Breast Cancer
Conditions
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
Interventions
RADIATIONWhole 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)
Sponsors
Samsung Medical Center
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
19 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Disease-free survival | 7 years from the start of the postoperative radiation therapy | The event for disease-free survival (DFS) was defined as any local, regional, or distant recurrence or breast cancer-related death. |
| Locoregional recurrence | 7 years from the start of the postoperative radiation therapy | The event for locoregional recurrence was defined as recurrence in irradiated breast / chest wall or regional lymph node area. |
| Overall survival | 7 years from the start of the postoperative radiation therapy | The event for overall survival (OS) was defined as death of any cause. |
| Adverse events | 7 years from the start of the postoperative radiation therapy | Adverse events were evaluated and graded according to CTCAE version 5.0. |
Countries
South Korea
Contacts
CONTACTHaeyoung Kim, MD, PhD
PRINCIPAL_INVESTIGATORHaeyoung Kim, MD, PhD
Samsung Medical Center
Outcome results
None listed