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Clinical Trial
. 2016 Nov;27(11):2059-2066.
doi: 10.1093/annonc/mdw320. Epub 2016 Aug 29.

Pictilisib PI3Kinase inhibitor (a phosphatidylinositol 3-kinase [PI3K] inhibitor) plus paclitaxel for the treatment of hormone receptor-positive, HER2-negative, locally recurrent, or metastatic breast cancer: interim analysis of the multicentre, placebo-controlled, phase II randomised PEGGY study

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Clinical Trial

Pictilisib PI3Kinase inhibitor (a phosphatidylinositol 3-kinase [PI3K] inhibitor) plus paclitaxel for the treatment of hormone receptor-positive, HER2-negative, locally recurrent, or metastatic breast cancer: interim analysis of the multicentre, placebo-controlled, phase II randomised PEGGY study (VSports最新版本)

P Vuylsteke et al. Ann Oncol. 2016 Nov.
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Abstract

Background: Approximately 40% of hormone receptor-positive, HER2-negative breast cancers (BCs) are associated with activating mutations of the phosphatidylinositol 3-kinase (PI3K) pathway VSports手机版. Pictilisib, a potent and highly specific class I pan-PI3K inhibitor, demonstrated preclinical activity in BC cell lines and may potentiate the effect of taxanes, benefiting patients with or without aberrant activation of the PI3K pathway. PEGGY (NCT01740336), a randomised, placebo-controlled phase II trial, examined whether pictilisib augments the anti-tumour activity of paclitaxel in patients with hormone receptor-positive, HER2-negative locally recurrent or metastatic BC (mBC). We report results from the protocol-specified interim analysis. .

Patients and methods: One hundred and eighty-three eligible patients were randomised (1:1) to receive paclitaxel (90 mg/m2 weekly for 3 weeks in every 28-day cycle) with either 260 mg pictilisib or placebo (daily on days 1-5 every week). The primary end point was progression-free survival (PFS) in the intention-to-treat (ITT) population and patients with PIK3CA-mutated tumours. Secondary end points included overall response rate (ORR), duration of response, and safety V体育安卓版. .

Results: In the ITT population, the median PFS was 8. 2 months with pictilisib (n = 91) versus 7. 8 months with placebo (n = 92) [hazard ratio (HR) for progression or death, 0 V体育ios版. 95; 95% confidence interval (CI) 0. 62-1. 46; P = 0. 83]. In patients with PIK3CA-mutated tumours, the median PFS was 7. 3 months for pictilisib (n = 32) versus 5. 8 months with placebo (n = 30) (HR, 1. 06; 95% CI 0. 52-2. 12; P = 0. 88). ORR was similar between treatment arms. The safety profile of pictilisib was consistent with previous reports, with no new safety signals. Proportions of patients with grade ≥3 adverse events (AEs), serious AEs, and dose reductions/discontinuations due to AEs were higher with pictilisib. .

Conclusions: PEGGY did not meet its primary end point, revealing no significant benefit from adding pictilisib to paclitaxel for patients with hormone receptor-positive, HER2-negative locally recurrent or mBC. VSports最新版本.

Clinical trial number: NCT01740336. V体育平台登录.

Keywords: HER2-negative; PI3K; PIK3CA; hormone receptor-positive; metastatic breast cancer; pictilisib VSports注册入口. .

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