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Study identifier: NCT05417516 Synced from ClinicalTrials.gov · August 07, 2026
● Study status: Recruiting

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

Condition: Breast Neoplasm Female · Radiotherapy · Cosmetic Outcome  ·  Sponsor: Ontario Clinical Oncology Group (OCOG)

PhasePhase 3
Planned participants910
Who can joinFemale, 50 Years to 120 Years
Healthy volunteersNoCheck eligibility criteria ↓
Where30 locations · 2 countries

Interested? Contact the study team ↓

Sponsor, CRO or site team? See where this study is running → — listed sites, countries and recruiting context. Everything below is written for patients and caregivers.

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.

This description comes directly from the study's public registry record.

Talk to the study team

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

Erin McGean  ·  905-527-2299  ·  mcgeane@mcmaster.ca

There is no obligation to join — the study team can answer your questions about taking part.

Always discuss trial participation with your own doctor first.

Full eligibility criteria (exactly as the study team wrote them)

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.

Reproduced word-for-word from the public registry record — the study team can answer questions about it.

Locations (30)

GenesisCare DarlinghurstDarlinghurst, New South Wales, AustraliaRecruiting
GenesisCare HurstvilleHurstville, New South Wales, AustraliaRecruiting
GenesisCare Mater HospitalNorth Sydney, New South Wales, AustraliaRecruiting
GenesisCare BundabergBundaberg, Queensland, AustraliaRecruiting
GenesisCare SouthportSouthport, Queensland, AustraliaRecruiting
GenesisCare TugunTugun, Queensland, AustraliaRecruiting
GenesisCare Hervey BayUrraween, Queensland, AustraliaRecruiting
GenesisCare St Andrew'sAdelaide, South Australia, AustraliaRecruiting
GenesisCare Bedford ParkBedford Park, South Australia, AustraliaRecruiting
GenesisCare WembleyWembley, Washington, AustraliaRecruiting
GenesisCare Fiona Stanley HospitalMurdoch, Western Austrailia, AustraliaRecruiting
GenesisCare HollywoodNedlands, Western Australia, AustraliaRecruiting

+ 18 more locations — full list on the registry record.

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