Recruiting

Radiation OmisSion

Sponsor:

Ontario Clinical Oncology Group (OCOG)

Code:

NCT05866458

Conditions

Breast Cancer

Eligibility Criteria

Sex: Female

Age: 50+

Healthy Volunteers: Not accepted

Study Details

Brief summary:

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

Conditions

Breast Cancer

Study ID

NCT05866458

Start date

Mar 12, 2024

Status verified date

Sep, 2025

Completion date

Oct, 2031

Anticipated

Primary completion date

Oct, 2031

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 50+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

352 participants

Anticipated

Interventions and Outcome Measures

Arms

Single Arm Cohort

The study population consists of women with newly diagnosed T1-3 node negative breast cancer with no clinical evidence of distant metastatic disease, that have been treated with NAC, BCS and axillary staging surgery with final pathology demonstrating a pCR (defined as absence of residual invasive and in situ breast cancer within the breast or lymph nodes).

Primary outcome measure

  • Ipsilateral breast tumour recurrence (IBTR) [ Time Frame: 5 years ]

Central Contacts and Locations

Central contacts

Locations

BC Cancer - Centre for the North

Recruiting

Prince George, British Columbia, Canada, V2M 7E9

Contacts

Principal Investigator:

Andre Gouveia, Dr

Royal Victoria Regional Health Centre

Recruiting

Barrie, Ontario, Canada, L4M 6M2

Contacts

Principal Investigator:

Christiaan Stevens, Dr

Juravinski Cancer Centre

Recruiting

Hamilton, Ontario, Canada, L8V 5C2

Contacts

Principal Investigator:

Elena Parvez, Dr.

Cancer Centre of Southeastern Ontario at Kingston

Recruiting

Kingston, Ontario, Canada, K7L 5P9

Contacts

Principal Investigator:

Timothy E Owen, Dr

Thunder Bay Regional Health Sciences Centre

Recruiting

Thunder Bay, Ontario, Canada, P7B 6V4

Contacts

Principal Investigator:

Margaret Anthes, Dr

Sunnybrook Health Sciences -Odette Cancer Centre

Recruiting

Toronto, Ontario, Canada, M4N 3M5

Contacts

Principal Investigator:

Irene Karam, Dr

CHUM - Centre Hospitalier de L'Université de Montréal

Recruiting

Montreal, Quebec, Canada, H2L 4M1

Contacts

Principal Investigator:

Jean-Marc Bourque, Dr

Jewish General Hospital

Recruiting

Montreal, Quebec, Canada, H3T 1E2

Contacts

Principal Investigator:

Thierry Muanza, Dr

CHU de Quebec - Universite Laval

Recruiting

Québec, Quebec, Canada, G1R 2J6

Contacts

Principal Investigator:

Valerie Theberge, Dr

Centre hospitalier de Lanaudière

Recruiting

Saint-Charles-Borromée, Quebec, Canada, J6E 6J2

Contacts

Principal Investigator:

Dominique Morency, Dr

Centre Hospitalier Trois Rivieres Ste-Marie

Recruiting

Trois-Rivières, Quebec, Canada, G8Z 3R9

Contacts

Principal Investigator:

Rafika Dahmane, Dr

McGill University Health Centre (MUHC)

Recruiting

Montreal, Q, Canada, H4A 3J1

Contacts

Principal Investigator:

Christine Lambert, Dr

More Information

Sponsor

Ontario Clinical Oncology Group (OCOG)

Last update posted

Aug 28, 2026

Last verified

Sep, 2025

Keywords

  • Clinically node negative breast cancer
  • Ipsilateral breast tumour recurrence
  • Neoadjuvant chemotherapy

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Ontario Clinical Oncology Group (OCOG) on 2026-08-28.