Prospective Cohort for Tumor Bed Boost Radiotherapy in HER2 Positive Breast Cancer
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Whole breast irradiation +/- tumor bed boost.
- Who it may be relevant to
- Registry conditions: Breast Cancer. Basic parameters: from 19 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- South Korea
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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
Interventions
- Radiation Whole breast irradiation +/- tumor bed boost
Postoperative whole breast irradiation (3D-conformal radiation therapy or IMRT) with or without tumor bed boost (sequential or simultaneous integrated boost)
Primary outcome measures
- Ipsilateral breast tumor recurrence [Time frame: 7 years from the start of the postoperative radiation therapy]
Secondary outcome measures (4)
- Disease-free survival [Time frame: 7 years from the start of the postoperative radiation therapy]
- Locoregional recurrence [Time frame: 7 years from the start of the postoperative radiation therapy]
- Overall survival [Time frame: 7 years from the start of the postoperative radiation therapy]
- Adverse events [Time frame: 7 years from the start of the postoperative radiation therapy]
Eligibility 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
South Korea · 1 center
- Samsung Medical Center — Seoul
Identifiers
NCT: NCT05893966 · 2022-11-018