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    Association details:
    Biomarker:HR positive
    Cancer:HER2 Negative Breast Cancer
    Drug:buparlisib (AN2025) (PI3K inhibitor)
    Direction:Sensitive
    Evidence:
    Evidence Level:
    Sensitive: B - Late Trials
    New
    Source:
    Lancet Oncol
    Title:

    Buparlisib plus fulvestrant versus placebo plus fulvestrant in postmenopausal, hormone receptor-positive, HER2-negative, advanced breast cancer (BELLE-2): a randomised, double-blind, placebo-controlled, phase 3 trial

    Excerpt:
    ...1147 patients from 267 centres in 29 countries were randomly assigned to receive buparlisib (n=576) or placebo plus fulvestrant (n=571)....In the total patient population (n=1147), median progression-free survival was 6·9 months (95% CI 6·8-7·8) in the buparlisib group versus 5·0 months (4·0-5·2) in the placebo group (hazard ratio [HR] 0·78 [95% CI 0·67-0·89]; one-sided p=0·00021)….The results from this study show that PI3K inhibition combined with endocrine therapy is effective in postmenopausal women with endocrine-resistant, hormone receptor-positive and HER2-negative advanced breast cancer.
    Secondary therapy:
    fulvestrant
    DOI:
    10.1016/S1470-2045(17)30376-5
    Trial ID:
    BELLE-2
    Evidence Level:
    Sensitive: C2 – Inclusion Criteria
    New
    Go to data
    Source:
    clinicaltrials.gov
    Title:

    Phase III Study of BKM120/Placebo With Fulvestrant in Postmenopausal Patients With Hormone Receptor Positive HER2-negative Locally Advanced or Metastatic Breast Cancer Refractory to Aromatase Inhibitor

    Excerpt:
    ...- HER2-negative and hormone receptor-positive status (common breast cancer classification tests)...
    Trial ID:
    BELLE-2
    Evidence Level:
    Sensitive: C2 – Inclusion Criteria
    New
    Source:
    clinicaltrials.gov
    Title:

    Trial of BKM120/Tamoxifen-combination in Patients With HR-pos, HER2-neg Breast Cancer

    Excerpt:
    ...- Patient has a known hormone receptor status HR-positive (ER and/or PR positive) and HER2-negative status...
    Trial ID:
    PIKTAM
    Less C2 evidence
    Evidence Level:
    Sensitive: C3 – Early Trials
    Source:
    Clin Cancer Res
    Title:

    A Phase Ib Study of Alpelisib or Buparlisib Combined with Tamoxifen Plus Goserelin in Premenopausal Women with HR-Positive HER2-Negative Advanced Breast Cancer

    Published date:
    01/15/2021
    Excerpt:
    This study enrolled premenopausal women with HR+, HER2- ABC. Patients received tamoxifen (20 mg once daily) and goserelin acetate (3.6 mg every 28 days) with either alpelisib (350 mg once daily; n = 16) or buparlisib (100 mg once daily; n = 13)...Progression-free survival was 25.2 months in the alpelisib group and 20.6 months in the buparlisib group.
    Secondary therapy:
    tamoxifen
    DOI:
    10.1158/1078-0432.CCR-20-1008
    Trial ID:
    B-YOND