers
• Measurable disease or nonmeasurable lytic or mixed (lytic and blastic) bone lesions (RECIST 1.1)
• ECOG PS of ≤2

Exclusion Criteria

• Previous treatment with a PI3K or AKT inhibitor, or fulvestrant
• More than one prior line of chemotherapy for metastatic disease
• Symptomatic central nervous system metastases
• Chronic or increasing treatment with corticosteroids or another immunosuppressive agent
• Active cardiac disease or a history of cardiac dysfunction
• Certain scores on patient self-reported mood questionnaires, or ≥CTCAE
  grade 3 anxiety