Clinical trial · Observational
Prospective Cohort for Tumor Bed Boost Radiotherapy in HER2 Positive Breast Cancer
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Whole breast irradiation +/- tumor bed boost | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Ipsilateral breast tumor recurrence
- timeFrame
- 7 years from the start of the postoperative radiation therapy
- description
- The event for ipsilateral breast tumor recurrence (IBTR) was defined as any breast tumor recurrence in irradiated breast.
Secondary outcomes (4)
- measure
- Disease-free survival
- timeFrame
- 7 years from the start of the postoperative radiation therapy
- description
- The event for disease-free survival (DFS) was defined as any local, regional, or distant recurrence or breast cancer-related death.
- measure
- Locoregional recurrence
- timeFrame
- 7 years from the start of the postoperative radiation therapy
- description
- The event for locoregional recurrence was defined as recurrence in irradiated breast / chest wall or regional lymph node area.
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 19 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available