Clinical trial · Interventional
A Randomized Trial of Five Fraction Partial Breast Irradiation (RAPID2)
A Randomized Trial of Five-Fraction Partial Breast Irradiation (RAPID2)
NCT05417516CI-TRIAL-00116966recruitingPhase 3ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 15, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260915-000001
Summary
Brief summary (as posted)
The primary objective of this study is to determine in women with node negative BC ≤3cm in size, if PBI compared to WBI, both given once-a-day over 1 week following BCS, is non-inferior for LR and reduces adverse cosmesis. The primary outcomes are LR and patient-assessed cosmesis at 3 years post randomization.
Conditions
Conditions (3)
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 Neoplasm Female | — | UNRESOLVED | — |
| Cosmetic Outcome | — | UNRESOLVED | — |
| Radiotherapy | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Partial Breast Irradiation (PBI) | Radiation | — | UNRESOLVED |
| Whole Breast Irradiation (WBI) | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Whole Breast Irradiation (WBI)
- description
- 26 Gy in 5 fractions to the whole breast
- interventionNames
- Radiation: Whole Breast Irradiation (WBI)
- type
- EXPERIMENTAL
- label
- Partial Breast Irradiation (PBI)
- description
- 26 Gy in 5 fractions to the tumour bed with a margin of normal tissue
- interventionNames
- Radiation: Partial Breast Irradiation (PBI)
Primary outcomes (2)
- measure
- Local Recurrence
- timeFrame
- Annually for 5 years post-randomization
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 50 Years
- Maximum age
- 120 Years
Show eligibility criteria text
Inclusion Criteria: For inclusion in this study, patients must fulfill all of the following criteria: 1. Female with a new histological diagnosis of invasive carcinoma of the breast with no evidence of metastatic disease (see AJCC TNM Cancer Staging, Appendix II). 2. Treated by BCS with microscopically clear resection margins \>= 1mm for invasive and non-invasive disease or no residual disease on re-excision. 3. Negative axillary node involvement as determined by either sentinel lymph node biopsy or axillary node dissection or clinical assessment with a negative axillary ultrasound and/or biopsy, for women with unifocal tumours \<= 2cm, histologic grade 1 or 2, ER or PR+ and HER2-ve that are being planned for endocrine therapy Exclusion Criteria: Patients who satisfy any of the following exclusion criteria are NOT eligible for this study: 1. Age less than 50 years. 2. Known to be BRCA 1 and/or BRCA 2 positive. 3. Tumour size \>3cm in greatest diameter on pathological examination. 4. Evidence of extensive intraductal component (EIC) (defined as an invasive tumour with a ductal carcinoma in situ (DCIS) component comprising at least 25% and extending beyond the invasive component to surrounding normal breast tissue) with the following exception: smaller tumours with EIC where the combined size (of the invasive and DCIS components) are \<= 3cm remain eligible 5. Evidence of a DCIS component \> 3cm 6. Lobular carcinoma only. 7. More than one primary tumour in different quadrants of the same breast (patients with multifocal breast cancer are eligible). 8. Synchronous or previous contralateral breast cancer (patients with contralateral DCIS or LCIS are eligible). 9. History of non-breast malignancy within the last 5 years other than treated non-melanoma skin cancer or treated in-situ carcinoma. 10. Known pregnancy or currently lactating. 11. Inability to localize tumour bed on CT planning (no evidence of surgical clips or seroma). 12. Inability to plan the patient for the experimental technique.
References
Publications (0)
Data not yet available
No reference posted for this study.