Evidence map›Paper›PMID 40569606›Full record

Trial reportClinical cancer research : an official journal of the American Association for Cancer Research2025

FOXC1 Expression Predicts Capecitabine Efficacy in Patients with Triple-Negative Breast Cancer from the GEICAM_CIBOMA Trial.

Federico Rojo, Clive R Taylor, Carlos Barrios, Laura Torrecillas, Manuel Ruiz-Borrego, Sandra Perez-Buira, Jose Bines, Angel Guerrero-Zotano, Jose A Garcia-Saenz, Roberto Torres and 15 more

Registry-linked trialAbstract readRandomized Controlled TrialClinical Trial, Phase III
In one paragraph

Trial report in Clinical cancer research : an official journal of the American Association for Cancer Research, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00130533 (Multicenter, Open-label, Randomized Phase III to Evaluate Efficacy of Maintenance Treatment With Capecitabine Following Standard Adjuvant Chemotherapy in Operable Triple Negative Breast Cancer Patients), 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.

NCT00130533 phase3completednot on this map

Multicenter, Open-label, Randomized Phase III to Evaluate Efficacy of Maintenance Treatment With Capecitabine Following Standard Adjuvant Chemotherapy in Operable Triple Negative Breast Cancer Patients

TypeinterventionalSponsorSpanish Breast Cancer Research GroupRan2006 to 2017Enrolled876ConditionsBreast CancerArmsCapecitabine
3 · Its place in the literature

Who cites it

1 citing paper in PubMed.

  1. Review
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

25 authors.

Federico RojoGEICAM, Spanish Breast Cancer Group, Madrid, Spain.ORCID 0000-0001-9989-0290
Clive R TaylorOnconostic Technologies, Inc. (OT), Evanston, Illinois.ORCID 0000-0002-0832-5366
Carlos BarriosLACOG, Latin American Cooperative Oncology Group, Porto Alegre, Brazil.ORCID 0000-0001-6021-667X
Laura TorrecillasLACOG, Latin American Cooperative Oncology Group, Porto Alegre, Brazil.ORCID 0000-0003-1302-4389
Manuel Ruiz-BorregoGEICAM, Spanish Breast Cancer Group, Madrid, Spain.ORCID 0000-0002-1181-5622
Sandra Perez-BuiraDepartment of Pathology, Fundacion Jimenez Diaz University Hospital Health Research Institute (IIS-FJD, UAM)-CIBERONC, Madrid, Spain.ORCID 0000-0002-2048-4503
Jose BinesLACOG, Latin American Cooperative Oncology Group, Porto Alegre, Brazil.ORCID 0000-0003-2465-8854
Angel Guerrero-ZotanoGEICAM, Spanish Breast Cancer Group, Madrid, Spain.ORCID 0000-0003-0318-9120
Jose A Garcia-SaenzGEICAM, Spanish Breast Cancer Group, Madrid, Spain.ORCID 0000-0001-6880-0301
Roberto TorresLACOG, Latin American Cooperative Oncology Group, Porto Alegre, Brazil.ORCID 0000-0002-1397-4993
Juan de la Haba-RodriguezGEICAM, Spanish Breast Cancer Group, Madrid, Spain.ORCID 0000-0001-5111-1702
Francisco AyalaGEICAM, Spanish Breast Cancer Group, Madrid, Spain.ORCID 0000-0001-6311-920X
Henry GomezLACOG, Latin American Cooperative Oncology Group, Porto Alegre, Brazil.ORCID 0000-0003-2660-1843
Antonio LlombartGEICAM, Spanish Breast Cancer Group, Madrid, Spain.ORCID 0000-0003-4515-8293
Maria Rodriguez de la BorbollaGEICAM, Spanish Breast Cancer Group, Madrid, Spain.ORCID 0009-0001-8586-8444
Jose Manuel Baena-CañadaGEICAM, Spanish Breast Cancer Group, Madrid, Spain.ORCID 0000-0002-8403-9804
Agusti BarnadasGEICAM, Spanish Breast Cancer Group, Madrid, Spain.ORCID 0000-0002-0429-1349
Lourdes CalvoGEICAM, Spanish Breast Cancer Group, Madrid, Spain.ORCID 0000-0001-8314-0241
Jesus HerranzGEICAM, Spanish Breast Cancer Group, Madrid, Spain.ORCID 0000-0002-7385-1311
Raul RinconGEICAM, Spanish Breast Cancer Group, Madrid, Spain.ORCID 0000-0003-0576-0618
Rosalia CaballeroGEICAM, Spanish Breast Cancer Group, Madrid, Spain.ORCID 0000-0002-6027-1748
Begoña BermejoGEICAM, Spanish Breast Cancer Group, Madrid, Spain.ORCID 0000-0001-7773-5994
Partha S RayOnconostic Technologies, Inc. (OT), Evanston, Illinois.ORCID 0000-0002-1594-1386
Miguel MartinGEICAM, Spanish Breast Cancer Group, Madrid, Spain.ORCID 0000-0001-9237-3231
GEICAM_CIBOMA Clinical Trial Group

