Ireland
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Recruiting Observational

Prospective Cohort for Tumor Bed Boost Radiotherapy in HER2 Positive Breast Cancer

NCT05893966 · tracked via the Priya Life Science South Korea tracker
Phase
Observational
Started
2022-11-29
Last updated
2026-08-10

Condition(s) studied

Breast Cancer

Investigational drug(s) / intervention(s)

Whole breast irradiation +/- tumor bed boost

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)

Study 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

Sex
FEMALE
Min age
19 Years
Max age
—
Healthy volunteers
No
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

Primary outcome measure(s)

  • Ipsilateral breast tumor recurrence — 7 years from the start of the postoperative radiation therapy
    The event for ipsilateral breast tumor recurrence (IBTR) was defined as any breast tumor recurrence in irradiated breast.

Trial sites (1)

FacilityCityRegionStatus
Samsung Medical Center Seoul Seoul Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05893966 on ClinicalTrials.gov ↗ ← All trials in South Korea