NCT05200078

Brief Summary

Postoperative breast radiotherapy (RT) has been associated with increased risk of heart toxicity. However, there is a lack of knowledge for radiation-induced early cardiovascular injury, especially for hypofractionated RT. This study aims to prospectively detect and predict early clinical or subclinical cardiac events in women undergoing adjuvant RT for breast cancer.

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
166

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Sep 2021

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

Study Start

First participant enrolled

September 1, 2021

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

December 13, 2021

Completed
1 month until next milestone

First Posted

Study publicly available on registry

January 20, 2022

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2022

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2023

Completed
Last Updated

January 20, 2022

Status Verified

January 1, 2022

Enrollment Period

10 months

First QC Date

December 13, 2021

Last Update Submit

January 6, 2022

Conditions

Breast CancerCardiac Event

Outcome Measures

Primary Outcomes (1)

  • Incidence of clinical or subclinical cardiac injury

    predefined cardiac events

    two years

Study Arms (2)

Radiotherapy at free-breathing

breast/chest wall+-RNI 43.5Gy/15f/3w（tumor bed 49.5Gy/15f/3w) delivered at free-breathing

Radiotherapy at deep inspiration breath-hold

breast/chest wall+-RNI 43.5Gy/15f/3w（tumor bed 49.5Gy/15f/3w) delivered at deep inspiration breath-hold

Device: Deep inspiration breath-hold technique

Interventions

Deep inspiration breath-hold techniqueDEVICE

Selective application of deep inspiration breath-hold technique

Radiotherapy at deep inspiration breath-hold

Eligibility Criteria

Age18 Years - 70 Years
Sexfemale
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

women with left-sided breast cancer planning for adjuvant radiotherapy

You may qualify if:

  • Primary left-sided breast cancer post surgery
  • Planning for adjuvant breast/chest wall +-RNI

You may not qualify if:

  • History of cardiovascular disease
  • Previous chest radiation
  • Bilateral breast cancers

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cancer Hospital, Chinese Academy of Medical Sciences

Beijing, 100021, China

RECRUITING

MeSH Terms

Conditions

Breast NeoplasmsCardiovascular Diseases

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Central Study Contacts

Shu-Lian Wang

CONTACT

86-13366191993wangsl@cicams.ac.cn

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
UNKNOWN
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

December 13, 2021

First Posted

January 20, 2022

Study Start

September 1, 2021

Primary Completion

June 30, 2022

Study Completion

June 30, 2023

Last Updated

January 20, 2022

Record last verified: 2022-01

Locations

CN(1)