Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12625001038482p
Ethics application status
Not yet submitted
Date submitted
20/08/2025
Date registered
19/09/2025
Date last updated
19/09/2025
Date data sharing statement initially provided
19/09/2025
Type of registration
Prospectively registered

Titles & IDs
Public title
Radiation OmisSion in PAtients With CLinically Node Negative Breast Cancer Undergoing Lumpectomy (2501/OCOG-2022 ROSALIE) substudy: Assessing the impact of treatment on patient quality of life for adults recruited from Australia and New Zealand
Scientific title
Radiation OmisSion in PAtients With CLinically Node Negative Breast Cancer Undergoing Lumpectomy (2501/OCOG-2022 ROSALIE) substudy: Assessing the impact of treatment on patient quality of life for adults recruited from Australia and New Zealand
Secondary ID [1] 315188 0
BCT 2501/OCOG-2022
Universal Trial Number (UTN)
Trial acronym
ROSALIE-PRO
Linked study record
NCT05866458 (This record is a substudy of this study. The substudy is being run in Australia and New Zealand only).

Health condition
Health condition(s) or problem(s) studied:
Breast Cancer 338632 0
Condition category
Condition code
Cancer 334924 334924 0 0
Breast

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
This substudy will assess the impact of RT omission on patient experience and outcomes including quality of life (QOL), fear of cancer recurrence, distress, decisional conflict, and decisional regret. These are of known importance to patients and relevance to patient-centred treatment decision-making.

Data will be collected from a range of questionnaires administered at Baseline, and then 6 months, 12 months, 3 years and 5 years after Registration.

PROMs will be administered via an online platform. Participants will receive an email reminder from the system when each assessment is due. The email will contain a link to the appropriate assessment which will be accessed and completed by the participant online. Printable PROMs will be available in the event of technology problems or where online questionnaires are not permitted. It will take a maximum of 20 minutes to complete all of the questionnaires.
Intervention code [1] 331805 0
Not applicable
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 342556 0
The impact of radiation therapy omission on patient experience and outcomes.
Timepoint [1] 342556 0
Measured at Baseline, 6 months, 12 months, 3 years and 5 years after Registration
Primary outcome [2] 342557 0
The impact of radiation therapy omission on patient quality of life.
Timepoint [2] 342557 0
Measured at Baseline, and then 6 months, 12 months, 3 years and 5 years after Registration.
Primary outcome [3] 342558 0
The impact of radiation therapy omission on patient fear of cancer recurrence.
Timepoint [3] 342558 0
Measured at Baseline, and then 6 months, 12 months, 3 years and 5 years after Registration.
Secondary outcome [1] 451290 0
Impact of radiation therapy omission on patient decisional conflict (primary outcome)
Timepoint [1] 451290 0
Measured at Baseline.
Secondary outcome [2] 451291 0
Impact of radiation therapy omission on patient decisional regret (primary outcome).
Timepoint [2] 451291 0
Measured at 6 months, 12 months, 3 years and 5 years after Registration.
Secondary outcome [3] 452055 0
Impact of radiation therapy omission on patient distress (primary outcome)
Timepoint [3] 452055 0
Measured at Baseline, and at 6 months, 12 months, 3 years and 5 years after Registration.

Eligibility
Key inclusion criteria
ROSALIE study Inclusion Criteria:
1. Female patient with a new histological diagnosis of clinical T1-3 N0 breast cancer (any tumour sub-type). (see AJCC TNM Cancer Staging, Appendix I).
2. Negative lymph node involvement at initial presentation, documented by imaging (US or MRI), 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)].

ROSALIE-PRO substudy:
1) Participants must meet all entry criteria for the BCT 2501/OCOG-2022 ROSALIE study. Data for the PRO substudy will be collected from all registered participants who consent to the PRO substudy.
2) Participants must have given informed consent using the BCT 2501/OCOG-2022 ROSALIE study PICF, which contains information about the PRO substudy. The consent must be signed and dated by the participant and investigator.
3) Participants are able (i.e. sufficiently fluent) and willing to complete the Patient Reported Outcome Measures in English.
Minimum age
50 Years
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion criteria for the ROSALIE-PRO substudy as per the main ROSALIE study (NCT05866458):
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 LCIS are ineligible.
5. Synchronous contralateral in-situ or invasive breast cancer.
6. BRCA 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+ 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 performance status > 3.
12. Inability to provide informed consent.

Study design
Purpose
Psychosocial
Duration
Longitudinal
Selection
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
15/12/2025
Actual
Date of last participant enrolment
Anticipated
15/12/2029
Actual
Date of last data collection
Anticipated
15/12/2034
Actual
Sample size
Target
59
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,TAS,WA,VIC
Recruitment outside Australia
Country [1] 27308 0
New Zealand
State/province [1] 27308 0

Funding & Sponsors
Funding source category [1] 319759 0
Other Collaborative groups
Name [1] 319759 0
Breast Cancer Trials
Country [1] 319759 0
Australia
Primary sponsor type
Other Collaborative groups
Name
Breast Cancer Trials
Address
Country
Australia
Secondary sponsor category [1] 322265 0
Other Collaborative groups
Name [1] 322265 0
Ontario Clinical Oncology Group
Address [1] 322265 0
Country [1] 322265 0
Canada

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 318314 0
Hunter New England Human Research Ethics Committee
Ethics committee address [1] 318314 0
Ethics committee country [1] 318314 0
Australia
Date submitted for ethics approval [1] 318314 0
31/10/2025
Approval date [1] 318314 0
Ethics approval number [1] 318314 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 143786 0
Prof Boon Chua
Address 143786 0
Director of Cancer & Haematology Services, Prince of Wales Hospital, High Street, Randwick NSW 2031
Country 143786 0
Australia
Phone 143786 0
+61 2 4925 5235
Fax 143786 0
Email 143786 0
[email protected]
Contact person for public queries
Name 143787 0
Corinna Beckmore
Address 143787 0
Breast Cancer Trials PO Box 283 The Junction NSW 2291
Country 143787 0
Australia
Phone 143787 0
+61 2 4925 5235
Fax 143787 0
Email 143787 0
[email protected]
Contact person for scientific queries
Name 143788 0
Prof Boon Chua
Address 143788 0
Director of Cancer & Haematology Services, Prince of Wales Hospital, Randwick NSW 2031
Country 143788 0
Australia
Phone 143788 0
+61 2 4925 5235
Fax 143788 0
Email 143788 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
No
No IPD sharing reason/comment: OCOG have indicated that they will not be sharing individual participant data.



What supporting documents are/will be available?

No Supporting Document Provided


Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.