Evidence map›Paper›PMID 21147690›Full record

Trial reportClinical breast cancer2010

Phase II study of bortezomib and pegylated liposomal doxorubicin in the treatment of metastatic breast cancer.

William J Irvin, Robert Z Orlowski, Wing-Keung Chiu, Lisa A Carey, Frances A Collichio, Philip S Bernard, Inge J Stijleman, Charles Perou, Anastasia Ivanova, E Claire Dees

Registry-linked trialOpen access · greenAbstract readClinical Trial, Phase II
In one paragraph

Trial report in Clinical breast cancer, 2010. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT06900647 (Phase I Study to Evaluate the Safety and Preliminary Efficacy of Bortezomib Combined With Cisplatin in Patients With Recurrent or Metastatic Breast Cancer), which is not on this map. Cited by 16 papers.

0numbers the graph read from it
0cells of the map it votes in
16citing papers in PubMed
1.1field-weighted citation impact, top 23% 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.

NCT06900647 phase1recruitingnot on this mapstarted 2025, after this paper: background citation

Phase I Study to Evaluate the Safety and Preliminary Efficacy of Bortezomib Combined With Cisplatin in Patients With Recurrent or Metastatic Breast Cancer

TypeinterventionalSponsorSun Yat-sen UniversityRan2025 to 2028Enrolled20ConditionsMetastatic Breast Cancer, Recurrent Breast CancerArmsBortezomib (B), Cisplatin (CDDP)
3 · Its place in the literature

Who cites it

16 citing papers in PubMed, 29 citations in OpenAlex.

  1. Article
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  3. Review
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  7. Article
  8. Clinical management of breast cancer heterogeneity.Nature reviews. Clinical oncology · 2015
    Review
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  10. Review
  11. Article
  12. Review
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  15. Article
  16. 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

10 authors at 5 institutions in 1 country.

William J IrvinThe Lineberger Comprehensive Cancer Center, and Division of Hematology/Oncology, School of Medicine, University of North Carolina at Chapel Hill, 170 Manning Drive, Chapel Hill, NC 27599, USA.
Robert Z Orlowski
Wing-Keung Chiu
Lisa A Carey
Frances A Collichio
Philip S Bernard
Inge J Stijleman
Charles Perou
Anastasia Ivanova
E Claire Dees
UNC Lineberger Comprehensive Cancer CenterUniversity of North Carolina at Chapel Hill · USHuntsman Cancer Institute · USThe University of Texas MD Anderson Cancer Center · USUniversity of Utah · US

Funding

Tissue Procurement & PathologyP50CA058223 · NCI · UNIV OF NORTH CAROLINA CHAPEL HILL · PI KATHERINE A. HOADLEY · 1992 to 2026
$59.3M
Zonisamide in Patients with Neuropathic Pain Associated with Diabetic NeuropathyM01RR000046 · NCRR · UNIV OF NORTH CAROLINA CHAPEL HILL · PI JOY, MELANIE S · 1985 to 2008
$38.5M
UNC Oncology K12K12CA120780 · NCI · UNIV OF NORTH CAROLINA CHAPEL HILL · PI WILLIAM Y. KIM · 2007 to 2026
$9.6M
NCI NIH HHS 5-P50-CA58223NCI NIH HHS K12 CA120780NCI NIH HHS P50 CA058223NCRR NIH HHS M01 RR000046NCRR NIH HHS RR00046
6 · The paper itself

Abstract

backgroundBased on preclinical studies and a phase I trial of the combination of bortezomib and pegylated liposomal doxorubicin (PLD), which both showed activity in breast cancer, we conducted a phase II study of this regimen in patients with metastatic breast cancer. PATIENTS AND

methodsPatients received bortezomib 1.3 mg/m2 on days 1, 4, 8, and 11 of an every-21-day cycle, along with PLD 30 mg/m2 on day 4. The primary objective was to evaluate the response rate of this combination, while secondary objectives were to obtain further safety data about this combination, to evaluate the time to disease progression (TTP), and to evaluate response by the breast cancer subtype.

resultsOne of 12 evaluable patients had a partial response (8%), while 3 (25%) had stable disease. At 26 months follow-up, the median overall survival was 4.3 months (95% CI, 1.2-26.2) and the median TTP was 1.3 months (95% CI, 0.8-14.0 months). The combination was well tolerated, with the most common events including low-grade nausea and vomiting, neutropenia, and neuropathy, and no cardiac toxicity was seen. Of the 7 tumors subtyped, no association was seen between intrinsic subtype or receptor status and response.

conclusionThe combination of PLD and bortezomib was well tolerated but has minimal activity in heavily pretreated unselected metastatic breast cancer.

Indexed as

AdultAgedAntineoplastic Combined Chemotherapy ProtocolsBoronic AcidsBortezomibBreast NeoplasmsDose-Response Relationship, DrugDoxorubicinFemaleFollow-Up StudiesHumansMiddle AgedPolyethylene GlycolsPyrazinesSurvival AnalysisTreatment OutcomeBoronic AcidsBortezomibDoxorubicinliposomal doxorubicinPolyethylene GlycolsPyrazines

Identifiers

PMID21147690
PMCPMC5830095
OpenAlexW2127688249

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.