RECRUITING Phase 3 ClinicalTrials.gov

A Randomized Trial of Five Fraction Partial Breast Irradiation (RAPID2)

Sponsor: Ontario Clinical Oncology Group (OCOG) • ClinicalTrials.gov ID: NCT05417516

Registry updated: 2026-09-14

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Description

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

Whole Breast Irradiation (WBI) (Radiation)
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).
Partial Breast Irradiation (PBI) (Radiation)
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).

Eligibility criteria

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.

Conditions

Breast Neoplasm Female Radiotherapy Cosmetic Outcome

Locations

GenesisCare Darlinghurst — Darlinghurst, New South Wales, Australia
GenesisCare Hurstville — Hurstville, New South Wales, Australia
GenesisCare Mater Hospital — North Sydney, New South Wales, Australia
GenesisCare Bundaberg — Bundaberg, Queensland, Australia
GenesisCare Southport — Southport, Queensland, Australia
GenesisCare Tugun — Tugun, Queensland, Australia
GenesisCare Hervey Bay — Urraween, Queensland, Australia
GenesisCare St Andrew's — Adelaide, South Australia, Australia
GenesisCare Bedford Park — Bedford Park, South Australia, Australia
GenesisCare Wembley — Wembley, Washington, Australia
GenesisCare Fiona Stanley Hospital — Murdoch, Western Austrailia, Australia
GenesisCare Hollywood — Nedlands, Western Australia, Australia
Arthur J. E. Child Comprehensive Cancer Centre-Clinical Research Unit — Calgary, Alberta, Canada
BC Cancer - Vancouver Island Centre — Victoria, British Columbia, Canada
BCCA-Vancouver Island Cancer Centre — Victoria, British Columbia, Canada
QEII HSC - Nova Scotia Cancer Centre — Halifax, Nova Scotia, Canada
Royal Victoria Regional Health Centre — Barrie, Ontario, Canada
Juravinski Cancer Centre — Hamilton, Ontario, Canada
London Regional Cancer Centre — London, Ontario, Canada
Stronach (Southlake) Regional Health Centre — Newmarket, Ontario, Canada
Algoma District Cancer Program — Sault Ste. Marie, Ontario, Canada
Princess Margaret Hospital — Toronto, Ontario, Canada
Toronto-Sunnybrook Health Sciences Centre - Odette Cancer Centre — Toronto, Ontario, Canada
Windsor Regional Cancer Centre — Windsor, Ontario, Canada
CSSS Champlain - Charles LeMoyne — Greenfield Park, Quebec, Canada
CHUM - Centre Hospitalier de L'Université de Montréal — Montreal, Quebec, Canada
McGill University Health Centre — Montreal, Quebec, Canada
CHUQ-Pavillon Hotel-Dieu de Quebec — Québec, Quebec, Canada
CHUS-Hopital Fleurimont — Sherbrooke, Quebec, Canada
Centre Intégré Universitaire de Santé et de Services Sociaux de la Mauricie-Centre-du-Québec (CIUSSS MCQ) — Trois-Rivières, Quebec, Canada
Saskatoon Cancer Centre — Saskatoon, Saskatchewan, Canada

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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

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