Evidence map›Paper›PMID 25001612›Full record

Trial reportBreast cancer research and treatment2014

TBCRC 018: phase II study of iniparib in combination with irinotecan to treat progressive triple negative breast cancer brain metastases.

Carey Anders, Allison M Deal, Vandana Abramson, Minetta C Liu, Anna M Storniolo, John T Carpenter, Shannon Puhalla, Rita Nanda, Amal Melhem-Bertrandt, Nancy U Lin and 14 more

Open access · hybridAbstract readClinical Trial, Phase II
In one paragraph

Trial report in Breast cancer research and treatment, 2014. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 42 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
42citing papers in PubMed, 1 pooled it
4.3field-weighted citation impact, top 6% 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

42 citing papers in PubMed, 1 synthesis or guideline pooled it, 67 citations in OpenAlex.

  1. Pooled it
  2. Trial
  3. Trial
  4. Trial
  5. Trial
  6. Trial
  7. Trial
  8. Review
  9. Chinese Society of Clinical Oncology breast cancer expert consensus on the diagnosis and treatment of breast cancer brain metastasis (2025).Translational breast cancer research : a journal focusing on translational research in breast cancer · 2026
    Review
  10. Review
  11. Article
  12. Review
  13. Review
  14. Update on the Management of Brain Metastasis.Neurotherapeutics : the journal of the American Society for Experimental NeuroTherapeutics · 2022
    Review
  15. Review
  16. Review
  17. Review
  18. Review
  19. Review
  20. 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

24 authors at 16 institutions in 2 countries.

Carey AndersLineberger Comprehensive Cancer Center, University of North Carolina, 450 West Drive, Campus Box 7295, Chapel Hill, NC, 27599, USA, carey_anders@med.unc.edu.
Allison M Deal
Vandana Abramson
Minetta C Liu
Anna M Storniolo
John T Carpenter
Shannon Puhalla
Rita Nanda
Amal Melhem-Bertrandt
Nancy U Lin
P Kelly Marcom
Catherine Van Poznak
Vered Stearns
Michelle Melisko
J Keith Smith
Olga Karginova
Joel Parker
Jonathan Berg
Eric P Winer
Amy Peterman
Aleix Prat
Charles M Perou
Antonio C Wolff
Lisa A Carey
UNC Lineberger Comprehensive Cancer CenterUniversity of North Carolina at Chapel Hill · USDana-Farber Cancer Institute · USSidney Kimmel Comprehensive Cancer Center · USDuke University · USGeorgetown University Medical Center · USIndiana University – Purdue University Indianapolis · USThe University of Texas MD Anderson Cancer Center · USUniversity of Alabama at Birmingham · USUniversity of California, San Francisco · USUniversity of Chicago · USUniversity of Michigan–Ann Arbor · USUniversity of North Carolina at Charlotte · USUPMC Hillman Cancer Center · USVall d'Hebron Institut de Recerca · ESVanderbilt-Ingram Cancer Center

Funding

Virology Research Program (Program 4)P30CA016086 · NCI · UNIV OF NORTH CAROLINA CHAPEL HILL · PI Deborah F. Tate · 1985 to 2026
$201.5M
Women's Cancer Research ProgramP30CA014236 · NCI · DUKE UNIVERSITY · PI DONNA NIEDZWIECKI · 1985 to 2026
$174.8M
Tissue Procurement & PathologyP50CA058223 · NCI · UNIV OF NORTH CAROLINA CHAPEL HILL · PI KATHERINE A. HOADLEY · 1992 to 2026
$59.3M
PARP Inhibition to Treat Triple-Negative Breast Cancer Brain MetastasesK23CA157728 · NCI · UNIV OF NORTH CAROLINA CHAPEL HILL · PI ANDERS, CAREY KERNODLE · 2011 to 2015
$867k
NCI NIH HHS K23 CA157728NCI NIH HHS K23CA157728NCI NIH HHS P30 CA014236NCI NIH HHS P30 CA016086NCI NIH HHS P50 CA058223PHS HHS NIH K23157728
6 · The paper itself

Abstract

Nearly half of patients with advanced triple negative breast cancer (TNBC) develop brain metastases (BM) and most will also have uncontrolled extracranial disease. This study evaluated the safety and efficacy of iniparib, a small molecule anti-cancer agent that alters reactive oxygen species tumor metabolism and penetrates the blood brain barrier, with the topoisomerase I inhibitor irinotecan in patients with TNBC-BM. Eligible patients had TNBC with new or progressive BM and received irinotecan and iniparib every 3 weeks. Time to progression (TTP) was the primary end point; secondary endpoints were response rate (RR), clinical benefit rate (CBR), overall survival (OS), toxicity, and health-related quality of life. Correlative endpoints included molecular subtyping and gene expression studies on pre-treatment archival tissues, and determination of germline BRCA1/2 status. Thirty-seven patients began treatment; 34 were evaluable for efficacy. Five of 24 patients were known to carry a BRCA germline mutation (4 BRCA1, 1 BRCA2). Median TTP was 2.14 months and median OS was 7.8 months. Intracranial RR was 12 %, while intracranial CBR was 27 %. Treatment was well-tolerated; the most common grade 3/4 adverse events were neutropenia and fatigue. Grade 3/4 diarrhea was rare (3 %). Intrinsic subtyping revealed 19 of 21 tumors (79 %) were basal-like, and intracranial response was associated with high expression of proliferation-related genes. This study suggests a modest benefit of irinotecan plus iniparib in progressive TNBC-BM. More importantly, this trial design is feasible and lays the foundation for additional studies for this treatment-refractory disease.

Indexed as

AdultAgedAntineoplastic Combined Chemotherapy ProtocolsBenzamidesBrain NeoplasmsCamptothecinDrug-Related Side Effects and Adverse ReactionsErb-b2 Receptor Tyrosine KinasesFemaleHumansIrinotecanMiddle AgedNeoplasm StagingSurvival AnalysisTriple Negative Breast NeoplasmsVascular Endothelial Growth Factor ABenzamidesCamptothecinERBB2 protein, humanErb-b2 Receptor Tyrosine KinasesiniparibIrinotecanVascular Endothelial Growth Factor AVEGFA protein, human

Identifiers

PMID25001612
PMCPMC4112043
OpenAlexW2043071080

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
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.