Recruiting
A Randomized Trial of Five Fraction Partial Breast Irradiation (RAPID2)
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.
ClinicalTrials.gov IDNCT05417516
PhasePHASE3
Enrollment910
SponsorOntario Clinical Oncology Group (OCOG)
Age50 Years – 120 Years
SexFEMALE
About this study
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.
Interventions
- Radiation: Whole Breast Irradiation (WBI) — The dose fractionation and prescription is 26Gy in 5 fractions to the PTV once per day over 5-7 days (due to holiday weekends up to 8 days will be acceptable).
- Radiation: Partial Breast Irradiation (PBI) — The dose fractionation and prescription is 26Gy in 5 fractions to the PTV prescribed at the isocentre of the treatment fields treated once per day over 5-7 days (due to holiday weekends up to 8 days will be acceptable).
Primary outcomes
- Local Recurrence (Annually for 5 years post-randomization)
- Patient Assessment Cosmesis at 3 years (3 and 5 years post-randomization)
Eligibility information
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.
Study locations
- GenesisCare Darlinghurst, Darlinghurst, New South Wales 2010 Australia
- GenesisCare Hurstville, Hurstville, New South Wales 2220 Australia
- GenesisCare Mater Hospital, North Sydney, New South Wales 2060 Australia
- GenesisCare Bundaberg, Bundaberg, Queensland 4670 Australia
- GenesisCare Southport, Southport, Queensland 4215 Australia
- GenesisCare Tugun, Tugun, Queensland 4224 Australia
- GenesisCare Hervey Bay, Urraween, Queensland 4655 Australia
- GenesisCare St Andrew's, Adelaide, South Australia 5000 Australia
- GenesisCare Bedford Park, Bedford Park, South Australia 5042 Australia
- GenesisCare Wembley, Wembley, Washington 6014 Australia
Showing 10 of 31 reported sites. See the official listing for all locations.
Before you participate: Varda Clinical is an independent discovery tool, not the study sponsor or a medical provider. Eligibility can only be determined by the official study team. Discuss potential risks and benefits with a qualified healthcare professional.
Source: ClinicalTrials.gov. Record last refreshed by Varda Clinical: 2026-10-15.