Evidence map›Paper›PMID 25779953›Full record

Trial reportClinical cancer research : an official journal of the American Association for Cancer Research2015

TBCRC 019: A Phase II Trial of Nanoparticle Albumin-Bound Paclitaxel with or without the Anti-Death Receptor 5 Monoclonal Antibody Tigatuzumab in Patients with Triple-Negative Breast Cancer.

Andres Forero-Torres, Katherine E Varley, Vandana G Abramson, Yufeng Li, Christos Vaklavas, Nancy U Lin, Minetta C Liu, Hope S Rugo, Rita Nanda, Anna M Storniolo and 12 more

Open access · bronzeAbstract readClinical Trial, Phase IIMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in Clinical cancer research : an official journal of the American Association for Cancer Research, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 49 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
49citing papers in PubMed, 3 pooled it
3.7field-weighted citation impact, top 5% 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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

49 citing papers in PubMed, 3 syntheses or guidelines pooled it, 70 citations in OpenAlex.

  1. Pooled it
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  6. Article
  7. Programmed cell death in triple-negative breast cancer.Cellular & molecular biology letters · 2025
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  17. Targeting Apoptosis in Cancer.Current oncology reports · 2022
    Review
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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

22 authors at 3 institutions in 1 country.

Andres Forero-TorresUniversity of Alabama at Birmingham, Birmingham, Alabama. aforero@uab.edu.
Katherine E VarleyHudsonAlpha Institute for Biotechnology, Huntsville, Alabama.
Vandana G AbramsonVanderbilt-Ingram Cancer Center, Nashville, Tennessee.
Yufeng LiUniversity of Alabama at Birmingham, Birmingham, Alabama.
Christos VaklavasUniversity of Alabama at Birmingham, Birmingham, Alabama.
Nancy U LinDana-Farber Cancer Institute, Boston, Massachusetts.
Minetta C LiuGeorgetown University Hospital, Washington, District of Columbia.
Hope S RugoUniversity of California, San Francisco Helen Diller Family Comprehensive Cancer Center, San Francisco, California.
Rita NandaThe University of Chicago, Chicago, Illinois.
Anna M StornioloIndiana University Melvin and Bren Simon Cancer Center, Indianapolis, Indiana.
Tiffany A TrainaMemorial Sloan-Kettering Cancer Center, New York, New York.
Sujata PatilMemorial Sloan-Kettering Cancer Center, New York, New York.
Catherine H Van PoznakUniversity of Michigan, Ann Arbor, Michigan.
Julie R NangiaBaylor College of Medicine, Houston, Texas.
William J IrvinUniversity of North Carolina, Chapel Hill, North Carolina.
Helen KrontirasUniversity of Alabama at Birmingham, Birmingham, Alabama.
Jennifer F De Los SantosUniversity of Alabama at Birmingham, Birmingham, Alabama.
Paul HaluskaMayo Clinic College of Medicine, Rochester, Minnesota.
William GrizzleUniversity of Alabama at Birmingham, Birmingham, Alabama.
Richard M MyersHudsonAlpha Institute for Biotechnology, Huntsville, Alabama.
Antonio C WolffJohns Hopkins Kimmel Comprehensive Cancer Center, Baltimore, Maryland.
Translational Breast Cancer Research Consortium (TBCRC)
University of Alabama at Birmingham · USDana-Farber Cancer Institute · USUniversity of Michigan–Ann Arbor · US

Funding

XRAY CRYSTALLOGRAPHYP30CA013148 · NCI · UNIVERSITY OF ALABAMA AT BIRMINGHAM · PI Robert S Welner · 1985 to 2026
$165.9M
UAB Rexinoids for Breast Cancer PreventionP50CA089019 · NCI · UNIVERSITY OF ALABAMA AT BIRMINGHAM · PI GRIZZLE, WILLIAM E. · 2000 to 2011
$26.0M
NCI NIH HHS P30 CA013148NCI NIH HHS P50 CA089019NCI NIH HHS P50CA089019
6 · The paper itself

Abstract

purposeTigatuzumab (TIG), an agonistic anti-DR5 antibody, triggers apoptosis in DR5(+) human tumor cells without crosslinking. TIG has strong in vitro/in vivo activity against basal-like breast cancer cells enhanced by chemotherapy agents. This study evaluates activity of TIG and chemotherapy in patients with metastatic triple-negative breast cancer (TNBC). EXPERIMENTAL

designRandomized 2:1 phase II trial of albumin-bound paclitaxel (nab-PAC) ± TIG in patients with TNBC stratified by prior chemotherapy. Patients received nab-PAC weekly × 3 ± TIG every other week, every 28 days. Primary objective was within-arm objective response rate (ORR). Secondary objectives were safety, progression-free survival (PFS), clinical benefit, and TIG immunogenicity. Metastatic research biopsies were required.

resultsAmong 64 patients (60 treated; TIG/nab-PAC n = 39 and nab-PAC n = 21), there were 3 complete remissions (CR), 8 partial remissions (PR; 1 almost CR), 11 stable diseases (SD), and 17 progressive diseases (PD) in the TIG/nab-PAC arm (ORR, 28%), and no CRs, 8 PRs, 4 SDs, and 9 PDs in the nab-PAC arm (ORR, 38%). There was a numerical increase in CRs and several patients had prolonged PFS (1,025+, 781, 672, 460, 334) in the TIG/nab-PAC arm. Grade 3 toxicities were 28% and 29%, respectively, with no grade 4-5. Exploratory analysis suggests an association of ROCK1 gene pathway activation with efficacy in the TIG/nab-PAC arm.

conclusionsORR and PFS were similar in both. Preclinical activity of TIG in basal-like breast cancer and prolonged PFS in few patients in the combination arm support further investigation of anti-DR5 agents. ROCK pathway activation merits further evaluation.

Indexed as

AdultAgedAntibodies, Monoclonal, HumanizedAntineoplastic Combined Chemotherapy ProtocolsBiopsyFemaleHumansMiddle AgedNanoparticlesPaclitaxelReceptors, TNF-Related Apoptosis-Inducing LigandRetreatmentTreatment OutcomeTriple Negative Breast NeoplasmsAntibodies, Monoclonal, HumanizedPaclitaxelReceptors, TNF-Related Apoptosis-Inducing Ligandtigatuzumab

Identifiers

PMID25779953
PMCPMC6186432
OpenAlexW1963083447

What OpenQuestion holds

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LicenceTDM
Read underepoch 390

Registered trials

None linked

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.