Actively Recruiting
Radiation OmisSion in PAtients With CLinically Node Negative Breast Cancer Undergoing Lumpectomy
Led by Ontario Clinical Oncology Group (OCOG) · Updated on 2025-11-18
352
Participants Needed
12
Research Sites
394 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
To de-escalate radiation therapy in women with breast cancer.
CONDITIONS
Official Title
Radiation OmisSion in PAtients With CLinically Node Negative Breast Cancer Undergoing Lumpectomy
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Female patient with a new histological diagnosis of clinical T1-3 N0 breast cancer (any tumour sub-type).
- Negative lymph node involvement at initial presentation, documented by imaging (US or MRI), fine needle aspiration (FNA) or core needle biopsy.
- Treated with a minimum of 8 weeks neoadjuvant chemotherapy, with patients with Her2+ disease receiving targeted anti-Her2+ therapy.
- Marker clip placed in the tumour bed prior to or during neoadjuvant chemotherapy when the tumour can still be identified.
- Treated by breast conserving surgery with complete excision of the tumour bed and axillary staging surgery (either sentinel lymph node biopsy or axillary lymph node dissection).
- Final pathology demonstrating a pathological complete response defined as absence of residual invasive and in-situ breast cancer within the breast or lymph nodes (ypT0N0).
You will not qualify if you...
- Age less than 50 years.
- Inflammatory breast cancer or breast cancer invading the skin or chest wall (T4 disease).
- Multicentric disease involving more than one quadrant in the same breast.
- Prior history of ipsilateral or contralateral in-situ or invasive breast cancer. Patients with a history of lobular carcinoma in-situ (LCIS) are ineligible.
- Synchronous contralateral in-situ or invasive breast cancer.
- BRCA 1 or 2 genetic mutation carrier or other genetic mutation associated with increased risk of breast cancer.
- 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 or more years.
- Inability to complete entire course of neoadjuvant therapy (minimum of 8 weeks).
- Patients with HR+ disease who are not planned to have endocrine therapy initiated.
- Patients with Her2+ disease who have not received or are not planned to receive Her2 targeted therapy.
- Eastern Cooperative Oncology Group (ECOG) performance status greater than 3.
- Inability to provide informed consent.
AI-Screening
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Trial Site Locations
Total: 12 locations
1
BC Cancer - Centre for the North
Prince George, British Columbia, Canada, V2M 7E9
Actively Recruiting
2
Royal Victoria Regional Health Centre
Barrie, Ontario, Canada, L4M 6M2
Actively Recruiting
3
Juravinski Cancer Centre
Hamilton, Ontario, Canada, L8V 5C2
Actively Recruiting
4
Cancer Centre of Southeastern Ontario at Kingston
Kingston, Ontario, Canada, K7L 5P9
Actively Recruiting
5
Thunder Bay Regional Health Sciences Centre
Thunder Bay, Ontario, Canada, P7B 6V4
Actively Recruiting
6
Sunnybrook Health Sciences -Odette Cancer Centre
Toronto, Ontario, Canada, M4N 3M5
Actively Recruiting
7
CHUM - Centre Hospitalier de L'Université de Montréal
Montreal, Quebec, Canada, H2L 4M1
Actively Recruiting
8
Jewish General Hospital
Montreal, Quebec, Canada, H3T 1E2
Actively Recruiting
9
CHU de Quebec - Universite Laval
Québec, Quebec, Canada, G1R 2J6
Actively Recruiting
10
Centre hospitalier de Lanaudière
Saint-Charles-Borromée, Quebec, Canada, J6E 6J2
Actively Recruiting
11
Centre Hospitalier Trois Rivieres Ste-Marie
Trois-Rivières, Quebec, Canada, G8Z 3R9
Actively Recruiting
12
McGill University Health Centre (MUHC)
Montreal, Q, Canada, H4A 3J1
Actively Recruiting
Research Team
A
Adrianne Van Dam
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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