Evidence map›Paper›PMID 39605014›Full record

ArticleCardio-oncology (London, England)2024

A strain-guided trial of cardioprotection in early-stage breast cancer patients on anti-HER2 therapy (PROTECT HER2).

Fei Fei Gong, Eli Grunblatt, Woo Bin Voss, Vibhav Rangarajan, Sasan Raissi, Kimberly Chow, Lua Jafari, Nikita P Patel, Inga Vaitenas, Milica Marion and 8 more

Registry-linked trialAbstract read
In one paragraph

Article in Cardio-oncology (London, England), 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02993198 (A Prospective Study of Early Stage Breast Cancer Patients With Abnormal Myocardial Deformation Treated With Anthracycline and/or Trastuzumab and Pertuzumab-based Cancer Therapy), which is not on this map. Cited by 4 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
4citing papers in PubMed, 1 pooled it
–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.

NCT02993198 phase2unknown statusnot on this map

A Prospective Study of Early Stage Breast Cancer Patients With Abnormal Myocardial Deformation Treated With Anthracycline and/or Trastuzumab and Pertuzumab-based Cancer Therapy

TypeinterventionalSponsorNorthwestern UniversityRan2015 to 2025Enrolled134ConditionsHER2 Positive Breast Cancer, Cardiovascular AbnormalitiesArmsCarvedilol
3 · Its place in the literature

Who cites it

4 citing papers in PubMed, 1 synthesis or guideline pooled it.

  1. Guideline
  2. Article
  3. Review
  4. 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.

Fei Fei GongDivision of Cardiovascular Medicine, Department of Medicine, Feinberg School of Medicine, Northwestern University, 676 N. St. Clair, Suite 600, Chicago, IL, 60611, USA.
Eli GrunblattDepartment of Medicine, Feinberg School of Medicine, Northwestern University, 676 N. St. Clair, Suite 2330, Chicago, IL, 60611, USA.
Woo Bin VossDivision of Cardiovascular Medicine, Department of Medicine, Feinberg School of Medicine, Northwestern University, 676 N. St. Clair, Suite 600, Chicago, IL, 60611, USA.
Vibhav RangarajanDivision of Cardiovascular Medicine, Department of Medicine, Feinberg School of Medicine, Northwestern University, 676 N. St. Clair, Suite 600, Chicago, IL, 60611, USA.
Sasan RaissiDivision of Cardiovascular Medicine, Department of Medicine, Feinberg School of Medicine, Northwestern University, 676 N. St. Clair, Suite 600, Chicago, IL, 60611, USA.
Kimberly ChowDepartment of Medicine, Feinberg School of Medicine, Northwestern University, 676 N. St. Clair, Suite 2330, Chicago, IL, 60611, USA.
Lua JafariDepartment of Medicine, Feinberg School of Medicine, Northwestern University, 676 N. St. Clair, Suite 2330, Chicago, IL, 60611, USA.
Nikita P PatelDepartment of Medicine, Feinberg School of Medicine, Northwestern University, 676 N. St. Clair, Suite 2330, Chicago, IL, 60611, USA.
Inga VaitenasDivision of Cardiovascular Medicine, Department of Medicine, Feinberg School of Medicine, Northwestern University, 676 N. St. Clair, Suite 600, Chicago, IL, 60611, USA.
Milica MarionDivision of Cardiovascular Medicine, Department of Medicine, Feinberg School of Medicine, Northwestern University, 676 N. St. Clair, Suite 600, Chicago, IL, 60611, USA.
Haydee RamirezDivision of Cardiovascular Medicine, Department of Medicine, Feinberg School of Medicine, Northwestern University, 676 N. St. Clair, Suite 600, Chicago, IL, 60611, USA.
Manyun ZhaoDivision of Cardiovascular Medicine, Department of Medicine, Feinberg School of Medicine, Northwestern University, 676 N. St. Clair, Suite 600, Chicago, IL, 60611, USA.
Adin-Christian AndreiDivision of Cardiovascular Medicine, Department of Medicine, Feinberg School of Medicine, Northwestern University, 676 N. St. Clair, Suite 600, Chicago, IL, 60611, USA.
Abigail S BaldridgeDivision of Cardiovascular Medicine, Department of Medicine, Feinberg School of Medicine, Northwestern University, 676 N. St. Clair, Suite 600, Chicago, IL, 60611, USA.
Gillian MurtaghAbbott Laboratories, 675 N. Field Drive, Lake Forest, IL, 60045, USA.
Kameswari MagantiDivision of Cardiovascular Medicine, Department of Medicine, Feinberg School of Medicine, Northwestern University, 676 N. St. Clair, Suite 600, Chicago, IL, 60611, USA.
Vera H RigolinDivision of Cardiovascular Medicine, Department of Medicine, Feinberg School of Medicine, Northwestern University, 676 N. St. Clair, Suite 600, Chicago, IL, 60611, USA.
Nausheen AkhterDivision of Cardiovascular Medicine, Department of Medicine, Feinberg School of Medicine, Northwestern University, 676 N. St. Clair, Suite 600, Chicago, IL, 60611, USA. n-akhter@northwestern.edu.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundGlobal longitudinal strain (GLS) has been used to identify patients at risk for cancer-therapy related cardiac dysfunction (CTRCD). However, there is limited data on the effectiveness of initiating cardioprotective therapy based on a strain-guided strategy in early stage HER2+ breast cancer patients. This randomized clinical trial assessed if treatment with carvedilol based on a strain-guided strategy can prevent development of CTRCD in HER2+ breast cancer patients on non-anthracycline based regimens.

methodsStudy participants were prospectively assigned to one of four arms. Patients with normal LVEF and GLS remained in Arm A. Patients whose GLS decreased by > 15% from baseline or to < -15% during follow up were randomized 1:1 to prophylactic carvedilol (Arm B) or no therapy (Arm C). Patients who developed CTRCD were assigned to Arm D. The primary endpoint was GLS stability. The secondary endpoints were development of CTRCD and rate of anti-HER2 treatment interruption.

resultsAmong 110 patients who completed follow up, 84 were assigned to Arm A, 10 each were randomized to Arms B or C, and 6 were assigned to Arm D. At the end of the study period, there were no significant differences in GLS stability, development of CTRCD, or number of cancer therapy cycles completed between patients who did and did not receive cardioprotective therapy.

conclusionsIn this prospective randomized GLS-guided study of prophylactic carvedilol in early stage HER2+ breast cancer patients on non-anthracycline regimens, there were no significant difference between groups in GLS stability, CTRCD or trastuzumab cycles held. These findings may identify a low-risk group of patients who may be considered for less intensive cardiac surveillance.

trial registrationhttps://clinicaltrials.gov/study/NCT02993198 . Start date: 4/2015. This trial included patients who were retrospectively registered.

Indexed as

Cardioprotective therapyCTRCDGlobal longitudinal strainHER2+ breast cancer

Identifiers

PMID39605014
PMCPMC11600554

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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.