Evidence map›Paper›PMID 31570268›Full record

ArticleClinical breast cancer2020

Phase 1 Study of Erlotinib and Metformin in Metastatic Triple-Negative Breast Cancer.

Kathleen Fenn, Matthew Maurer, Shing M Lee, Katherine D Crew, Meghna S Trivedi, Melissa K Accordino, Dawn L Hershman, Kevin Kalinsky

Open access · greenAbstract readClinical Trial, Phase I
In one paragraph

Article in Clinical breast cancer, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 22 papers.

0numbers the graph read from it
0cells of the map it votes in
22citing papers in PubMed
1.5field-weighted citation impact, top 17% 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

22 citing papers in PubMed, 33 citations in OpenAlex.

  1. Trial
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  11. Role of EGFR and FASN in breast cancer progression.Journal of cell communication and signaling · 2023
    Review
  12. Review
  13. Article
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  15. Article
  16. Article
  17. Article
  18. Metformin and Cancer, an Ambiguanidous Relationship.Pharmaceuticals (Basel, Switzerland) · 2022
    Review
  19. RETRACTED: Metformin and Breast Cancer: Where Are We Now?International journal of molecular sciences · 2022
    Review
  20. Article
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

8 authors at 3 institutions in 1 country.

Kathleen FennDepartment of Medicine, Columbia University Irving Medical Center, New York NY.
Matthew MaurerBristol-Myers Squibb, Princeton, NJ.
Shing M LeeDepartment of Biostatistics, Mailman School of Public Health, Columbia University, New York, NY.
Katherine D CrewDepartment of Medicine, Columbia University Irving Medical Center, New York NY.
Meghna S TrivediDepartment of Medicine, Columbia University Irving Medical Center, New York NY.
Melissa K AccordinoDepartment of Medicine, Columbia University Irving Medical Center, New York NY.
Dawn L HershmanDepartment of Medicine, Columbia University Irving Medical Center, New York NY.
Kevin KalinskyDepartment of Medicine, Columbia University Irving Medical Center, New York NY. Electronic address: kk2693@columbia.edu.
Columbia University Irving Medical Center · USBristol-Myers Squibb (United States) · USColumbia University · US

Funding

Institutional Career Development CoreKL2TR001874 · NCATS · COLUMBIA UNIVERSITY HEALTH SCIENCES · PI GENKINGER, JEANINE M., SHIMBO, DAICHI · 2016 to 2025
$13.6M
Molecular Oncology Training ProgramT32CA203703 · NCI · COLUMBIA UNIVERSITY HEALTH SCIENCES · PI Katherine D Crew, DAWN HERSHMAN · 2016 to 2026
$4.1M
NCATS NIH HHS KL2 TR001874NCI NIH HHS T32 CA203703
6 · The paper itself

Abstract

backgroundEpidermal growth factor receptor (EGFR) is frequently overexpressed in metastatic triple-negative breast cancer (mTNBC). One strategy for overcoming resistance to EGFR inhibition is concomitant inhibition of downstream signaling. The antidiabetic drug metformin inhibits both MAPK and PI3K/mTOR pathway signaling. We evaluated the combination of erlotinib and metformin in a phase 1 study of patients with mTNBC. PATIENTS AND

methodsPatients with mTNBC who had received at least one prior line of therapy for metastatic disease were eligible. Erlotinib dose was fixed at 150 mg daily. Metformin dose escalation was planned according to a 3 + 3 design. Dose-limiting toxicities (DLT) were assessed during the first 5 weeks of therapy. The primary objective was to determine the maximum tolerated dose of metformin with fixed-dose erlotinib. Secondary endpoints were response rate, stable disease rate, and progression-free survival.

resultsEight patients were enrolled. The median number of prior therapies for metastatic disease was 2.5 (range, 1-6). No DLT events were reported during the DLT assessment period. Most adverse events were grade 1/2. Grade 3 diarrhea despite maximum supportive care required dose reduction of metformin in one patient. Grade 3 rash led to study withdrawal in one patient. No grade 4 adverse events were reported. The best observed response was stable disease in 2 patients (25%). Median progression-free survival was 60 days (range, 36-61 days).

conclusionErlotinib and metformin were well tolerated in a population of pretreated mTNBC patients but did not demonstrate efficacy in this population.

Indexed as

AdultAgedAntineoplastic Combined Chemotherapy ProtocolsBreastDose-Response Relationship, DrugErbB ReceptorsErlotinib HydrochlorideFemaleHumansMAP Kinase Signaling SystemMaximum Tolerated DoseMetforminMiddle AgedProgression-Free SurvivalTOR Serine-Threonine KinasesTriple Negative Breast NeoplasmsEGFR protein, humanErbB ReceptorsErlotinib HydrochlorideMetforminMTOR protein, humanTOR Serine-Threonine KinasesCombination therapyEGFRMetastatic breast cancerPhase I studyTargeted therapy

Identifiers

PMID31570268
PMCPMC7304226
OpenAlexW2970900127

What OpenQuestion holds

Textmetadata
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.