Funding

AMACMA D8 (patient's association) NAFederación Española de Cáncer de Mama (FECMA) NAFundación Accenture NAInstituto de Salud Carlos III (ISCIII) Biobank platform PT23/00114Instituto de Salud Carlos III (ISCIII) FEDER Fund PI24/00160Pikolinos NA
6 · The paper itself

Abstract

purposeIn a prespecified GEICAM_CIBOMA trial (NCT00130533) correlative analysis, PAM50 non-basal-like breast cancer (non-BLBC) status distinguished patients with triple-negative breast cancer (TNBC) who are most likely to benefit from adjuvant capecitabine. The standardized forkhead box C1 (FOXC1) IHC test has demonstrated strong reliability in classifying the BLBC subtype throughout TNBC cohorts. This translational analysis aimed to evaluate the prognostic/predictive significance of BLBC classification by FOXC1 IHC in the phase III GEICAM_CIBOMA clinical trial. EXPERIMENTAL

designTumor tissues from patients with TNBC randomized to standard (neo)adjuvant chemotherapy followed by capecitabine versus observation were analyzed using the standardized FOXC1 IHC test to assess its BLBC/non-BLBC TNBC subtyping capacity as a distant relapse-free survival clinical outcome predictor of capecitabine benefit (exploratory endpoints: disease-free survival, overall survival, and recurrence-free survival).

resultsA total of 705 (80.5%) patients from the GEICAM_CIBOMA trial were evaluable for FOXC1 expression analysis, with balanced distribution between the trial's treatments. FOXC1 proportion/intensity (VFOXC1) score-based subtyping demonstrated a strong association [AUC = 0.87; 95% confidence interval (CI), 0.84-0.91] and agreement (κ index = 0.43; P < 0.0001) with PAM50 molecular subtyping. VFOXC1 non-BLBC TNBC subtype was a significant independent predictor of clinical benefit with capecitabine for distant relapse-free survival (HR, 0.44; 95% CI, 0.25-0.76; P = 0.003). This predictive effect of VFOXC1 non-BLBC on capecitabine efficacy was further confirmed at disease-free survival (HR, 0.47; 95% CI, 0.28-0.78; P = 0.003), overall survival (HR, 0.48; 95% CI, 0.24-0.96; P = 0.038), and recurrence-free survival (HR, 0.39; 95% CI, 0.22-0.72; P = 0.002).

conclusionsThis ambispective GEICAM_CIBOMA translational analysis validated FOXC1-based basal-like/non-basal-like subtyping as a pragmatic alternative to PAM50 subtyping and independently predicted the benefit of adding capecitabine to standard (neo)adjuvant chemotherapy in TNBC.

Indexed as

Biomarkers, TumorCapecitabineForkhead Transcription FactorsTriple Negative Breast NeoplasmsAdultAgedChemotherapy, AdjuvantDisease-Free SurvivalFemaleGene Expression Regulation, NeoplasticHumansMiddle AgedPrognosisTreatment OutcomeBiomarkers, TumorCapecitabineForkhead Transcription FactorsFOXC1 protein, human

Identifiers

PMID40569606
PMCPMC12402780

What Socratic holds

Textmetadata
LicenceCC BY-NC-ND
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.