Evidence map›Paper›PMID 28183331›Full record

Trial reportBreast cancer research : BCR2017

Phase II, randomized, placebo-controlled study of dovitinib in combination with fulvestrant in postmenopausal patients with HR

Antonino Musolino, Mario Campone, Patrick Neven, Neelima Denduluri, Carlos H Barrios, Javier Cortes, Kimberly Blackwell, Hatem Soliman, Zsuzsanna Kahan, Hervé Bonnefoi and 5 more

Registry-linked trialOpen access · goldAbstract readClinical Trial, Phase IIRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Breast cancer research : BCR, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01528345 (A Multicenter, Randomized, Double Blind, Placebo Controlled, Phase II Trial Evaluating the Safety and Efficacy of Dovitinib Combined With Fulvestrant, in Postmenopausal Patients With HER2- and HR+ Breast Cancer That Have Evidence of Disease Progression on or After Prior Endocrine Therapy), which is not on this map. Cited by 56 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
56citing papers in PubMed, 3 pooled it
6.0field-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.

NCT01528345 phase2terminatednot on this map

A Multicenter, Randomized, Double Blind, Placebo Controlled, Phase II Trial Evaluating the Safety and Efficacy of Dovitinib Combined With Fulvestrant, in Postmenopausal Patients With HER2- and HR+ Breast Cancer That Have Evidence of Disease Progression on or After Prior Endocrine Therapy

TypeinterventionalSponsorNovartis PharmaceuticalsRan2012 to 2015Enrolled97ConditionsMetastatic Breast CancerArmsDovitinib, Fulvestrant, Dovitinib Placebo
3 · Its place in the literature

Who cites it

56 citing papers in PubMed, 3 syntheses or guidelines pooled it, 115 citations in OpenAlex.

  1. Pooled it
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  9. Phase Ib Trial of Fulvestrant, Palbociclib, and Erdafitinib, a pan-FGFR Tyrosine Kinase Inhibitor, in HR+/HER2- Metastatic Breast Cancer.Clinical cancer research : an official journal of the American Association for Cancer Research · 2025
    Article
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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

15 authors at 13 institutions in 8 countries.

Antonino MusolinoMedical Oncology Unit, Azienda Ospedaliero-Universitaria di Parma, Via Gramsci 14, 43126, Parma, Italy. amusolino@ao.pr.it.
Mario CamponeInstitut de Cancerologie de l'Ouest, René Gauducheau, Saint-Herblain, France.
Patrick NevenHospital Gasthuisberg, Leuven, Belgium.
Neelima DenduluriVirginia Cancer Specialists, US Oncology Research, Arlington, VA, USA.
Carlos H BarriosPontificia Universidade Católica do Rio Grande do Sul School of Medicine, Porto Alegre, Brazil.
Javier CortesVall d'Hebron Institute of Oncology, Barcelona, Spain.
Kimberly BlackwellDuke University Medical Center, Durham, NC, USA.
Hatem SolimanMoffitt Cancer Center, Tampa, FL, USA.
Zsuzsanna KahanUniversity of Szeged, Szeged, Hungary.
Hervé BonnefoiInstitut Bergonié Comprehensive Cancer Centre, Université de Bordeaux, Bordeaux, France.
Matthew SquiresNovartis Pharma AG, Basel, Switzerland.
Yong ZhangNovartis Pharmaceuticals Corporation, East Hanover, NJ, USA.
Stephanie DeudonNovartis Pharma AG, Basel, Switzerland.
Michael M ShiNovartis Pharmaceuticals Corporation, East Hanover, NJ, USA.
Fabrice AndréInstitut Gustave Roussy, Villejuif, France.
Novartis (Switzerland) · CHNovartis (United States) · USDuke Medical Center · USInstitut Bergonié · FRInstitut de Cancérologie de l'Ouest · FRInstitut Gustave Roussy · FRInstituto Cajal · ESMoffitt Cancer Center · USOspedale di Parma · ITPontifícia Universidade Católica do Rio Grande do Sul · BRUniversitair Ziekenhuis Leuven · BEUniversity of Szeged · HUVirginia Cancer Specialists · US

Funding

Statistical Methods for Cancer Clinical TrialsP01CA142538 · NCI · UNIV OF NORTH CAROLINA CHAPEL HILL · PI KOSOROK, MICHAEL R · 2010 to 2019
$21.3M
NCI NIH HHS P01 CA142538
6 · The paper itself

Abstract

backgroundOverexpression of fibroblast growth factor receptor 1 (FGFR1), found in ≤8% of hormone receptor-positive (HR

methodsIn this randomized, placebo-controlled phase II trial, we evaluated whether the addition of dovitinib to fulvestrant would improve outcomes in postmenopausal patients with HR

resultsFrom 15 May 2012 to 26 November 2014, 97 patients from 36 centers were enrolled. The frequency of FGF pathway amplification was lower than anticipated, and the study was terminated early owing to slow accrual of patients with FGF pathway amplification. The median PFS (95% CI) was 5.5 (3.8-14.0) months vs 5.5 (3.5-10.7) months in the dovitinib vs placebo arms, respectively (HR, 0.68; did not meet predefined efficacy criteria). For the FGF pathway-amplified subgroup (n = 31), the median PFS (95% CI) was 10.9 (3.5-16.5) months vs 5.5 (3.5-16.4) months in the dovitinib vs placebo arms, respectively (HR, 0.64; met the predefined superiority criteria). Frequently reported adverse events in the dovitinib (diarrhea, nausea, vomiting, asthenia, and headache) and placebo (diarrhea, fatigue, nausea, and asthenia) arms were mostly low grade.

conclusionsThe safety profile of dovitinib plus fulvestrant was consistent with the known safety profile of single-agent dovitinib. Dovitinib in combination with fulvestrant showed promising clinical activity in the FGF pathway-amplified subgroup. However, the data reported herein should be interpreted with caution, given that fewer PFS events occurred in the FGF pathway-amplified patients than was expected and that an effect of dovitinib regardless of FGR pathway amplification status cannot be excluded, because the population was smaller than expected.

trial registrationClinicalTrials.gov identifier: NCT01528345 . Registered 31 January 2012.

Indexed as

AdultAgedAged, 80 and overAntineoplastic Combined Chemotherapy ProtocolsBenzimidazolesBreast NeoplasmsDisease ProgressionErb-b2 Receptor Tyrosine KinasesEstradiolFemaleFulvestrantHumansMiddle AgedNeoplasm MetastasisNeoplasm StagingPostmenopause4-amino-5-fluoro-3-(5-(4-methylpiperazin-1-yl)-1H-benzimidazol-2-yl)quinolin-2(1H)-oneBenzimidazolesErb-b2 Receptor Tyrosine KinasesEstradiolFulvestrantQuinolonesReceptors, EstrogenReceptors, ProgesteroneBreast cancerDovitinibEndocrine resistanceFGFFGFRFulvestrantTKI285

Identifiers

PMID28183331
PMCPMC5301372
OpenAlexW2587095588

What OpenQuestion holds

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LicenceCC BY
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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.