Evidence map›Paper›PMID 39217059›Full record

ArticleClinical breast cancer2024

A Phase I Trial of Alpelisib Combined With Capecitabine in Patients With HER2-Negative Metastatic Breast Cancer.

Danielle M File, Yara Abdou, Jeremy Force, Dominic T Moore, Carey K Anders, Katherine Reeder-Hayes, Lisa A Carey, Hyman B Muss, Charles M Perou, P Kelly Marcom and 1 more

Abstract readClinical Trial, Phase I
PubMed Full text at PMC Publisher
In one paragraph

Article in Clinical breast cancer, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
–field-weighted citation impact
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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

1 citing paper in PubMed.

  1. Article
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

11 authors.

Danielle M FileDepartment of Medical Oncology, The University of North Carolina at Chapel Hill, Chapel Hill, NC.
Yara AbdouDepartment of Medical Oncology, The University of North Carolina at Chapel Hill, Chapel Hill, NC; Lineberger Comprehensive Cancer Center, Chapel Hill, NC. Electronic address: Yara_Abdou@med.unc.edu.
Jeremy ForceDepartment of Medicine, Duke University, Durham, NC; Duke Cancer Institute, Durham, NC.
Dominic T MooreLineberger Comprehensive Cancer Center, Chapel Hill, NC.
Carey K AndersDepartment of Medicine, Duke University, Durham, NC; Duke Cancer Institute, Durham, NC.
Katherine Reeder-HayesDepartment of Medical Oncology, The University of North Carolina at Chapel Hill, Chapel Hill, NC; Lineberger Comprehensive Cancer Center, Chapel Hill, NC.
Lisa A CareyDepartment of Medical Oncology, The University of North Carolina at Chapel Hill, Chapel Hill, NC; Lineberger Comprehensive Cancer Center, Chapel Hill, NC.
Hyman B MussDepartment of Medical Oncology, The University of North Carolina at Chapel Hill, Chapel Hill, NC; Lineberger Comprehensive Cancer Center, Chapel Hill, NC.
Charles M PerouDepartment of Medical Oncology, The University of North Carolina at Chapel Hill, Chapel Hill, NC; Lineberger Comprehensive Cancer Center, Chapel Hill, NC; Department of Genetics, The University of North Carolina, Chapel Hill, NC.
P Kelly MarcomDepartment of Medicine, Duke University, Durham, NC; Duke Cancer Institute, Durham, NC.
E Claire DeesDepartment of Medical Oncology, The University of North Carolina at Chapel Hill, Chapel Hill, NC; Lineberger Comprehensive Cancer Center, Chapel Hill, NC.

Funding

Tissue Procurement & PathologyP50CA058223 · NCI · UNIV OF NORTH CAROLINA CHAPEL HILL · PI CHARLES M PEROU · 1992 to 2026
$59.3M
NCI NIH HHS P50 CA058223
6 · The paper itself

Abstract

backgroundAlpelisib is an oral α-specific class I PI3K inhibitor approved in combination with fulvestrant for the treatment of PIK3CA-mutated hormone receptor-positive (HR+), human epidermal growth factor receptor 2 negative (HER2-) metastatic breast cancer. The tolerability of this drug with the oral chemotherapy capecitabine is unknown. PATIENTS AND

methodsThis phase I trial evaluated the dose-limiting toxicities (DLTs) and maximum tolerated dose (MTD) of alpelisib (250 mg or 300 mg daily for 3-weeks) with capecitabine (1000 mg/m

resultsEighteen patients were treated with alpelisib-capecitabine. Half of the patients had HR+ breast cancer, and 16 had prior systemic therapy for metastatic disease. The MTD of alpelisib was 250 mg daily in combination with capecitabine 1000 mg/m

conclusionThis study provides safety data for an oral combination therapy of alpelisib-capecitabine and defines tolerable doses for further study.

Indexed as

Antineoplastic Combined Chemotherapy ProtocolsBreast NeoplasmsCapecitabineErb-b2 Receptor Tyrosine KinasesMaximum Tolerated DoseAdultAgedClass I Phosphatidylinositol 3-KinasesFemaleHumansMiddle AgedQuinazolinesThiazolesAlpelisibCapecitabineClass I Phosphatidylinositol 3-KinasesERBB2 protein, humanErb-b2 Receptor Tyrosine KinasesPIK3CA protein, humanQuinazolinesThiazolesAlpelisibBreast cancerCapecitabinePI3KPIK3CA

Identifiers

PMID39217059
PMCPMC11840667

What Socratic holds

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Registered trials

None linked

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.