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A phase 1 trial of BKM120 (Buparlisib) in combination with fulvestrant in postmenopausal women with estrogen receptor positive metastatic breast cancer.

Overview of attention for article published in Clinical Cancer Research, November 2015
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Title
A phase 1 trial of BKM120 (Buparlisib) in combination with fulvestrant in postmenopausal women with estrogen receptor positive metastatic breast cancer.
Published in
Clinical Cancer Research, November 2015
DOI 10.1158/1078-0432.ccr-15-1745
Pubmed ID
Authors

Cynthia X Ma, Jingqin Luo, Michael Naughton, Foluso O Ademuyiwa, Rama Suresh, Malachi Griffith, Obi L Griffith, Zachary Skidmore, Nicholas C Spies, Avinash Ramu, Lee Trani, Timothy Pluard, Gayathri Nagaraj, Shana N Thomas, Zhanfang Guo, Jeremy Hoog, Jing Han, Elaine R Mardis, A. Craig Lockhart, Matthew J. Ellis

Abstract

This trial was conducted to determine the maximum tolerated dose (MTD) and preliminary efficacy of buparlisib, an oral pan-class I PI3K inhibitor, plus fulvestrant in postmenopausal women with metastatic estrogen receptor positive breast cancer (ER+BC). Phase IA employed a 3+3 design to determine the MTD of buparlisib daily plus fulvestrant. Subsequent cohorts evaluated intermittent (5 of 7 day dosing) and continuous buparlisib (100mg daily). No more than 3 prior systemic treatments in the metastatic setting were allowed in Phase IB and Cohort C. Thirty one patients were enrolled. MTD was defined as buparlisib 100mg daily plus fulvestrant. Common adverse events (AEs) included fatigue (38.7 %), transaminases elevation (35.5 %), rash (29%), and diarrhea (19.4%). C-peptide was significantly increased during treatment, consistent with on-target effect of buparlisib. Compared to intermittent dosing, daily buparlisib was associated with more frequent early onset AEs and higher buparlisib plasma concentrations. Among the 29 evaluable patients, the clinical benefit rate was 58.6% (95% CI 40.7-74.5%). Response was not associated with PIK3CA mutation or treatment cohort, however loss of PTEN, progesterone receptor (PgR) expression, or mutation in TP53 was commoner in resistant cases and mutations in AKT1 and ESR1 did not exclude treatment response. Buparlisib plus fulvestrant is clinically active with manageable AEs in patients with metastatic ER+BC. Weekend breaks in buparlisib dosing reduced toxicity. Patients with PgR negative and TP53 mutation did poorly, suggesting buparlisib plus fulvestrant may not be adequately effective against tumors with these poor prognostic molecular features.

Twitter Demographics

The data shown below were collected from the profiles of 2 tweeters who shared this research output. Click here to find out more about how the information was compiled.

Mendeley readers

The data shown below were compiled from readership statistics for 25 Mendeley readers of this research output. Click here to see the associated Mendeley record.

Geographical breakdown

Country Count As %
Australia 1 4%
France 1 4%
United Kingdom 1 4%
Unknown 22 88%

Demographic breakdown

Readers by professional status Count As %
Student > Master 6 24%
Student > Ph. D. Student 5 20%
Student > Postgraduate 4 16%
Researcher 4 16%
Other 2 8%
Other 4 16%
Readers by discipline Count As %
Medicine and Dentistry 13 52%
Agricultural and Biological Sciences 6 24%
Biochemistry, Genetics and Molecular Biology 2 8%
Arts and Humanities 1 4%
Pharmacology, Toxicology and Pharmaceutical Science 1 4%
Other 2 8%

Attention Score in Context

This research output has an Altmetric Attention Score of 1. This is our high-level measure of the quality and quantity of online attention that it has received. This Attention Score, as well as the ranking and number of research outputs shown below, was calculated when the research output was last mentioned on 14 November 2015.
All research outputs
#4,856,766
of 6,566,187 outputs
Outputs from Clinical Cancer Research
#3,764
of 4,728 outputs
Outputs of similar age
#143,036
of 208,433 outputs
Outputs of similar age from Clinical Cancer Research
#161
of 186 outputs
Altmetric has tracked 6,566,187 research outputs across all sources so far. This one is in the 14th percentile – i.e., 14% of other outputs scored the same or lower than it.
So far Altmetric has tracked 4,728 research outputs from this source. They receive a mean Attention Score of 5.0. This one is in the 13th percentile – i.e., 13% of its peers scored the same or lower than it.
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We're also able to compare this research output to 186 others from the same source and published within six weeks on either side of this one. This one is in the 7th percentile – i.e., 7% of its contemporaries scored the same or lower than it.