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Clinical Trials in Canada / NCT05866458
Recruiting Observational

Radiation OmisSion in PAtients With CLinically Node Negative Breast Cancer Undergoing Lumpectomy

NCT05866458 · tracked via the Priya Life Science Canada tracker
Phase
Observational
Started
2024-03-12
Last updated
2026-08-28

Condition(s) studied

Breast Cancer

Study summary

To de-escalate radiation therapy in women with breast cancer.

Eligibility

Sex
FEMALE
Min age
50 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: 1. Female patient with a new histological diagnosis of clinical T1-3 N0 breast cancer (any tumour sub-type). 2. Negative lymph node involvement at initial presentation, documented by imaging (US or MRI), fine needle aspiration (FNA) or core needle biopsy. 3. Treated with a minimum of 8 weeks NAC, with patients with Her2+ disease receiving targeted anti-Her2+ therapy. 4. Marker clip placed in the tumour bed prior to or during neoadjuvant chemotherapy when the tumour can still be identified. 5. Treated by BCS with complete excision of the tumour bed and axillary staging surgery (either sentinel lymph node biopsy or axillary lymph node dissection). 6. Final pathology demonstrating a pCR \[defined as absence of residual invasive and in-situ breast cancer within the breast or lymph nodes (ypT0N0)\]. Exclusion Criteria: 1. Age less than 50 years. 2. Inflammatory breast cancer or breast cancer invading the skin or chest wall (T4 disease). 3. Multicentric disease (i.e., breast cancer involving more than one quadrant in the same breast). 4. Prior history of ipsilateral or contralateral in-situ or invasive breast cancer. Patients with a history of lobular carcinoma in-situ (LCIS) are ineligible. 5. Synchronous contralateral in-situ or invasive breast cancer. 6. BRCA (breast cancer gene) 1 or 2 genetic mutation carrier, or other genetic mutation present associated with increased risk of breast cancer. 7. Other previous non-breast malignancies except adequately treated non-melanoma skin cancers, in situ cancers or other cancers curatively treated with no evidence of disease for ≥ 5 years. 8. Inability to complete entire course of neoadjuvant therapy (minimum of 8 weeks of treatment). 9. Patients with HR+ (hormone receptor) disease who are not planned to have endocrine therapy initiated. 10. Patients with Her2+ disease who have not received or are not planned to receive Her2 targeted therapy. 11. ECOG (Eastern Cooperative Oncology Group) performance status \> 3. 12. Inability to provide informed consent.

Primary outcome measure(s)

Trial sites (27)

FacilityCityRegionStatus
Tweed Valley Hospital Cudgen Cudgen Recruiting
Liverpool Hospital Liverpool New South Wales Recruiting
Mater Hospital Sydney North Sydney New South Wales Recruiting
Westmead Hospital Westmead New South Wales Recruiting
Royal Brisbane and Women's Hospital Herston Queensland Recruiting
Princess Alexandra Hospital Woolloongabba Queensland Recruiting
Monash Medical Centre -Moorabbin Bentleigh East Victoria Recruiting
Victorian Breast & Oncology Care (VBOC) East Melbourne Victoria Recruiting
Peter MacCallum Cancer Centre Melbourne Victoria Recruiting
St. Vincent's Hospital Melbourne Melbourne Victoria Recruiting
Sir Charles Gairdner Hospital Nedlands Western Australia Recruiting
Maroondah Hospital Box Hill Australia Recruiting
Royal Perth Hospital Perth Australia Recruiting
Prince of Wales Hospital Randwick Australia Recruiting
Latrobe Regional Health Traralgon Australia Recruiting
BC Cancer - Centre for the North Prince George British Columbia Recruiting
Royal Victoria Regional Health Centre Barrie Ontario Recruiting
Juravinski Cancer Centre Hamilton Ontario Recruiting
Cancer Centre of Southeastern Ontario at Kingston Kingston Ontario Recruiting
Thunder Bay Regional Health Sciences Centre Thunder Bay Ontario Recruiting
Sunnybrook Health Sciences -Odette Cancer Centre Toronto Ontario Recruiting
CHUM - Centre Hospitalier de L'Université de Montréal Montreal Quebec Recruiting
Jewish General Hospital Montreal Quebec Recruiting
CHU de Quebec - Universite Laval Québec Quebec Recruiting
Centre hospitalier de Lanaudière Saint-Charles-Borromée Quebec Recruiting
Centre Hospitalier Trois Rivieres Ste-Marie Trois-Rivières Quebec Recruiting
McGill University Health Centre (MUHC) Montreal Q Recruiting

More Ontario Clinical Oncology Group (OCOG) trials in Canada

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05866458 on ClinicalTrials.gov ↗ ← All trials in Canada