Radiation OmisSion in PAtients With CLinically Node Negative Breast Cancer Undergoing Lumpectomy
NCT ID: NCT05866458
Last Updated: 2025-11-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
352 participants
OBSERVATIONAL
2024-03-12
2031-10-31
Brief Summary
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Detailed Description
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The primary outcome is ipsilateral breast tumour recurrence (IBTR) at median 5-year follow-up. Study participants will be followed and assessed for local recurrence, regional recurrence, distant recurrence, DFS and OS. In addition, any additional breast cancer treatments received by the participant for the first recurrence event including repeat BCS, mastectomy, additional systemic therapy and radiation therapy (RT) will be documented. The planned sample size is 352 study participants.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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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).
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
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
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.
50 Years
FEMALE
No
Sponsors
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Ontario Clinical Oncology Group (OCOG)
OTHER
Responsible Party
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Principal Investigators
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Elena Parvez, MD
Role: PRINCIPAL_INVESTIGATOR
Juravinski Cancer Centre
Thierry Muanza, MD
Role: PRINCIPAL_INVESTIGATOR
Jewish General Hospital
Mark Basik, MD
Role: PRINCIPAL_INVESTIGATOR
Jewish General Hospital
Locations
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BC Cancer - Centre for the North
Prince George, British Columbia, Canada
Royal Victoria Regional Health Centre
Barrie, Ontario, Canada
Juravinski Cancer Centre
Hamilton, Ontario, Canada
Cancer Centre of Southeastern Ontario at Kingston
Kingston, Ontario, Canada
Thunder Bay Regional Health Sciences Centre
Thunder Bay, Ontario, Canada
Sunnybrook Health Sciences -Odette Cancer Centre
Toronto, Ontario, Canada
CHUM - Centre Hospitalier de L'Université de Montréal
Montreal, Quebec, Canada
Jewish General Hospital
Montreal, Quebec, Canada
CHU de Quebec - Universite Laval
Québec, Quebec, Canada
Centre hospitalier de Lanaudière
Saint-Charles-Borromée, Quebec, Canada
Centre Hospitalier Trois Rivieres Ste-Marie
Trois-Rivières, Quebec, Canada
McGill University Health Centre (MUHC)
Montreal, Q, Canada
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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OCOG-2022-ROSALIE
Identifier Type: -
Identifier Source: org_study_id
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