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Trial Title:
Prospective Cohort for Tumor Bed Boost Radiotherapy in HER2 Positive Breast Cancer
NCT ID:
NCT05893966
Condition:
Breast Cancer
Conditions: Official terms:
Breast Neoplasms
Study type:
Observational
Overall status:
Recruiting
Study design:
Time perspective:
Prospective
Intervention:
Intervention type:
Radiation
Intervention name:
Whole breast irradiation +/- tumor bed boost
Description:
Postoperative whole breast irradiation (3D-conformal radiation therapy or IMRT) with or
without tumor bed boost (sequential or simultaneous integrated boost)
Summary:
The purpose of this study is to analyze treatment outcomes related to tumor bed boost of
postoperative radiation therapy in patient with HER2+ breast cancer who underwent breast
conserving surgery.
The main questions it aims to answer are:
- 7-year ipsilateral breast tumor recurrence
- 7-year disease-free survival
- 7-year locoregional recurrence
- 7-year overall survival
- Adverse events of radiation therapy
Participants will be assessed by multi-dimensional methods after radiation therapy:
- Assessment for the disease status (disease-free or recurrence) including physical
and radiologic examination
- Assessment for the adverse events according to CTCAE version 5.0
Criteria for eligibility:
Study pop:
Any HER2+ invasive breast cancer patient with eligible performance except previous
history of radiation therapy to ipsilateral breast
Sampling method:
Non-Probability Sample
Criteria:
Inclusion Criteria:
- Female patients with age minimum 19
- Pathological confirmation of HER2+ invasive breast cancer
- Eastern Cooperative Oncology Group performance status 0-2
- Informed consent of the participant
Exclusion Criteria:
- Pathological confirmation of ductal carcinoma in situ of the breast
- Previous history of radiation therapy to ipsilateral breast
Gender:
Female
Minimum age:
19 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Samsung Medical Center
Address:
City:
Seoul
Zip:
06351
Country:
Korea, Republic of
Status:
Recruiting
Contact:
Last name:
Haeyoung Kim, MD, PhD
Phone:
82-2-3410-2612
Email:
haeyoung0131.kim@samsung.com
Start date:
November 29, 2022
Completion date:
November 29, 2032
Lead sponsor:
Agency:
Samsung Medical Center
Agency class:
Other
Source:
Samsung Medical Center
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05893966
