Evidence map›Paper›PMID 39110531›Full record

Trial reportJournal of the National Cancer Institute2024

Drug and biomarker tissue levels in a randomized presurgical trial on exemestane alternative schedules.

Davide Serrano, Harriet Johansson, Bjørn-Erik Bertelsen, Sara Gandini, Gunnar Mellgren, Parijatham Thomas, Katherine D Crew, Nagi B Kumar, Debora Macis, Valentina Aristarco and 14 more

Erratum issued Registry-linked trialAbstract readRandomized Controlled Trial
In one paragraph

Trial report in Journal of the National Cancer Institute, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. It is linked to trial NCT02598557 (Alternative Dosing of Exemestane in Postmenopausal Women With Stage 0-II ER-Positive Breast Cancer), which is not on this 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.

NCT02598557 phase2completednot on this map

Alternative Dosing of Exemestane in Postmenopausal Women With Stage 0-II ER-Positive Breast Cancer: A Randomized Presurgical Trial

TypeinterventionalSponsorNational Cancer Institute (NCI)Ran2016 to 2023Enrolled180ConditionsStage 0 Breast Cancer AJCC v6 and v7, Stage I Breast Cancer AJCC v7, Stage IA Breast Cancer AJCC v7, Stage IB Breast Cancer AJCC v7ArmsExemestane, Laboratory Biomarker Analysis, Pharmacological Study, Placebo Administration, Quality-of-Life Assessment
3 · Its place in the literature

Who cites it

1 citing paper in PubMed.

  1. Article
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

24 authors.

Davide SerranoDivision of Cancer Prevention and Genetics, European Institute of Oncology IRCCS, Milan, Italy.ORCID 0000-0002-2945-4108
Harriet JohanssonDivision of Cancer Prevention and Genetics, European Institute of Oncology IRCCS, Milan, Italy.
Bjørn-Erik BertelsenHormone Laboratory, Department of Medical Biochemistry and Pharmacology, Haukeland University Hospital, Bergen, Norway.ORCID 0000-0001-8455-2176
Sara GandiniDivision of Cancer Prevention and Genetics, European Institute of Oncology IRCCS, Milan, Italy.
Gunnar MellgrenHormone Laboratory, Department of Medical Biochemistry and Pharmacology, Haukeland University Hospital, Bergen, Norway.
Parijatham ThomasDepartment of Clinical Cancer Prevention, University of Texas, MD Anderson Cancer Center, Houston, TX, USA.
Katherine D CrewClinical Breast Cancer Prevention Program, Columbia University Irving Medical Center, New York, NY, USA.
Nagi B KumarDepartments Cancer Epidemiology, Genitourinary and Breast Oncology, Moffitt Cancer Center, University of South Florida, Tampa, FL, USA.
Debora MacisDivision of Cancer Prevention and Genetics, European Institute of Oncology IRCCS, Milan, Italy.
Valentina AristarcoDivision of Cancer Prevention and Genetics, European Institute of Oncology IRCCS, Milan, Italy.
Aliana Guerrieri-GonzagaDivision of Cancer Prevention and Genetics, European Institute of Oncology IRCCS, Milan, Italy.
Mauro D'AmicoMedical Oncology, Ospedali Galliera, Genoa, Italy.
Tania Buttiron-WebberMedical Oncology, Ospedali Galliera, Genoa, Italy.
Irene Maria BriataMedical Oncology, Ospedali Galliera, Genoa, Italy.
Stefano SpinaciBreast Unit, Ospedale Villa Scassi ASL3, Genoa, Italy.
Viviana GalimbertiDivision of Cancer Prevention and Genetics, European Institute of Oncology IRCCS, Milan, Italy.
Lana A VornikDepartment of Clinical Cancer Prevention, University of Texas, MD Anderson Cancer Center, Houston, TX, USA.
Eduardo VilarDepartment of Clinical Cancer Prevention, University of Texas, MD Anderson Cancer Center, Houston, TX, USA.
Powel H BrownDepartment of Clinical Cancer Prevention, University of Texas, MD Anderson Cancer Center, Houston, TX, USA.
Brandy M Heckman-StoddardDivision of Cancer Prevention, NCI, Bethesda, MD, USA.
Eva SzaboDivision of Cancer Prevention, NCI, Bethesda, MD, USA.
Bernardo BonanniDivision of Cancer Prevention and Genetics, European Institute of Oncology IRCCS, Milan, Italy.
Andrea DeCensiMedical Oncology, Ospedali Galliera, Genoa, Italy.

Funding

Italian Ministry of Health 5X1000NCI NIH HHS HHSN261201200034CNCI NIH HHS HHSN261201200034IThe University of Texas MD Anderson Cancer Center Duncan Family Institute for Cancer Prevention and Risk Assessment
6 · The paper itself

Abstract

The drug's activity at the target tissue could help to define the minimal effective dose to promote cancer preventive therapy. Here we present exemestane and sex hormone concentrations within breast tissue from a presurgical study of alternative exemestane schedules. Postmenopausal women candidates for breast surgery for estrogen receptor-positive breast cancer were randomly assigned to exemestane 25 mg once daily (QD), 25 mg 3 times/week (TIW), or 25 mg per week (QW) for 4-6 weeks before surgery. Drug and sex hormones were analyzed from homogenized frozen tissue using a QTRAP 6500+ LC-MS/MS System. Tissue drug concentrations were detectable only in the QD arm with higher concentrations in nonmalignant tissue. Estradiol was nearly suppressed in all groups in the nonmalignant tissue (QD vs TIW P = .364 and QD vs QW P = .693). In contrast, a dose-response trend was observed in cancer tissue. Based on estradiol suppression in nonmalignant tissue, lower exemestane schedules should be explored for breast cancer preventive therapy. Trial Registration: Clinical Trials.gov NCT02598557 and EudraCT 2015-005063-1.

Indexed as

AndrostadienesBreast NeoplasmsEstradiolAgedAromatase InhibitorsBiomarkers, TumorDrug Administration ScheduleFemaleHumansMiddle AgedPostmenopauseReceptors, EstrogenTandem Mass SpectrometryAndrostadienesAromatase InhibitorsBiomarkers, TumorEstradiolexemestaneReceptors, Estrogen

Identifiers

PMID39110531
PMCPMC11630545

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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 OpenQuestion graph.