Evidence map›Paper›PMID 34417675›Full record

Trial reportBreast cancer research and treatment2021

Phase II trial of veliparib and temozolomide in metastatic breast cancer patients with and without BRCA1/2 mutations.

Jing Xu, Tanya E Keenan, Beth Overmoyer, Nadine M Tung, Rebecca S Gelman, Karleen Habin, Judy E Garber, Leif W Ellisen, Eric P Winer, Paul E Goss and 3 more

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

Trial report in Breast cancer research and treatment, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01009788 (A Phase 2 Study of ABT-888 and Temozolomide for Metastatic Breast Cancer and an Expansion Cohort in BRCA1/2 Mutation Carriers), which is not on this map. Cited by 14 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
14citing papers in PubMed, 1 pooled it
1.7field-weighted citation impact, top 13% 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.

NCT01009788 phase2completednot on this map

A Phase 2 Study of ABT-888 and Temozolomide for Metastatic Breast Cancer and an Expansion Cohort in BRCA1/2 Mutation Carriers

TypeinterventionalSponsorSteven J Isakoff, MD, PhDRan2009 to 2015Enrolled63ConditionsBreast Cancer, Metastatic Breast Cancer, BRCA1 Gene Mutation, brca2 Gene MutationArmsABT-888, temozolomide
3 · Its place in the literature

Who cites it

14 citing papers in PubMed, 1 synthesis or guideline pooled it, 22 citations in OpenAlex.

  1. Pooled it
  2. Review
  3. Genotoxicity of cancer therapies and the risk of secondary malignancies: toward personalized prevention.Clinical & translational oncology : official publication of the Federation of Spanish Oncology Societies and of the National Cancer Institute of Mexico · 2026
    Review
  4. Article
  5. Article
  6. Review
  7. Review
  8. Review
  9. Review
  10. Article
  11. Review
  12. Article
  13. Review
  14. BRCA1 and Breast Cancer: Molecular Mechanisms and Therapeutic Strategies.Frontiers in cell and developmental biology · 2022
    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

13 authors at 3 institutions in 2 countries.

Jing Xu *Massachusetts General Hospital Cancer Center, 55 Fruit Street, Boston, MA, 02141, USA.
Tanya E Keenan *Massachusetts General Hospital Cancer Center, 55 Fruit Street, Boston, MA, 02141, USA.
Beth OvermoyerDana-Farber Cancer Institute, Boston, USA.
Nadine M TungBeth Israel Deaconess Medical Center, Boston, USA.
Rebecca S GelmanDana-Farber Cancer Institute, Boston, USA.
Karleen HabinMassachusetts General Hospital Cancer Center, 55 Fruit Street, Boston, MA, 02141, USA.
Judy E GarberDana-Farber Cancer Institute, Boston, USA.
Leif W EllisenMassachusetts General Hospital Cancer Center, 55 Fruit Street, Boston, MA, 02141, USA.
Eric P WinerDana-Farber Cancer Institute, Boston, USA.
Paul E GossMassachusetts General Hospital Cancer Center, 55 Fruit Street, Boston, MA, 02141, USA.
Beow Y YeapMassachusetts General Hospital Cancer Center, 55 Fruit Street, Boston, MA, 02141, USA.
Bruce A ChabnerMassachusetts General Hospital Cancer Center, 55 Fruit Street, Boston, MA, 02141, USA. BCHABNER@mgh.harvard.edu.ORCID http://orcid.org/0000-0002-6306-2802
Steven J IsakoffMassachusetts General Hospital Cancer Center, 55 Fruit Street, Boston, MA, 02141, USA.
Harvard University · USBeth Israel Deaconess Medical Center · USMassachusetts General Hospital · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

purposeWe evaluated the efficacy and safety of poly-(adenosine diphosphate-ribose) polymerase (PARP) 1 and 2 inhibitor veliparib and temozolomide in metastatic breast cancer patients with and without germline BRCA1/2 mutations.

methodsIn this single-arm phase II trial, patients with metastatic breast cancer received veliparib 30 to 40 mg twice daily on days 1 to 7 with concurrent temozolomide 150 mg/m

resultsIn the primary cohort of 41 unselected patients, which included 9 BRCA mutation carriers, the ORR was 10% and clinical benefit rate at 4 months (CBR) was 27%. In the expansion cohort of 21 BRCA1/2 carriers, the ORR was 14% and CBR was 43%. Among all 30 BRCA1/2 carriers, the ORR was 23% versus 0% among non-carriers. In the subset of BRCA1/2 carriers, the ORR was 32% among platinum-naïve patients versus 9% among platinum-exposed patients. The median PFS was 3.3 months among BRCA1/2 carriers compared to 1.8 months among non-carriers (HR: 0.48, p = 0.006). A longer median PFS of 6.2 months was observed among BRCA1/2 carriers who had no prior platinum therapy. The most common grade 3 and 4 toxicities were thrombocytopenia (32%) and neutropenia (21%) that generally improved with dose modifications.

conclusionVeliparib and temozolomide demonstrated clinical activity in platinum-naïve BRCA-associated metastatic breast cancer with manageable toxicity at doses of veliparib well below the single-agent active dose. Although the study did not meet its primary endpoint in unselected nor BRCA-associated breast cancer, this regimen was further evaluated in the BROCADE 2 study.

trial registrationNCT01009788 (ClinicalTrials.gov), November 9, 2009.

Indexed as

Breast NeoplasmsAntineoplastic Combined Chemotherapy ProtocolsBenzimidazolesBRCA1 ProteinCarboplatinFemaleGerm-Line MutationHumansMutationTemozolomideBenzimidazolesBRCA1 ProteinBRCA1 protein, humanCarboplatinTemozolomideveliparibAlkylating agentBRCA mutationsBreast cancerPARP inhibitorTemozolomideVeliparib

Identifiers

PMID34417675
OpenAlexW3194743843

What OpenQuestion holds

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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.