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

What this study is about

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.

Who can join (things the study team will check)

✅ You may be able to join if…

• 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 be able to join if…

• 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 this trial is running

• 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

+ 18 more sites.

Who to contact

Shelley Chambers, MA · 905-527-2299 · schamber@mcmaster.ca

It's completely normal to call and ask questions before deciding anything. Mention the study ID: NCT05417516.