Evidence map›Paper›PMID 36001346›Full record

ArticleCancer prevention research (Philadelphia, Pa.)2022

Lessons from the Failure to Complete a Trial of Denosumab in Women With a Pathogenic BRCA1/2 Variant Scheduling Risk-Reducing Salpingo-Oophorectomy.

Meghna S Trivedi, Nadir Arber, Eitan Friedman, Judy E Garber, Kevin Holcomb, Neil S Horowitz, Jason D Wright, J Jack Lee, Lana A Vornik, Saba Abutaseh and 8 more

Open access · bronzeAbstract read
In one paragraph

Article in Cancer prevention research (Philadelphia, Pa.), 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed
0.4field-weighted citation impact, top 37% 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

2 citing papers in PubMed, 4 citations in OpenAlex.

  1. Review
  2. 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

18 authors at 7 institutions in 2 countries.

Meghna S TrivediColumbia University Irving Medical Center, New York, New York.ORCID 0000-0002-4831-0492
Nadir ArberTel Aviv Sourasky Medical Center, Tel Aviv, Israel.ORCID 0000-0001-5283-6991
Eitan FriedmanChaim Sheba Medical Center, Tel-Aviv University Medical School, Tel Aviv, Israel.ORCID 0000-0002-6745-1733
Judy E GarberDana-Farber Cancer Institute, Boston, Massachusetts.ORCID 0000-0001-9449-3982
Kevin HolcombWeill Cornell Medical Center, New York, New York.ORCID 0000-0002-6916-5271
Neil S HorowitzDana-Farber Cancer Institute, Boston, Massachusetts.ORCID 0000-0002-4854-0642
Jason D WrightColumbia University Irving Medical Center, New York, New York.ORCID 0000-0001-6390-825X
J Jack LeeUniversity of Texas MD Anderson Cancer Center, Houston, Texas.ORCID 0000-0001-5469-9214
Lana A VornikUniversity of Texas MD Anderson Cancer Center, Houston, Texas.ORCID 0000-0002-1812-0305
Saba AbutasehUniversity of Texas MD Anderson Cancer Center, Houston, Texas.ORCID 0000-0002-1016-3431
Tawana CastileUniversity of Texas MD Anderson Cancer Center, Houston, Texas.ORCID 0000-0003-0441-481X
Edward R SauterDivision of Cancer Prevention, National Cancer Institute, Rockville, Maryland.ORCID 0000-0002-8232-9146
Eileen DimondDivision of Cancer Prevention, National Cancer Institute, Rockville, Maryland.ORCID 0000-0001-7628-1783
Brandy M Heckman-StoddardDivision of Cancer Prevention, National Cancer Institute, Rockville, Maryland.ORCID 0000-0003-1686-7154
Margaret HouseDivision of Cancer Prevention, National Cancer Institute, Rockville, Maryland.ORCID 0000-0001-6887-1046
Goli SamimiDivision of Cancer Prevention, National Cancer Institute, Rockville, Maryland.ORCID 0000-0002-0674-003X
Powel H BrownUniversity of Texas MD Anderson Cancer Center, Houston, Texas.ORCID 0000-0002-3398-163X
Katherine D CrewColumbia University Irving Medical Center, New York, New York.ORCID 0000-0002-9637-2962
National Cancer Institute · USThe University of Texas MD Anderson Cancer Center · USColumbia University Irving Medical Center · USDana-Farber Cancer Institute · USNewYork–Presbyterian Hospital · USSheba Medical Center · ILTel Aviv Sourasky Medical Center · IL

Funding

PHASE I and II CLINICAL TRIALS OF CHEMOPREVENTIVE AGENTS-261035159-261035159N01CN035159 · CN · UNIVERSITY OF TEXAS M D ANDER · PI LIPPMAN, SCOTT M. · 2004 to 2006
–
NCI NIH HHS HHSN261201200034CNCI NIH HHS N01 CN035159
6 · The paper itself

Abstract

Female carriers of pathogenic/likely pathogenic (P/LP) BRCA1/2 variants are at increased risk of developing breast and ovarian cancer. Currently, the only effective strategy for ovarian cancer risk reduction is risk-reducing bilateral salpingo-oophorectomy (RR-BSO), which carries adverse effects related to early menopause. There is ongoing investigation of inhibition of the RANK ligand (RANKL) with denosumab as a means of chemoprevention for breast cancer in carriers of BRCA1 P/LP variants. Through the NCI Division of Cancer Prevention (DCP) Early Phase Clinical Trials Prevention Consortia, a presurgical pilot study of denosumab was developed in premenopausal carriers of P/LP BRCA1/2 variants scheduled for RR-BSO with the goal of collecting valuable data on the biologic effects of denosumab on gynecologic tissue. The study was terminated early due to the inability to accrue participants. Challenges which impacted the conduct of this study included a study design with highly selective eligibility criteria and requirements and the COVID-19 pandemic. It is critical to reflect on these issues to enhance the successful completion of future prevention studies in individuals with hereditary cancer syndromes.

Indexed as

Breast NeoplasmsCOVID-19Ovarian NeoplasmsBRCA1 ProteinDenosumabFemaleHumansMutationOvariectomyPandemicsPilot ProjectsSalpingo-oophorectomyBRCA1 ProteinBRCA1 protein, humanDenosumab

Identifiers

PMID36001346
PMCPMC10441620
OpenAlexW4292940376

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.