BELLE-2
Prior therapy with a PI3K, AKT or mTOR inhibitor,
or fulvestrant
>1 chemotherapy line for metastatic disease
Symptomatic CNS metastases
PHQ-9 score ≥12, or response of
"1, 2, or 3" to Question 9
GAD-7 mood scale score ≥15
Medical history of, or active major depressive episode,
bipolar disorder, obsessive-compulsive disorder,
schizophrenia, suicidal attempt or ideation, or homicidal
ideation, or active severe personality disorder
≥CTCAE grade 3 anxiety
History of cardiac disease or LVEF <50%
Current treatment with warfarin or other
coumarin-derived anti-coagulant
Current treatment with moderate or strong
inhibitors or inducers of CYP3A
Exclusion Criteria
Postmenopausal women with ER+ and/or PgR+
and HER2– inoperable locally advanced or
metastatic BC
Disease refractory to AI:
•
Recurrence during or ≤12 months from end of
adjuvant treatment with AI
•
Progression during or ≤1 month from end of AI
for locally advanced or mBC
Adequate tumor tissue for analysis of
PI3K-related biomarkers
Recurrence or progression on/after last systemic
therapy prior to enrollment
ECOG performance status ≤2
Laboratory values within normal range
Patient is able to swallow and retain oral
medication
AI, aromatase inhibitor; CNS, central nervous system;
CTCAE, Common Terminology Criteria for Adverse Events;
GAD-7, General Anxiety Disorder Assessment 7-item; LVEF, left ventricular ejection fraction;
PHQ-9, patient health questionnaire 9-item. * Refer to the protocol for a comprehensive list of inclusion/exclusion criteria.
1. BELLE-2 Study Protocol, version no. 03; 31-July-2014. NCT01610284/CBKM120F2302.
Inclusion Criteria
1
6
0
9
0
4
3
6
8
1
