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

Recruiting now · Phase 3

Conditions studied: Breast Neoplasm Female, Radiotherapy, Cosmetic Outcome

In brief

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.

Key facts

Study ID

NCT05417516

Run by

Ontario Clinical Oncology Group (OCOG)

People needed

910

Starts

2023-11-20

Expected to finish

2031-11-01

Last updated by the study team

2026-07-07

Who can join

Age: 50 and older, up to 120. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• For inclusion in this study, patients must fulfill all of the following criteria:
• 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).
• Treated by BCS with microscopically clear resection margins >= 1mm for invasive and non-invasive disease or no residual disease on re-excision.
• 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

You may not qualify if…

• Patients who satisfy any of the following exclusion criteria are NOT eligible for this study:
• Age less than 50 years.
• Known to be BRCA 1 and/or BRCA 2 positive.
• Tumour size >3cm in greatest diameter on pathological examination.
• 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
• Evidence of a DCIS component > 3cm
• Lobular carcinoma only.
• More than one primary tumour in different quadrants of the same breast (patients with multifocal breast cancer are eligible).
• Synchronous or previous contralateral breast cancer (patients with contralateral DCIS or LCIS are eligible).
• History of non-breast malignancy within the last 5 years other than treated non-melanoma skin cancer or treated in-situ carcinoma.
• Known pregnancy or currently lactating.
• Inability to localize tumour bed on CT planning (no evidence of surgical clips or seroma).
• Inability to plan the patient for the experimental technique.

Where it is running

• Saskatoon Cancer Centre — Saskatoon, Saskatchewan, Canada (enrolling)
• GenesisCare Hurstville — Hurstville, New South Wales, Australia (enrolling)
• GenesisCare Mater Hospital — North Sydney, New South Wales, Australia (enrolling)
• GenesisCare Bundaberg — Bundaberg, Queensland, Australia (enrolling)
• GenesisCare Southport — Southport, Queensland, Australia (enrolling)
• GenesisCare Tugun — Tugun, Queensland, Australia (enrolling)
• GenesisCare Hervey Bay — Urraween, Queensland, Australia (enrolling)
• GenesisCare St Andrew's — Adelaide, South Australia, Australia (enrolling)
• GenesisCare Bedford Park — Bedford Park, South Australia, Australia (enrolling)
• GenesisCare Wembley — Wembley, Washington, Australia (enrolling)
• GenesisCare Fiona Stanley Hospital — Murdoch, Western Austrailia, Australia (enrolling)
• GenesisCare Hollywood — Nedlands, Western Australia, Australia (enrolling)
• Arthur J. E. Child Comprehensive Cancer Centre-Clinical Research Unit — Calgary, Alberta, Canada (enrolling)
• GenesisCare Darlinghurst — Darlinghurst, New South Wales, Australia (enrolling)
• QEII HSC - Nova Scotia Cancer Centre — Halifax, Nova Scotia, Canada (enrolling)
• Royal Victoria Regional Health Centre — Barrie, Ontario, Canada (enrolling)
• Juravinski Cancer Centre — Hamilton, Ontario, Canada (enrolling)
• London Regional Cancer Centre — London, Ontario, Canada (enrolling)
• Stronach (Southlake) Regional Health Centre — Newmarket, Ontario, Canada (enrolling)
• Algoma District Cancer Program — Sault Ste. Marie, Ontario, Canada (enrolling)
• Princess Margaret Hospital — Toronto, Ontario, Canada (enrolling)
• Toronto-Sunnybrook Health Sciences Centre - Odette Cancer Centre — Toronto, Ontario, Canada (enrolling)
• Windsor Regional Cancer Centre — Windsor, Ontario, Canada (enrolling)
• CSSS Champlain - Charles LeMoyne — Greenfield Park, Quebec, Canada (enrolling)
• CHUM - Centre Hospitalier de L'Université de Montréal — Montreal, Quebec, Canada (enrolling)

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.