BKM120 matching placebo

DRUG3 trials

Sponsors

Novartis Pharmaceuticals

Conditions

Breast CancerMetastatic Breast Cancer

Phase 2

A Study of the Experimental Drug BKM120 With Paclitaxel in Patients With HER2 Negative, Locally Advanced or Metastatic Breast Cancer, With or Without PI3K Activation

CompletedNCT01572727

Novartis PharmaceuticalsBreast Cancer

Start: 2012-08-31End: 2015-06-30Updated: 2017-03-09

Phase 3

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

CompletedNCT01610284

Novartis PharmaceuticalsBreast Cancer

Start: 2012-08-07End: 2019-04-19Updated: 2020-08-25

A Phase III Study of BKM120 With Fulvestrant in Patients With HR+,HER2-, AI Treated, Locally Advanced or Metastatic Breast Cancer Who Progressed on or After mTORi

TerminatedNCT01633060

Novartis PharmaceuticalsMetastatic Breast Cancer

Start: 2012-10-03End: 2017-09-21Updated: 2019-01-30

Related Papers

PI3K inhibitor provides durable response in metastatic metaplastic carcinoma of the breast: A hidden gem in the BELLE-4 study

Journal of the Formosan Medical Association2018-12-1827 citations

Buparlisib plus fulvestrant versus placebo plus fulvestrant for postmenopausal, hormone receptor-positive, human epidermal growth factor receptor 2-negative, advanced breast cancer: Overall survival results from BELLE-2.

2018-09-1847 citations

A phase Ib study of pictilisib (GDC-0941) in combination with paclitaxel, with and without bevacizumab or trastuzumab, and with letrozole in advanced breast cancer.

2018-09-0556 citations

Abstract PD5-12: Buparlisib (BUP) or placebo (PBO) plus fulvestrant (FUL) in postmenopausal patients (pts) with hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2–) advanced breast cancer (ABC): Overall survival (OS) results from BELLE-2, a randomized, phase III study

Cancer Research2018-02-151 citations

Abstract A050: <i>PIK3CA</i> mutation status in tumor tissue and ctDNA as a biomarker for PFS in patients with HR+, HER2- ABC treated with buparlisib or placebo plus fulvestrant: results from the BELLE-2 and BELLE-3 randomized studies

Molecular Cancer Therapeutics2018-01-015 citations

Buparlisib plus fulvestrant in postmenopausal women with hormone-receptor-positive, HER2-negative, advanced breast cancer progressing on or after mTOR inhibition (BELLE-3): a randomised, double-blind, placebo-controlled, phase 3 trial.

2017-12-07297 citations

Abstract CT010: Efficacy results based on <i>PIK3CA</i> status in BELLE-3: A Phase 3 study of buparlisib (BKM120) + fulvestrant in postmenopausal women with aromatase inhibitor-treated, HR+/HER2- ABC after progression on an mTOR inhibitor

Cancer Research2017-07-01

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.

2017-05-30408 citations

Abstract S6-01: <i>PIK3CA</i> status in circulating tumor DNA (ctDNA) predicts efficacy of buparlisib (BUP) plus fulvestrant (FULV) in postmenopausal women with endocrine-resistant HR+/HER2– advanced breast cancer (BC): First results from the randomized, phase III BELLE-2 trial

Cancer Research2016-02-1588 citations

Abstract A166: BELLE-4: A Phase II study of buparlisib and paclitaxel in women with HER2- advanced breast cancer, with or without PI3K pathway activation

Molecular Cancer Therapeutics2015-12-011 citations

Abstract OT2-6-07: Buparlisib (BKM120), an oral pan-PI3K inhibitor, in combination with paclitaxel in patients with HER2-negative, locally advanced or metastatic breast cancer, with or without PI3K pathway activation: A phase II, randomized, double-blind, placebo-controlled study – BELLE-4

Cancer Research2013-12-153 citations