Evidence map›Paper›PMID 33602685›Full record

Trial reportClinical cancer research : an official journal of the American Association for Cancer Research2021

Clinical and Biomarker Results from Phase I/II Study of PI3K Inhibitor Alpelisib plus Nab-paclitaxel in HER2-Negative Metastatic Breast Cancer.

Priyanka Sharma, Vandana G Abramson, Anne O'Dea, Lauren Nye, Ingrid Mayer, Harsh B Pathak, Marc Hoffmann, Shane R Stecklein, Manana Elia, Sharon Lewis and 14 more

Registry-linked trialOpen access · bronzeAbstract readClinical Trial, Phase IClinical Trial, Phase II
In one paragraph

Trial report in Clinical cancer research : an official journal of the American Association for Cancer Research, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02379247 (Phase I/II Study of BYL719 and Nab-Paclitaxel in Subjects With Locally Recurrent or Metastatic HER-2 Negative Breast Cancer), which is not on this map. Cited by 52 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
52citing papers in PubMed, 2 pooled it
5.4field-weighted citation impact, top 3% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT02379247 phase1 / phase2completednot on this map

Phase I/II Study of BYL719 and Nab-Paclitaxel in Subjects With Locally Recurrent or Metastatic HER-2 Negative Breast Cancer

TypeinterventionalSponsorPriyanka SharmaRan2015 to 2022Enrolled43ConditionsBreast CancerArmsBYL-719 (alpelisib), Nab-paclitaxel
3 · Its place in the literature

Who cites it

52 citing papers in PubMed, 2 syntheses or guidelines pooled it, 83 citations in OpenAlex.

  1. Pooled it
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  12. Breast cancer: pathogenesis and treatments.Signal transduction and targeted therapy · 2025
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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

24 authors at 3 institutions in 1 country.

Priyanka SharmaDepartment of Internal Medicine, University of Kansas Medical Center, Westwood, Kansas. psharma2@kumc.edu.
Vandana G AbramsonVanderbilt-Ingram Cancer Center, Vanderbilt University Medical Center, Nashville, Tennessee.ORCID 0000-0002-6855-1322
Anne O'DeaDepartment of Internal Medicine, University of Kansas Medical Center, Westwood, Kansas.
Lauren NyeDepartment of Internal Medicine, University of Kansas Medical Center, Westwood, Kansas.ORCID 0000-0001-6921-0987
Ingrid MayerVanderbilt-Ingram Cancer Center, Vanderbilt University Medical Center, Nashville, Tennessee.
Harsh B PathakDepartment of Pathology & Laboratory Medicine, University of Kansas Medical Center, Kansas City, Kansas.
Marc HoffmannDepartment of Internal Medicine, University of Kansas Medical Center, Westwood, Kansas.
Shane R SteckleinDepartment of Radiation Oncology, University of Kansas Medical Center, Kansas City, Kansas.
Manana EliaDepartment of Internal Medicine, University of Kansas Medical Center, Westwood, Kansas.
Sharon LewisClinical Research Center, University of Kansas Medical Center, Fairway, Kansas.
Jecinta ScottClinical Trials Shared Resource, University of Kansas Medical Center, Fairway, Kansas.
Jilliann A De JongClinical Trials Shared Resource, University of Kansas Medical Center, Fairway, Kansas.
Yen Y WangUniversity of Kansas Cancer Center, Kansas City, Kansas.
Rachel YoderUniversity of Kansas Cancer Center, Kansas City, Kansas.
Kelsey SchwensenDepartment of Internal Medicine, University of Kansas Medical Center, Westwood, Kansas.
Karissa FinkeUniversity of Kansas Cancer Center, Kansas City, Kansas.
Jaimie HeldstabUniversity of Kansas Cancer Center, Kansas City, Kansas.
Stephanie LaFaverUniversity of Kansas Cancer Center, Kansas City, Kansas.
Stephen K WilliamsonDepartment of Internal Medicine, University of Kansas Medical Center, Westwood, Kansas.ORCID 0000-0003-4118-1242
Milind A PhadnisDepartment of Biostatistics & Data Science, University of Kansas Medical Center, Kansas City, Kansas.ORCID 0000-0001-6472-9325
Gregory A ReedUniversity of Kansas Cancer Center, Kansas City, Kansas.
Bruce F KimlerDepartment of Radiation Oncology, University of Kansas Medical Center, Kansas City, Kansas.ORCID 0000-0001-7021-6964
Qamar J KhanDepartment of Internal Medicine, University of Kansas Medical Center, Westwood, Kansas.
Andrew K GodwinDepartment of Pathology & Laboratory Medicine, University of Kansas Medical Center, Kansas City, Kansas.ORCID 0000-0002-3987-9580
University of Kansas Medical Center · USThe University of Kansas Cancer Center · USVanderbilt University Medical Center · US

Funding

TISSUE CoreP50CA098131 · NCI · VANDERBILT UNIVERSITY MEDICAL CENTER · PI PARK, BEN HO, PIETENPOL, JENNIFER A · 2003 to 2024
$48.7M
Transgenic & Gene-Targeting Shared ResourceP30CA168524 · NCI · UNIVERSITY OF KANSAS MEDICAL CENTER · PI ROY A. JENSEN · 2012 to 2026
$40.1M
Using Integrated Omics to Identify Dysfunctional Genetic Mechanisms Influencing Schizophrenia and Sleep DisturbancesP20GM130423 · NIGMS · UNIVERSITY OF KANSAS MEDICAL CENTER · PI Diane E Mahoney · 2019 to 2026
$21.5M
Institutional Career Development CoreKL2TR002367 · NCATS · UNIVERSITY OF KANSAS MEDICAL CENTER · PI MATTHEW W MOSCONI, NICOLE L NOLLEN · 2017 to 2026
$7.3M
NCATS NIH HHS KL2 TR002367NCI NIH HHS P30 CA168524NCI NIH HHS P50 CA098131NIGMS NIH HHS P20 GM130423
6 · The paper itself

Abstract

purposePATIENTS AND

methodsEligible patients had HER2-negative MBC with any number of prior chemotherapies. Phase I was 3+3 dose-escalation design with three dose levels of alpelisib (250, 300, and 350 mg) daily plus nab-paclitaxel 100 mg/m

resultsA total of 43 patients were enrolled (phase I,

conclusionsThe alpelisib plus nab-paclitaxel combination was well tolerated and shows encouraging efficacy, especially in patients with

Indexed as

MutationAdultAgedAlbuminsBiomarkers, TumorBreast NeoplasmsClass I Phosphatidylinositol 3-KinasesDrug CombinationsErb-b2 Receptor Tyrosine KinasesFemaleHumansMiddle AgedNeoplasm MetastasisPaclitaxelThiazoles130-nm albumin-bound paclitaxelAlbuminsAlpelisibBiomarkers, TumorClass I Phosphatidylinositol 3-KinasesDrug CombinationsErb-b2 Receptor Tyrosine KinasesPaclitaxelPIK3CA protein, humanThiazoles

Identifiers

PMID33602685
PMCPMC8282704
OpenAlexW3131053290

What Socratic holds

Textmetadata
LicenceTDM
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the Socratic graph.