NCT05607017

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)

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
10

participants targeted

Target at below P25 for early_phase_1 breast-cancer

Timeline
Completed

Started Jan 2024

Shorter than P25 for early_phase_1 breast-cancer

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 1, 2022

Completed
6 days until next milestone

First Posted

Study publicly available on registry

November 7, 2022

Completed
1.2 years until next milestone

Study Start

First participant enrolled

January 1, 2024

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2024

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2024

Completed
Last Updated

January 12, 2024

Status Verified

January 1, 2024

Enrollment Period

9 months

First QC Date

November 1, 2022

Last Update Submit

January 11, 2024

Conditions

Breast CancerMyocardial FibrosisRadiation-Induced Fibrosis

Keywords

Breast CancerMyocardial FibrosisRadiation-Induced Fibrosis

Outcome Measures

Primary Outcomes (1)

  • Extracellular Volume (ECV) of Myocardial Fibrosis

    The primary endpoint is detectable decrease in extracellular volume as measured by cardiac MRI

    6 months

Secondary Outcomes (1)

  • Serum cardiac biomarker

    6 months

Study Arms (1)

Radiation Therapy and Losartan

EXPERIMENTAL

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

Drug: LosartanRadiation: Radiation Therapy

Interventions

LosartanDRUG

Taken Orally

Also known as: Losartan Potassium
Radiation Therapy and Losartan
Radiation TherapyRADIATION

Photon Radiation Therapy

Radiation Therapy and Losartan

Eligibility Criteria

Age18 Years+
Sexfemale(Gender-based eligibility)
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • \>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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Massachusetts General Hospital Cancer Center

Boston, Massachusetts, 02114, United States

RECRUITING

MeSH Terms

Conditions

Breast NeoplasmsRadiation Fibrosis Syndrome

Interventions

LosartanRadiotherapy

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue DiseasesFibrosisPathologic ProcessesPathological Conditions, Signs and SymptomsRadiation InjuriesWounds and Injuries

Intervention Hierarchy (Ancestors)

Biphenyl CompoundsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsImidazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsTetrazolesTherapeutics

Study Officials

  • Rachel Jimenez, MD

    Massachusetts General Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Rachel Jimenez, MD

CONTACT

617-726-8651rbjimenez@partners.org

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

November 1, 2022

First Posted

November 7, 2022

Study Start

January 1, 2024

Primary Completion

October 1, 2024

Study Completion

December 1, 2024

Last Updated

January 12, 2024

Record last verified: 2024-01

Data Sharing

IPD Sharing
Will share

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.

Shared Documents
STUDY PROTOCOL, SAP, ICF
Time Frame
Data can be shared no earlier than 1 year following the date of publication
Access Criteria
Contact the Partners Innovations team at http://www.partners.org/innovation

Locations

US(1)