Evidence map›Paper›PMID 42573832›Full record

ArticleBreast cancer research and treatment2026

Patient-reported outcomes in clinical trials leading to breast cancer drug approvals: are we making them count?

Samuel Margolis, Andre Naguib Guirguis, Catherine Lee, Saiya Smith, Alexis LeVee, Marla D Lipsyc-Sharf, Aditya Bardia, Mina S Sedrak

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In one paragraph

Article in Breast cancer research and treatment, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.

0numbers the graph read from it
0cells of the map it votes in
0citing papers in PubMed
–field-weighted citation impact
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

0 citing papers in PubMed.

No citing paper in PubMed yet.

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.

Samuel MargolisDepartment of Medicine, University of California, Los Angeles, CA, USA.
Andre Naguib GuirguisDepartment of Medicine, University of California, Los Angeles, CA, USA.
Catherine LeeDepartment of Medicine, University of California, Los Angeles, CA, USA.
Saiya SmithDepartment of Medicine, University of California, Los Angeles, CA, USA.
Alexis LeVeeDepartment of Medicine, University of California, Los Angeles, CA, USA.
Marla D Lipsyc-SharfDepartment of Medicine, University of California, Los Angeles, CA, USA.
Aditya BardiaDepartment of Medicine, University of California, Los Angeles, CA, USA.
Mina S SedrakDepartment of Medicine, University of California, Los Angeles, CA, USA. msedrak@mednet.ucla.edu.ORCID https://orcid.org/0000-0002-8379-391X

Funding

Targeting Senescence to Improve Frailty in Older Cancer SurvivorsK76AG074918 · NIA · UNIVERSITY OF CALIFORNIA LOS ANGELES · PI SEDRAK, MINA S · 2022 to 2024
$729k
NIA NIH HHS K76 AG074918
6 · The paper itself

Abstract

purposePatient-reported outcomes (PROs) inform benefit-risk tradeoffs in breast cancer treatment, yet reporting quality across registration trials remains incompletely characterized.

methodsWe conducted a scoping review of PRO reporting in randomized trials supporting FDA breast cancer drug approvals (January 2011-December 2024), identified via the FDA Oncology Approval Notifications database. Associated manuscripts were retrieved through systematic PubMed and EBSCO searches using trial-specific NCT identifiers. We assessed PRO endpoint prespecification status, instruments used, PRO publication delay (defined as the interval in months between the primary trial manuscript and corresponding PRO-dedicated manuscript publication date), and missing data reporting across eligible primary trial, PRO-dedicated, and subpopulation-specific PRO manuscripts.

resultsWe identified 34 FDA breast cancer drug approvals supported by 36 unique randomized trials, yielding 45 eligible manuscripts. No trial designated PROs as a primary or co-primary endpoint; nine (25%) did not explicitly prespecify them. Median PRO publication delay was 18 months, with eight trials experiencing a delay of two or more years. Missing data handling methods were described in 33% of manuscripts and reasons for missingness in 11%.

conclusionIn this scoping review, PROs were commonly collected but inconsistently prespecified, often delayed, and incompletely reported. Registration trials should strengthen PRO prespecification, reduce publication delay, and adhere to missing data reporting standards. CLINICAL TRIAL NUMBER: Not applicable.

Indexed as

Antineoplastic AgentsBreast NeoplasmsDrug ApprovalPatient Reported Outcome MeasuresClinical Trials as TopicFemaleHumansRandomized Controlled Trials as TopicUnited StatesUnited States Food and Drug AdministrationAntineoplastic AgentsBreast cancerClinical trialsDrug approvalPatient-reported outcomesQuality of lifeRegulatory scienceTolerabilityToxicity

Identifiers

PMID42573832
PMCPMC13457446

What OpenQuestion holds

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Registered trials

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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.