Evidence map›Paper›PMID 27739325›Full record

Trial reportFuture oncology (London, England)2017

A randomized Phase II study of veliparib with temozolomide or carboplatin/paclitaxel versus placebo with carboplatin/paclitaxel in BRCA1/2 metastatic breast cancer: design and rationale.

Steven J Isakoff, Shannon Puhalla, Susan M Domchek, Michael Friedlander, Bella Kaufman, Mark Robson, Melinda L Telli, Véronique Diéras, Hyo Sook Han, Judy E Garber and 5 more

Registry-linked trialOpen access · hybridAbstract readClinical Trial, Phase IIRandomized Controlled Trial
In one paragraph

Trial report in Future oncology (London, England), 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01506609 (A Randomized, Phase 2 Study of the Efficacy and Tolerability of Veliparib in Combination With Temozolomide or Veliparib in Combination With Carboplatin and Paclitaxel Versus Placebo Plus Carboplatin and Paclitaxel in Subjects With BRCA1 or BRCA2 Mutation and Metastatic 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
3.0field-weighted citation impact, top 7% 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.

NCT01506609 phase2completednot on this map

A Randomized, Phase 2 Study of the Efficacy and Tolerability of Veliparib in Combination With Temozolomide or Veliparib in Combination With Carboplatin and Paclitaxel Versus Placebo Plus Carboplatin and Paclitaxel in Subjects With BRCA1 or BRCA2 Mutation and Metastatic Breast Cancer

TypeinterventionalSponsorAbbVieRan2012 to 2020Enrolled294ConditionsMetastatic Breast CancerArmsPlacebo, Veliparib, Carboplatin, Temozolomide, Paclitaxel
3 · Its place in the literature

Who cites it

25 citing papers in PubMed, 2 syntheses or guidelines pooled it, 45 citations in OpenAlex.

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  15. Prospective Evaluation of UniversalJNCI cancer spectrum · 2020
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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 11 institutions in 4 countries.

Steven J IsakoffDepartment of Medicine, Massachusetts General Hospital, Boston, MA 02114, USA.
Shannon PuhallaDepartment of Medicine, University of Pittsburgh Cancer Institute, Pittsburgh, PA 15232, USA.
Susan M DomchekBasser Center for BRCA, University of Pennsylvania, Philadelphia, PA 19104, USA.
Michael FriedlanderGynaecological Cancer Centre, Royal Hospital for Women, Sydney, NSW 2031, Australia.
Bella KaufmanDepartment of General Oncology, Chaim Sheba Medical Center, Ramat Gan 52 621, Israel.
Mark RobsonDepartment of Medicine, Memorial Sloan Kettering Cancer Center, New York, NY 10022, USA.
Melinda L TelliDepartment of Medical Oncology, Stanford University School of Medicine, Stanford, CA 94305, USA.
Véronique DiérasDepartment of Medical Oncology, Institut Curie, Paris 75248, France.
Hyo Sook HanThe Center for Women's Oncology, Moffitt Cancer Center, Tampa, FL 33612, USA.
Judy E GarberDepartment of Medical Oncology, Dana-Farber Cancer Institute, Boston, MA 02215, USA.
Eric F JohnsonAbbVie Inc., Chicago, IL 60064, USA.
David MaagAbbVie Inc., Chicago, IL 60064, USA.
Qin QinAbbVie Inc., Chicago, IL 60064, USA.
Vincent L GirandaAbbVie Inc., Chicago, IL 60064, USA.
Stacie P ShepherdAbbVie Inc., Chicago, IL 60064, USA.
AbbVie (United States) · USDana-Farber Cancer Institute · USInstitut Curie · FRMassachusetts General Hospital · USMemorial Sloan Kettering Cancer Center · USMoffitt Cancer Center · USRoyal Hospital for Women · AUSheba Medical Center · ILStanford University · USUniversity City Science Center · USUPMC Hillman Cancer Center · US

Funding

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

Abstract

Veliparib is an orally administered poly(ADP-ribose) polymerase inhibitor that is being studied in Phase I-III clinical trials, including Phase III studies in non-small-cell lung cancer, ovarian cancer and breast cancer. Tumor cells with deleterious BRCA1 or BRCA2 mutations are deficient in homologous recombination DNA repair and are intrinsically sensitive to platinum therapy and poly(ADP-ribose) polymerase inhibitors. We describe herein the design and rationale of a Phase II trial investigating whether the addition of veliparib to temozolomide or carboplatin/paclitaxel provides clinical benefit over carboplatin/paclitaxel with placebo in patients with locally recurrent or metastatic breast cancer harboring a deleterious BRCA1 or BRCA2 germline mutation (Trial registration: EudraCT 2011-002913-12, NCT01506609).

Indexed as

Clinical ProtocolsAntineoplastic Combined Chemotherapy ProtocolsBenzimidazolesBRCA1 ProteinBRCA2 ProteinBreast NeoplasmsCarboplatinDacarbazineDrug MonitoringFemaleHumansModels, StatisticalPaclitaxelResearch DesignSample SizeTemozolomideBenzimidazolesBRCA1 ProteinBRCA2 ProteinCarboplatinDacarbazinePaclitaxelTemozolomideveliparibBRCA1BRCA2breast cancerDNA damagePARPPARP inhibitorPARP trappingsynthetic lethalityveliparib

Identifiers

PMID27739325
PMCPMC5618936
OpenAlexW2531029084

What OpenQuestion holds

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LicenceCC BY-NC-ND
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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.