Evidence map›Paper›PMID 36441436›Full record

Trial reportInvestigational new drugs2023

An open label phase II study of safety and clinical activity of naltrexone for treatment of hormone refractory metastatic breast cancer.

Jayanthi Vijayakumar, Tufia Haddad, Kalpna Gupta, Janet Sauers, Douglas Yee

Registry-linked trialOpen access · hybridFull text readClinical Trial, Phase II
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Investigational new drugs, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00379197 (Phase II Study of Naltrexone for the Treatment of Hormone-Refractory, Metastatic Breast Cancer), which is not on this map. Cited by 3 papers.

0numbers the graph read from it
0cells of the map it votes in
3citing papers in PubMed
1.2field-weighted citation impact, top 20% 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.

NCT00379197 phase2terminatednot on this map

Phase II Study of Naltrexone for the Treatment of Hormone-Refractory, Metastatic Breast Cancer

TypeinterventionalSponsorMasonic Cancer Center, University of MinnesotaRan2006 to 2013Enrolled13ConditionsBreast CancerArmsnaltrexone, PET scan
3 · Its place in the literature

Who cites it

3 citing papers in PubMed, 10 citations in OpenAlex.

  1. Review
  2. Review
  3. 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

5 authors at 3 institutions in 1 country.

Jayanthi VijayakumarDivision of Hematology Oncology and Transplantation Department of Medicine, University of Minnesota, MN, Minneapolis, USA.
Tufia HaddadMayo Clinic Cancer Center, MN, Rochester, USA.
Kalpna GuptaDivision of Hematology Oncology and Transplantation Department of Medicine, University of Minnesota, MN, Minneapolis, USA.
Janet SauersMasonic Cancer Center, University of Minnesota, Minneapolis, MN, USA.
Douglas YeeDivision of Hematology Oncology and Transplantation Department of Medicine, University of Minnesota, MN, Minneapolis, USA. yeexx006@umn.edu.ORCID http://orcid.org/0000-0002-3387-4009
University of Minnesota · USMayo Clinic in Arizona · USUniversity of Minnesota Medical Center · US

Funding

Women's CancerP30CA077598 · NCI · UNIVERSITY OF MINNESOTA TWIN CITIES · PI Jeffrey S. Miller · 1998 to 2026
$100.4M
NCI NIH HHS P30 CA077598
6 · The paper itself

Abstract

The opioid receptor (OR) antagonist naltrexone inhibits estrogen receptor-α (ER) function in model systems. The goal of this study was to determine the clinical activity of naltrexone in patients with ER-positive metastatic breast cancer. Patients with hormone receptor positive metastatic breast cancer were enrolled on a phase II study of naltrexone. An escalating dose scheme was used to reach the planned dose of 50 mg daily. The primary objective of the study was to evaluate response to therapy as measured by stabilization or reduction of the tumor Maximum Standardized Uptake Value (SUVmax) at 4 weeks by PET-CT scan. The secondary objectives included safety assessment and tumor SUVmax at 8 weeks. Out of 13 patients we enrolled, 8 patients had serial PET-CT scans that were evaluable for response. Of these 8 patients, 5 had stable or decreased SUVmax values at 4 weeks and 3 had clinical or imaging progression. Median time to progression was short at 7 weeks. Naltrexone was well tolerated. There were no discontinuations due to toxicity and no grade 3 or 4 toxicities were noted. Naltrexone showed modest activity in this short study suggesting the contribution of opioid receptors in ER-positive breast cancer. Our data do not support further development of naltrexone in hormone refractory breast cancer. It is possible that more potent peripherally acting OR antagonists may have a greater effect. (ClinicalTrials.gov Identifier: NCT00379197 September 21, 2006).

Indexed as

Breast NeoplasmsFemaleHormonesHumansNaltrexonePositron Emission Tomography Computed TomographyReceptors, EstrogenHormonesNaltrexoneReceptors, EstrogenBreast cancerEstrogen receptorMu-opioid receptorNaltrexonePositron emission tomography

Identifiers

PMID36441436
PMCPMC10030534
OpenAlexW4310154284

What OpenQuestion holds

Textfull text, public
LicenceCC BY
measurements read26
identifiers read2
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.