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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT05866458
Registration number
NCT05866458
Ethics application status
Date submitted
10/05/2023
Date registered
19/05/2023
Date last updated
8/08/2025
Titles & IDs
Public title
Radiation OmisSion in PAtients With CLinically Node Negative Breast Cancer Undergoing Lumpectomy
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Scientific title
Radiation OmisSion in PAtients With CLinically Node Negative Breast Cancer Undergoing Lumpectomy and With a PathologIc Complete REsponse After Neoadjuvant Chemotherapy
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Secondary ID [1]
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OCOG-2022-ROSALIE
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Universal Trial Number (UTN)
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Trial acronym
ROSALIE
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Breast Cancer
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Condition category
Condition code
Cancer
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Breast
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Intervention/exposure
Study type
Observational
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Patient registry
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Target follow-up duration
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Target follow-up type
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Description of intervention(s) / exposure
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).
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Ipsilateral breast tumour recurrence (IBTR)
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Assessment method [1]
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defined as ipsilateral recurrence (invasive or insitu) in the ipsilateral breast or chest wall. Histological evidence of IBTR is required. All such events will be reviewed by a central adjudication committee.
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Timepoint [1]
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5 years
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Secondary outcome [1]
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Mastectomy free interval
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Assessment method [1]
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defined as time from registration to undergoing ipsilateral mastectomy.
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Timepoint [1]
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5 years
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Secondary outcome [2]
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Relapse free interval (RFI)
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Assessment method [2]
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defined as time from registration to recurrence of invasive disease in the ipsilateral breast, regional nodes (axilla, supraclavicular, or internal mammary), distant areas beyond local or regional limits (distant recurrence), and death from breast cancer.
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Timepoint [2]
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5 years
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Secondary outcome [3]
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Disease free survival (DFS)
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Assessment method [3]
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defined as time from registration to in breast invasive tumour recurrence, regional invasive recurrence, distant recurrence, contralateral breast cancer, second primary non-breast cancers, death from breast cancer, and death from non-breast cancer.
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Timepoint [3]
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5 years
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Secondary outcome [4]
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Overall survival (OS)
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Assessment method [4]
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defined as time from registration to death from any cause.
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Timepoint [4]
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5 years
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Eligibility
Key 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)].
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Minimum age
50
Years
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Maximum age
No limit
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Sex
Females
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Can healthy volunteers participate?
No
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Key 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.
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Study design
Purpose
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Duration
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Selection
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Timing
Prospective
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Statistical methods / analysis
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Recruitment
Recruitment status
Recruiting
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
12/03/2024
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
1/10/2031
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Actual
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Sample size
Target
352
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
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Recruitment outside Australia
Country [1]
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Canada
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State/province [1]
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Ontario
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Country [2]
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Canada
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State/province [2]
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Quebec
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Funding & Sponsors
Primary sponsor type
Other
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Name
Ontario Clinical Oncology Group (OCOG)
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Address
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Country
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Ethics approval
Ethics application status
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Summary
Brief summary
To de-escalate radiation therapy in women with breast cancer.
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Trial website
https://clinicaltrials.gov/study/NCT05866458
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Trial related presentations / publications
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Public notes
This record is viewable in the ANZCTR as it had previously listed Australia and/or New Zealand as a recruitment site, however these sites have since been removed
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Contacts
Principal investigator
Name
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Elena Parvez, MD
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Address
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Juravinski Cancer Centre
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Adrianne Van Dam
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Address
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Country
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Phone
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905-527-2299
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Fax
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Email
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[email protected]
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Contact person for scientific queries
Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
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No/undecided IPD sharing reason/comment
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What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results not provided in
https://clinicaltrials.gov/study/NCT05866458
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