Analyzing radiation therapy outcomes in HER2 positive breast cancer
Prospective Cohort for Tumor Bed Boost Radiotherapy in HER2 Positive Breast Cancer
This study looks at how well radiation therapy works for women with HER2 positive breast cancer after they have had surgery, to see if it helps prevent cancer from coming back and to track any side effects over seven years.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 400 (estimated) |
| Ages | 19 Years and up |
| Sex | Female |
| Sponsor | Samsung Medical Center Academic / other |
| Drugs / interventions | radiation |
| Locations | 1 site (Seoul) |
| Trial ID | NCT05893966 on ClinicalTrials.gov |
What this trial studies
This observational study focuses on evaluating the treatment outcomes of postoperative radiation therapy, specifically the tumor bed boost, in female patients with HER2 positive breast cancer who have undergone breast conserving surgery. The study aims to assess various outcomes over a seven-year period, including ipsilateral breast tumor recurrence, disease-free survival, locoregional recurrence, overall survival, and adverse events related to radiation therapy. Participants will undergo multi-dimensional assessments to monitor their disease status and any side effects from the treatment.
Who should consider this trial
Good fit: Ideal candidates for this study are female patients aged 19 and older with confirmed HER2 positive invasive breast cancer who have undergone breast conserving surgery.
Not a fit: Patients with ductal carcinoma in situ or those who have previously received radiation therapy to the ipsilateral breast may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide valuable insights into optimizing radiation therapy for HER2 positive breast cancer, potentially improving patient outcomes.
How similar studies have performed: While there have been studies on radiation therapy in breast cancer, this specific focus on tumor bed boost in HER2 positive patients is relatively novel and not extensively tested.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Seoul
- Samsung Medical Center — Seoul, South Korea (Recruiting)
Study contacts
- Principal investigator: Haeyoung Kim, MD, PhD — Samsung Medical Center
- Study coordinator: Haeyoung Kim, MD, PhD
- Email: haeyoung0131.kim@samsung.com
- Phone: 82-2-3410-2612
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.