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Losartan in Prevention of Radiation-Induced Heart Failure

Primary Purpose

Breast Cancer, Myocardial Fibrosis, Radiation-Induced Fibrosis

Status
Not yet recruiting
Phase
Early Phase 1
Locations
United States
Study Type
Interventional
Intervention
Losartan
Radiation Therapy
Sponsored by
Massachusetts General Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Breast Cancer focused on measuring Breast Cancer, Myocardial Fibrosis, Radiation-Induced Fibrosis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria: ->18 years of age Non-metastatic Breast Cancer patients who are scheduled to receive conventional left breast/chest wall RT inclusive of treatment to the internal mammary lymph nodes (IMNs) Prior chemotherapy is permitted Patients must have Left-sided Breast Cancer Ability to understand and the willingness to sign a written informed consent document No contraindication to MRI Exclusion Criteria: Person who is pregnant or breastfeeding. Patient unable to swallow oral medication. Patients receiving any other investigational agent will not be excluded from study eligibility, unless the patient is already enrolled in an interventional study evaluating cardiac toxicity Patients already receiving ACE/ARBs. Patients with a history of allergic reactions to Losartan biosimilars.

Sites / Locations

  • Massachusetts General Hospital Cancer Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Radiation Therapy and Losartan

Arm Description

Participants will receive radiation therapy 5x weekly over 1-6 weeks. Participants will receive Losartan 1x daily during radiation therapy and for up to 6 months afterward then be followed for 1 year

Outcomes

Primary Outcome Measures

Extracellular Volume (ECV) of Myocardial Fibrosis
The primary endpoint is detectable decrease in extracellular volume as measured by cardiac MRI

Secondary Outcome Measures

Serum cardiac biomarker
The secondary objective of this study is to compare pre- and post-Radiation Therapy changes in serum TGF-β levels

Full Information

First Posted
November 1, 2022
Last Updated
September 15, 2023
Sponsor
Massachusetts General Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05607017
Brief Title
Losartan in Prevention of Radiation-Induced Heart Failure
Official Title
The Role of Losartan in the Prevention of Early Structural Changes Associated With Radiation-Induced Heart Failure
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
October 15, 2023 (Anticipated)
Primary Completion Date
October 1, 2024 (Anticipated)
Study Completion Date
December 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Massachusetts General Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
This study is being done to see if losartan affects the chances of developing radiation-induced heart failure in patients who are receiving radiation therapy as part of standard of care treatment for breast cancer. The interventions involved in this study are: Losartan Radiation Therapy (standard of care)
Detailed Description
This is a pilot study examining whether losartan prevents radiation therapy-induced myocardial fibrosis (thickening of the heart tissue), which can cause heart failure, in breast cancer patients receiving radiation therapy. Losartan is an U.S. Food and Drug Administration (FDA) approved drug used to treat hypertension (high blood pressure) and heart failure. The U.S. Food and Drug Administration (FDA) has not approved losartan for use in the treatment of breast cancer. The FDA has approved radiation therapy as a treatment option for breast cancer. The research study procedures include: screening for eligibility and study treatment including evaluations and follow up visits. It is expected participants will be on the study for 1 year. It is expected that about 10 people will take part in this research study.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer, Myocardial Fibrosis, Radiation-Induced Fibrosis
Keywords
Breast Cancer, Myocardial Fibrosis, Radiation-Induced Fibrosis

7. Study Design

Primary Purpose
Treatment
Study Phase
Early Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Radiation Therapy and Losartan
Arm Type
Experimental
Arm Description
Participants will receive radiation therapy 5x weekly over 1-6 weeks. Participants will receive Losartan 1x daily during radiation therapy and for up to 6 months afterward then be followed for 1 year
Intervention Type
Drug
Intervention Name(s)
Losartan
Other Intervention Name(s)
Losartan Potassium
Intervention Description
Taken Orally
Intervention Type
Radiation
Intervention Name(s)
Radiation Therapy
Intervention Description
Photon Radiation Therapy
Primary Outcome Measure Information:
Title
Extracellular Volume (ECV) of Myocardial Fibrosis
Description
The primary endpoint is detectable decrease in extracellular volume as measured by cardiac MRI
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Serum cardiac biomarker
Description
The secondary objective of this study is to compare pre- and post-Radiation Therapy changes in serum TGF-β levels
Time Frame
6 months

10. Eligibility

Sex
Female
Gender Based
Yes
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: ->18 years of age Non-metastatic Breast Cancer patients who are scheduled to receive conventional left breast/chest wall RT inclusive of treatment to the internal mammary lymph nodes (IMNs) Prior chemotherapy is permitted Patients must have Left-sided Breast Cancer Ability to understand and the willingness to sign a written informed consent document No contraindication to MRI Exclusion Criteria: Person who is pregnant or breastfeeding. Patient unable to swallow oral medication. Patients receiving any other investigational agent will not be excluded from study eligibility, unless the patient is already enrolled in an interventional study evaluating cardiac toxicity Patients already receiving ACE/ARBs. Patients with a history of allergic reactions to Losartan biosimilars.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Rachel Jimenez, MD
Phone
617-726-8651
Email
rbjimenez@partners.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rachel Jimenez, MD
Organizational Affiliation
Massachusetts General Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Massachusetts General Hospital Cancer Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rachel Jimenez, MD
Phone
617-726-8651
Email
RBJIMENEZ@PARTNERS.ORG
First Name & Middle Initial & Last Name & Degree
Rachel Jimenez, MD

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
The Dana-Farber / Harvard Cancer Center encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to: [contact information for Sponsor Investigator or designee]. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.
IPD Sharing Time Frame
Data can be shared no earlier than 1 year following the date of publication
IPD Sharing Access Criteria
Contact the Partners Innovations team at http://www.partners.org/innovation

Learn more about this trial

Losartan in Prevention of Radiation-Induced Heart Failure

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