NCT05417516 A Randomized Trial of Five Fraction Partial Breast Irradiation (RAPID2)
| NCT ID | NCT05417516 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | Ontario Clinical Oncology Group (OCOG) |
| Condition | Breast Neoplasm Female |
| Study Type | INTERVENTIONAL |
| Enrollment | 910 participants |
| Start Date | 2023-11-20 |
| Primary Completion | 2029-11 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 910 participants in total. It began in 2023-11-20 with a primary completion date of 2029-11.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
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.
Contact & Investigator
Timothy Whelan, M.D.
PRINCIPAL INVESTIGATOR
Juravinski Cancer Centre and McMaster University
Frequently Asked Questions
Who can join the NCT05417516 clinical trial?
This trial is open to female participants only, aged 50 Years or older, up to 120 Years, studying Breast Neoplasm Female. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05417516 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 910 participants.
Is NCT05417516 currently recruiting?
Yes, NCT05417516 is actively recruiting participants. Contact the research team at schamber@mcmaster.ca for enrollment information.
Where is the NCT05417516 trial being conducted?
This trial is being conducted at Darlinghurst, Australia, Hurstville, Australia, North Sydney, Australia, Bundaberg, Australia and 11 additional locations.
Who is sponsoring the NCT05417516 clinical trial?
NCT05417516 is sponsored by Ontario Clinical Oncology Group (OCOG). The principal investigator is Timothy Whelan, M.D. at Juravinski Cancer Centre and McMaster University. The trial plans to enroll 910 participants.