NCT05893966 Prospective Cohort for Tumor Bed Boost Radiotherapy in HER2 Positive Breast Cancer
| NCT ID | NCT05893966 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Samsung Medical Center |
| Condition | Breast Cancer |
| Study Type | OBSERVATIONAL |
| Enrollment | 400 participants |
| Start Date | 2022-11-29 |
| Primary Completion | 2030-11-29 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 400 participants in total. It began in 2022-11-29 with a primary completion date of 2030-11-29.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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
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
Contact & Investigator
Haeyoung Kim, MD, PhD
PRINCIPAL INVESTIGATOR
Samsung Medical Center
Frequently Asked Questions
Who can join the NCT05893966 clinical trial?
This trial is open to female participants only, aged 19 Years or older, studying Breast Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05893966 currently recruiting?
Yes, NCT05893966 is actively recruiting participants. Contact the research team at haeyoung0131.kim@samsung.com for enrollment information.
Where is the NCT05893966 trial being conducted?
This trial is being conducted at Seoul, South Korea.
Who is sponsoring the NCT05893966 clinical trial?
NCT05893966 is sponsored by Samsung Medical Center. The principal investigator is Haeyoung Kim, MD, PhD at Samsung Medical Center. The trial plans to enroll 400 participants.
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