Evidence map›Paper›PMID 28830796›Full record

Trial reportClinical breast cancer2017

RESILIENCE: Phase III Randomized, Double-Blind Trial Comparing Sorafenib With Capecitabine Versus Placebo With Capecitabine in Locally Advanced or Metastatic HER2-Negative Breast Cancer.

José Baselga, Claudio Zamagni, Patricia Gómez, Begoña Bermejo, Shigenori E Nagai, Bohuslav Melichar, Arlene Chan, Lászlo Mángel, Jonas Bergh, Frederico Costa and 10 more

Registry-linked trialAbstract readClinical Trial, Phase IIIComparative StudyRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Clinical breast cancer, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01234337 (A Phase III Randomized, Double Blind, Placebo-controlled Trial Comparing Capecitabine Plus Sorafenib Versus Capecitabine Plus Placebo in the Treatment of Locally Advanced or Metastatic HER2-Negative Breast Cancer), which is not on this map. Cited by 25 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
25citing papers in PubMed, 2 pooled it
2.0field-weighted citation impact, top 12% 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.

NCT01234337 phase3completednot on this map

A Phase III Randomized, Double Blind, Placebo-controlled Trial Comparing Capecitabine Plus Sorafenib Versus Capecitabine Plus Placebo in the Treatment of Locally Advanced or Metastatic HER2-Negative Breast Cancer

TypeinterventionalSponsorBayerRan2011 to 2017Enrolled537ConditionsBreast CancerArmsSorafenib (Nexavar, BAY43-9006), Placebo, Capecitabine
3 · Its place in the literature

Who cites it

25 citing papers in PubMed, 2 syntheses or guidelines pooled it, 47 citations in OpenAlex.

  1. Pooled it
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  8. Targeting estrogen-regulated system xCell death & disease · 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

20 authors at 16 institutions in 12 countries.

José BaselgaMemorial Sloan Kettering Cancer Center, New York, NY. Electronic address: baselgaj@mskcc.org.
Claudio ZamagniS. Orsola Malpighi Hospital, Bologna, Italy.
Patricia GómezVall d'Hebron University Hospital, Vall d'Hebron Institute of Oncology, Barcelona, Spain.
Begoña BermejoHospital Clínico Universitario de Valencia, Valencia, Spain.
Shigenori E NagaiSaitama Cancer Center, Saitama, Japan.
Bohuslav MelicharPalacky University Medical School and Teaching Hospital, Olomouc, Czech Republic.
Arlene ChanCurtin Health Innovation Research Institute, Curtin University, Perth, Australia.
Lászlo MángelUniversity of Pécs, Pécs, Hungary.
Jonas BerghKarolinska Institutet and University Hospital, Stockholm, Sweden.
Frederico CostaHospital Sírio Libanês, São Paulo, Brazil.
Henry L GómezInstituto Nacional de Enfermedades Neoplásicas, Lima, Peru.
William J GradisharNorthwestern University Feinberg School of Medicine, Chicago, IL.
Clifford A HudisMemorial Sloan Kettering Cancer Center, New York, NY.
Bernardo L RapoportThe Medical Oncology Center of Rosebank and Linksfield Park Hospital, Johannesburg, South Africa.
Henri RochéInstitut Claudius Régaud, Toulouse, France.
Patricia MaedaBayer HealthCare Pharmaceuticals, Whippany, NJ.
Liping HuangBayer HealthCare Pharmaceuticals, Whippany, NJ.
Gerold MeinhardtBayer HealthCare Pharmaceuticals, Whippany, NJ.
Joshua ZhangBayer HealthCare Pharmaceuticals, Whippany, NJ.
Lee S SchwartzbergThe West Clinic, Memphis, TN.
Bayer (United States) · USMemorial Sloan Kettering Cancer Center · USCampbell Clinic · USCurtin University · AUHospital Clínico Universitario de Valencia · ESHospital Sírio-Libanês · BRInstitut Claudius Regaud · FRInstituto Nacional de Enfermedades Neoplásicas · PEIRCCS Azienda Ospedliero-Universitaria di Bologna Policlinico di Sant'Orsola · ITKarolinska University Hospital · SENorthwestern University · USPalacký University Olomouc · CZSaitama Cancer Center · JPThe Medical Oncology Centre of Rosebank · ZAUniversity of Pecs · HUVall d'Hebron Hospital Universitari · ES

Funding

X-RAY CRYSTALLOGRAPHYP30CA008748 · NCI · SLOAN-KETTERING INSTITUTE FOR CANCER RES · PI SELWYN M VICKERS · 1985 to 2026
$347.4M
NCI NIH HHS P30 CA008748
6 · The paper itself

Abstract

introductionSorafenib is a multikinase inhibitor with antiangiogenic/antiproliferative activity. In this randomized, double-blind, placebo-controlled phase III trial, we assessed first- or second-line capecitabine with sorafenib or placebo in patients with locally advanced/metastatic HER2-negative breast cancer resistant to a taxane and anthracycline and with known estrogen/progesterone receptor status. PATIENTS AND

methodsA total of 537 patients were randomized to capecitabine 1000 mg/m

resultsTreatment with sorafenib with capecitabine, compared with capecitabine with placebo, did not prolong median PFS (5.5 vs. 5.4 months; hazard ratio [HR], 0.973; 95% confidence interval [CI], 0.779-1.217; P = .811) or overall survival (OS; 18.9 vs. 20.3 months; HR, 1.195; 95% CI, 0.943-1.513; P = .140); or enhance overall response rate (ORR; 13.5% vs. 15.5%; P = .515). Any grade toxicities (sorafenib vs. placebo) included palmar-plantar erythrodysesthesia syndrome (PPES; 79.2% vs. 59.6%), diarrhea (47.3% vs. 37.8%), mucosal inflammation (15.4% vs. 6.7%), and hypertension (26.2% vs. 5.6%). Grade 3/4 toxicities included PPES (15.4% vs. 7.1%), diarrhea (4.2% vs. 6.4%), and vomiting (3.5% vs. 0.7%).

conclusionThe combination of sorafenib with capecitabine did not improve PFS, OS, or ORR in patients with HER2-negative advanced breast cancer. Rates of Grade 3 toxicities were higher in the sorafenib arm.

Indexed as

Administration, OralAgedAnthracyclinesAntineoplastic Combined Chemotherapy ProtocolsBreast NeoplasmsBridged-Ring CompoundsCapecitabineDiarrheaDisease-Free SurvivalDouble-Blind MethodDrug Administration ScheduleDrug Resistance, NeoplasmErb-b2 Receptor Tyrosine KinasesFemaleHand-Foot SyndromeHumansAnthracyclinesBridged-Ring CompoundsCapecitabineERBB2 protein, humanErb-b2 Receptor Tyrosine KinasesNiacinamidePhenylurea CompoundsPlacebosSorafenibtaxaneTaxoidsHormone-receptor statusMultikinase inhibitorOverall survivalProgression-free survivalRaf kinases

Identifiers

PMID28830796
PMCPMC5699974
OpenAlexW2620080766

What OpenQuestion holds

Textmetadata
LicenceTDM
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.