NCT02942615

Brief Summary

This trial is to explore the optimal strategies for guaranteeing the cardiac safety of breast cancer patients following adjuvant radiotherapy in the modern era of multidisciplinary treatment.

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
220

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jun 2017

Longer than P75 for not_applicable

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

October 19, 2016

Completed
5 days until next milestone

First Posted

Study publicly available on registry

October 24, 2016

Completed
8 months until next milestone

Study Start

First participant enrolled

June 27, 2017

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 8, 2020

Completed
5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2025

Completed
Last Updated

December 29, 2022

Status Verified

December 1, 2022

Enrollment Period

3.3 years

First QC Date

October 19, 2016

Last Update Submit

December 27, 2022

Conditions

Breast NeoplasmsCardiotoxicity

Outcome Measures

Primary Outcomes (1)

  • cardiac toxicity event free survival

    The time from the date of randomization to any recurrence of clinical or subclinical cardiac toxicity

    1 year

Secondary Outcomes (17)

  • cardiac toxicity event free survival

    5 years

  • cardiac toxicity event free survival

    10 years

  • overall survival

    5 years

  • overall survival

    10 years

  • relative change of value of serum cardiac biomarkers of creatine kinase (CK)-MB

    1 year

  • +12 more secondary outcomes

Study Arms (2)

Heart safety management

EXPERIMENTAL

limit heart dose more frequent follow up of cardiac function professional management of cardiac toxicity

Other: limit heart dose

Control group

NO INTERVENTION

without any restrict heart dose limitation for RT Follow up of cardiac function Observation and without any special management of cardiac toxicity

Interventions

limit heart doseOTHER

limit heart dose: Dmean≤6Gy,V30≤20%,V10≤50%

Also known as: frequently follow of cardiac function, management of cardiotoxicity
Heart safety management

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients willing to participate the research and sign the informed consent file;
  • Patients aged 18-80 years;
  • KPS≥70;
  • Pathological diagnosis for invasive breast cancer;
  • Patients received anthracycline/paclitaxel based chemotherapy, or herceptin based targeted therapy;
  • No functional heart disease;
  • LVEF≥50%;
  • Patients received breast conserving surgery;
  • Patients received modified radical mastectomy: T1-2 with N1-3 or T3-4 with any N;
  • Tumor margin negative;
  • No metastases;
  • No other malignant tumor history.

You may not qualify if:

  • Patients with metastases;
  • Tumor margin positive;
  • Patients received modified radical mastectomy with T1-2 and N0;
  • Patients have other malignant tumor;
  • Patients have a history of heart disease;
  • Patients received chest radiotherapy previously;
  • Patients with severe organic and functional disease;
  • Unqualified patients with sufficient reasons;
  • Cannot or no willing to sign the informed consent file;
  • Patients with autoimmune disease;
  • Women with pregnancy, planned pregnancy or lactating.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ruijin Hospital, Shanghai Jiaotong University School of Medicine

Shanghai, Shanghai Municipality, 200025, China

Location

MeSH Terms

Conditions

Breast NeoplasmsCardiotoxicity

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue DiseasesHeart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and SymptomsDrug-Related Side Effects and Adverse ReactionsChemically-Induced DisordersRadiation InjuriesWounds and Injuries

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SCREENING
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Chief of department of radiation oncology

Study Record Dates

First Submitted

October 19, 2016

First Posted

October 24, 2016

Study Start

June 27, 2017

Primary Completion

October 8, 2020

Study Completion

October 1, 2025

Last Updated

December 29, 2022

Record last verified: 2022-12

Locations

CN(1)