scholarly journals Phase Ib Dose-escalation/Expansion Trial of Ribociclib in Combination With Everolimus and Exemestane in Postmenopausal Women with HR+, HER2− Advanced Breast Cancer

2020 ◽  
Vol 26 (24) ◽  
pp. 6417-6428
Author(s):  
Aditya Bardia ◽  
Shanu Modi ◽  
Mafalda Oliveira ◽  
Javier Cortes ◽  
Mario Campone ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Advanced Breast Cancer ◽  
Postmenopausal Women ◽  
Dose Escalation ◽  
Advanced Breast ◽  
Phase Ib

PIKHER2: A phase Ib/II study evaluating safety and efficacy of oral BKM120 in combination with lapatinib in HER2-positive, PI3K-activated, trastuzumab-resistant advanced breast cancer.

2013 ◽  
Vol 31 (15_suppl) ◽  
pp. TPS663-TPS663 ◽  
Author(s):  
Anthony Goncalves ◽  
Nicolas Isambert ◽  
Mario Campone ◽  
Veronique Dieras ◽  
Jean Marie Boher ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Advanced Breast Cancer ◽  
Phase Ii ◽  
Dose Escalation ◽  
Objective Response ◽  
Mtor Pathway ◽  
Advanced Breast ◽  
Her2 Positive ◽  
Safety And Efficacy ◽  
Phase Ib

TPS663 Background: Phosphatidylinositol-3-kinase (PI3K)/AKT/mammalian target of rapamycin (mTOR)-pathway is frequently activated in HER2-positive breast cancer and may play a major role in resistance to trastuzumab. BKM120 is an oral pan-class I PI3K inhibitor with potent and selective activity against wild-type and mutant PI3K p110α. PIKHER2 study will evaluate safety and efficacy of oral, daily lapatinib-BKM120 combination in HER2-positive, trastuzumab-resistant advanced breast cancer (ABC) with activated PI3K/AKT/mTOR pathway. Methods: This open label, single arm, multi-center study includes a phase Ib dose-escalation part and a phase II expansion part at the recommended dose (RP2D). Primary objectives include determination of the maximum-tolerated dose (MTD) of BKM120 in combination with lapatinib in trastumuzab-resistant HER2-positive ABC (phase Ib part) and evaluation of the activity of BKM120-lapatinib combination at RP2D as measured by objective response rate (ORR) in patients with activated PI3K/AKT/mTOR pathway, as defined by PTEN-negative by IHC and/or somatic mutations (exons 9 and 20) of PIK3CA and/or overexpression of phospho-AKT by IHC (phase II part). Secondary objectives include safety and tolerability of the combination, clinical benefit and progression-free survival, pharmacokinetic profiles, biological and pharmacodynamic correlates. Main eligibility criteria are PS ≤ 1, HER2-positive ABC resistant to trastuzumab, documented activated PI3K/AKT/mTOR pathway (phase II part only). A modified CRM using an adaptive Bayesian model guides the dose escalation of both agents with a maximum of 24 patients planned to be enrolled in phase Ib part. Efficacy will be tested according to a standard 2-stage Simon design under the following unacceptable and desirable hypotheses: H0, ORR <= 10% (unacceptable rate) vs. H1, ORR >=30% (desirable rate). A maximum of 35 patients with activated PI3K/AKT/mTOR pathway is planned to be enrolled in phase II part with an interim look after 18 evaluable patients will have been recruited. Clinical trial information: NCT01589861.

Clinical Trial of Letrozole (femara) versus Aminoglutethimide in Postmenopausal Women with Advanced Breast Cancer

2005 ◽  
Vol 4 (6) ◽  
pp. 338-340
Author(s):  
Xiaoqing LIU ◽  
Santai SONG ◽  
Zefei JIANG ◽  
Weilian LI ◽  
Weixia WANG ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Clinical Trial ◽  
Advanced Breast Cancer ◽  
Postmenopausal Women ◽  
Advanced Breast
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