NDLI: How do breast cancer clinical trials approach cardiovascular safety: targeted or generalized?

Content Provider	Springer Nature : BioMed Central
Author	Hamid, Arsalan Fonarow, Gregg C. Butler, Javed Hall, Michael E.
Abstract	Background Different breast cancer pharmacotherapy agents cause different forms of cardiovascular toxicity. We aim to assess if breast cancer pharmacotherapy trials approach cardiovascular safety in a targeted or generalized manner when administering different agents. Methods We searched Embase and Medline for phase 2 and 3 breast cancer pharmacotherapy trials. We examined exclusion criterion for cardiovascular conditions and cardiovascular safety assessment through cardiovascular imaging, electrocardiogram, troponin, or natriuretic peptides. Fisher’s exact test was utilized to compare reporting. Results Fifty breast cancer clinical trials were included in this study. Trials administering microtubule inhibitors were most likely to exclude patients with any CV condition compared with trials administering other agents (93.5% vs. 68.4%; p < 0.05), particularly coronary artery disease (77.4% vs. 36.8%; p < 0.01) but reported performing an electrocardiogram in 13 (41.9%) trials. Trials administering anti-HER 2 agents excluded all patients with at least one CV condition, particularly patients with heart failure (100.0% vs. 62.9%) and were more likely to perform echocardiograms (80.0% vs. 22.9%, p < 0.001) compared with other agents. Other agents excluded participants in a generalized manner and do not frequently perform targeted safety assessments. Conclusions Only trials administering microtubule inhibitors or anti-HER 2 therapy exclude patients with cardiovascular disease in a targeted approach. However, anti-HER 2 therapy trials are the only breast cancer clinical trials that perform targeted safety assessments. Breast cancer clinical trials need to develop a targeted approach to cardiovascular safety assessments to permit inclusion of high-risk participants and generate clinical trial data generalizable to patients with cardiovascular disease undergoing cancer therapy.
Related Links	https://cardiooncologyjournal.biomedcentral.com/counter/pdf/10.1186/s40959-024-00201-9.pdf
Ending Page	5
Page Count	5
Starting Page	1
File Format	HTM / HTML
ISSN	20573804
DOI	10.1186/s40959-024-00201-9
Journal	Cardio-Oncology
Issue Number	1
Volume Number	10
Language	English
Publisher	BioMed Central
Publisher Date	2024-02-07
Access Restriction	Open
Subject Keyword	Oncology Cardiology Breast cancer Clinical trials Cardiovascular safety Prevent cardiotoxicity
Content Type	Text
Resource Type	Correspondence
Subject	Oncology Cardiology and Cardiovascular Medicine
Journal Impact Factor	3.2/2023

Sl.	Authority	Responsibilities	Communication Details
1	Ministry of Education (GoI), Department of Higher Education	Sanctioning Authority	https://www.education.gov.in/ict-initiatives
2	Indian Institute of Technology Kharagpur	Host Institute of the Project: The host institute of the project is responsible for providing infrastructure support and hosting the project	https://www.iitkgp.ac.in
3	National Digital Library of India Office, Indian Institute of Technology Kharagpur	The administrative and infrastructural headquarters of the project	Dr. B. Sutradhar bsutra@ndl.gov.in
4	Project PI / Joint PI	Principal Investigator and Joint Principal Investigators of the project	Dr. B. Sutradhar bsutra@ndl.gov.in Prof. Saswat Chakrabarti will be added soon
5	Website/Portal (Helpdesk)	Queries regarding NDLI and its services	support@ndl.gov.in
6	Contents and Copyright Issues	Queries related to content curation and copyright issues	content@ndl.gov.in
7	National Digital Library of India Club (NDLI Club)	Queries related to NDLI Club formation, support, user awareness program, seminar/symposium, collaboration, social media, promotion, and outreach	clubsupport@ndl.gov.in
8	Digital Preservation Centre (DPC)	Assistance with digitizing and archiving copyright-free printed books	dpc@ndl.gov.in
9	IDR Setup or Support	Queries related to establishment and support of Institutional Digital Repository (IDR) and IDR workshops	idr@ndl.gov.in

Late cardiotoxicity related to HER2-targeted cancer therapy

Rationale and design of a cardiac safety study for reduced cardiotoxicity surveillance during HER2-targeted therapy

Cardiovascular Safety Reporting in Contemporary Breast Cancer Clinical Trials.

Cardiotoxicity from neoadjuvant targeted treatment for breast cancer prior to surgery

How to Follow, Manage and Treat Cardiac Dysfunction in Patients With Her2+ Breast Cancer.

Strategies to prevent anthracycline-induced cardiotoxicity in cancer survivors

Cardiotoxicity and cardiovascular disease risk assessment for patients receiving breast cancer treatment

Cardiovascular Safety Assessment in Cancer Drug Development.

Trastuzumab in patients with breast cancer and pre-existing left ventricular systolic dysfunction

How do breast cancer clinical trials approach cardiovascular safety: targeted or generalized?

Similar Documents

Late cardiotoxicity related to HER2-targeted cancer therapy

Rationale and design of a cardiac safety study for reduced cardiotoxicity surveillance during HER2-targeted therapy

Cardiovascular Safety Reporting in Contemporary Breast Cancer Clinical Trials.

Cardiotoxicity from neoadjuvant targeted treatment for breast cancer prior to surgery

How to Follow, Manage and Treat Cardiac Dysfunction in Patients With Her2+ Breast Cancer.

Strategies to prevent anthracycline-induced cardiotoxicity in cancer survivors

Cardiotoxicity and cardiovascular disease risk assessment for patients receiving breast cancer treatment

Cardiovascular Safety Assessment in Cancer Drug Development.

Trastuzumab in patients with breast cancer and pre-existing left ventricular systolic dysfunction

How do breast cancer clinical trials approach cardiovascular safety: targeted or generalized?