Evidence map›Paper›PMID 29948356›Full record

ArticleInvestigational new drugs2019

A phase Ib study of sonidegib (LDE225), an oral small molecule inhibitor of smoothened or Hedgehog pathway, in combination with docetaxel in triple negative advanced breast cancer patients: GEICAM/2012-12 (EDALINE) study.

Manuel Ruiz-Borrego, Begoña Jimenez, Silvia Antolín, Jose A García-Saenz, Jesús Corral, Yolanda Jerez, José Trigo, Ander Urruticoechea, Helena Colom, Nuria Gonzalo and 7 more

Registry-linked trialAbstract readClinical Trial, Phase IMulticenter Study
PubMed Publisher
In one paragraph

Article in Investigational new drugs, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02027376 (A Phase Ib Dose Escalation, Open Label, Multicenter Study Evaluating LDE225), which is not on this map. Cited by 47 papers.

0numbers the graph read from it
0cells of the map it votes in
47citing papers in PubMed
1.9field-weighted citation impact, top 14% 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.

NCT02027376 phase1completednot on this map

A Phase Ib Dose Escalation, Open Label, Multicenter Study Evaluating LDE225 (Sonidegib) in Combination With Docetaxel in Triple Negative (TN) Advanced Breast Cancer (ABC) Patients "EDALINE"

TypeinterventionalSponsorSpanish Breast Cancer Research GroupRan2014 to 2016Enrolled12ConditionsAdvanced Breast CancerArmsLDE225, Docetaxel
3 · Its place in the literature

Who cites it

47 citing papers in PubMed, 54 citations in OpenAlex.

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  11. Protein Marker-Dependent Drug Discovery Targeting Breast Cancer Stem Cells.International journal of molecular sciences · 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

17 authors at 9 institutions in 1 country.

Manuel Ruiz-BorregoDepartment of Medical Oncology, Hospital Universitario Virgen del Rocío, Sevilla, Spain.
Begoña JimenezDepartment of Medical Oncology, Hospital Clínico Universitario Virgen de la Victoria, IBIMA, Málaga, Spain.
Silvia AntolínDepartment of Medical Oncology, Complejo Hospitalario Universitario A Coruña, A Coruña, Spain.
Jose A García-SaenzDepartment of Medical Oncology, IdISSC, CIBERONC-ISCIII, Hospital Clínico San Carlos, Madrid, Spain.
Jesús CorralDepartment of Medical Oncology, Hospital Universitario Virgen del Rocío, Sevilla, Spain.
Yolanda JerezDepartment of Medical Oncology, Instituto de Investigación Sanitaria Gregorio Marañón, Madrid, Spain.
José TrigoDepartment of Medical Oncology, Hospital Clínico Universitario Virgen de la Victoria, IBIMA, Málaga, Spain.
Ander UrruticoecheaDepartment of Medical Oncology, Fundación Onkologikoa, San Sebastián, Spain.
Helena ColomDepartment of Biopharmaceutics and Pharmacokinetics, School of Pharmacy, University of Barcelona, Barcelona, Spain.
Nuria GonzaloDepartment of Pharmacy, IDIBELL, Catalan Institute of Oncology, Hospital Duran i Reynals, L'Hospitalet de Llobregat, Barcelona, Spain.
Carmen MuñozDepartment of Pharmacy, IDIBELL, Catalan Institute of Oncology, Hospital Duran i Reynals, L'Hospitalet de Llobregat, Barcelona, Spain.
Sara BenitoGEICAM, Spanish Breast Cancer Group, San Sebastián de los Reyes, Madrid, Spain.
Rosalía CaballeroGEICAM, Spanish Breast Cancer Group, San Sebastián de los Reyes, Madrid, Spain.
Susana BezaresGEICAM, Spanish Breast Cancer Group, San Sebastián de los Reyes, Madrid, Spain.
Eva CarrascoGEICAM, Spanish Breast Cancer Group, San Sebastián de los Reyes, Madrid, Spain.
Federico RojoDepartment of Pathology, Instituto de Investigación Sanitaria Fundación Jiménez Díaz, Centro de Investigación Biomédica en Red de Oncología, CIBERONC-ISCIII, Madrid, Spain.
Miguel MartínDepartment of Medical Oncology, Instituto de Investigación Sanitaria Gregorio Marañón, Universidad Complutense, Centro de Investigación Biomédica en Red de Oncología, CIBERONC-ISCIII, C/Dr. Esquerdo 46, 28009, Madrid, Spain. mmartin@geicam.org.ORCID 0000-0001-9237-3231
GEICAM – Spanish Breast Cancer Group · ESInstituto de Salud Carlos III · ESHospital Clínico Universitario Virgen de la Victoria · ESHospital Universitario Virgen del Rocío · ESInstitut d'Investigació Biomédica de Bellvitge · ESComplexo Hospitalario Universitario A Coruña · ESHospital General Universitario Gregorio Marañón · ESOnkologikoa · ESUniversitat de Barcelona · ES

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Up-regulation of the Hedgehog (Hh) pathway is implicated in the genesis of a wide range of tumors including triple negative breast cancer (TNBC). Sonidegib is a potent and selective oral inhibitor of Smo, a key component of the Hh signaling pathway. We designed a phase I clinical study to explore the combination of sonidegib plus docetaxel (fixed dose at 75 mg/m

Indexed as

AdultAgedAntineoplastic Combined Chemotherapy ProtocolsBiphenyl CompoundsCarcinoma, Ductal, BreastDocetaxelFemaleHumansMaximum Tolerated DoseMiddle AgedPrognosisPyridinesSmoothened ReceptorTissue DistributionTriple Negative Breast NeoplasmsBiphenyl CompoundsDocetaxelPyridinesSmoothened ReceptorSMO protein, humansonidegibadvanced breast cancerdocetaxelHedgehoghormone receptor and HER2 negativesonidegibTriple negative

Identifiers

PMID29948356
OpenAlexW2807104695

What OpenQuestion holds

Textmetadata
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 OpenQuestion graph.