Radiation OmisSion in PAtients With CLinically Node Negative Breast Cancer Undergoing Lumpectomy (ROSALIE)

August 26, 2026 updated by: Ontario Clinical Oncology Group (OCOG)

Radiation OmisSion in PAtients With CLinically Node Negative Breast Cancer Undergoing Lumpectomy and With a PathologIc Complete REsponse After Neoadjuvant Chemotherapy

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

Study Overview

Status

Recruiting

Conditions

Detailed Description

The study is a prospective, multi-center, single arm cohort study of omission of adjuvant whole breast radiation therapy (WBRT) following breast conserving surgery (BCS) in patients with a pathological complete response (pCR) following neoadjuvant chemotherapy (NAC). Eligible and consenting female patients with newly diagnosed T1-3 node negative breast cancer with no clinical evidence of distant metastatic disease, who have been treated with NAC, BCS and axillary staging surgery with final pathology demonstrating a pCR (ypT0N0) will be enrolled to the study and followed. The first analysis is planned when follow-up is a median of 5 years. Study participants will not receive adjuvant WBRT, the current standard of care.

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.

Study Type

Observational

Enrollment (Estimated)

352

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Australia
      • Box Hill, Australia, 3128
      • Perth, Australia, 6000
        • Recruiting
        • Royal Perth Hospital
        • Contact:
        • Principal Investigator:
          • Samantha Chen, Dr
      • Randwick, Australia, 2031
        • Recruiting
        • Prince of Wales Hospital
        • Contact:
        • Principal Investigator:
          • Boon Chua, Dr
      • Traralgon, Australia, 3844
    • Cudgen
      • Cudgen, Cudgen, Australia, 2487
    • New South Wales
    • Queensland
    • Victoria
      • Bentleigh East, Victoria, Australia, 3165
        • Recruiting
        • Monash Medical Centre -Moorabbin
        • Contact:
        • Contact:
        • Principal Investigator:
          • Corinne Ooi, Dr
      • East Melbourne, Victoria, Australia, 3002
        • Recruiting
        • Victorian Breast & Oncology Care (VBOC)
        • Contact:
        • Contact:
        • Principal Investigator:
          • Jocelyn Lippey, Dr
      • Melbourne, Victoria, Australia, 3000
      • Melbourne, Victoria, Australia, 3065
        • Recruiting
        • St. Vincent's Hospital Melbourne
        • Principal Investigator:
          • Jocelyn Lippey, Dr
        • Contact:
        • Contact:
    • Western Australia
  • Canada
    • British Columbia
      • Prince George, British Columbia, Canada, V2M 7E9
        • Recruiting
        • BC Cancer - Centre for the North
        • Contact:
        • Principal Investigator:
          • Andre Gouveia, Dr
    • Ontario
      • Barrie, Ontario, Canada, L4M 6M2
        • Recruiting
        • Royal Victoria Regional Health Centre
        • Contact:
        • Principal Investigator:
          • Christiaan Stevens, Dr
      • Hamilton, Ontario, Canada, L8V 5C2
        • Recruiting
        • Juravinski Cancer Centre
        • Contact:
        • Principal Investigator:
          • Elena Parvez, Dr.
      • Kingston, Ontario, Canada, K7L 5P9
        • Recruiting
        • Cancer Centre of Southeastern Ontario at Kingston
        • Contact:
        • Principal Investigator:
          • Timothy E Owen, Dr
      • Thunder Bay, Ontario, Canada, P7B 6V4
        • Recruiting
        • Thunder Bay Regional Health Sciences Centre
        • Contact:
        • Contact:
        • Principal Investigator:
          • Margaret Anthes, Dr
      • Toronto, Ontario, Canada, M4N 3M5
        • Recruiting
        • Sunnybrook Health Sciences -Odette Cancer Centre
        • Contact:
        • Principal Investigator:
          • Irene Karam, Dr
    • Q
      • Montreal, Q, Canada, H4A 3J1
        • Recruiting
        • McGill University Health Centre (MUHC)
        • Contact:
        • Principal Investigator:
          • Christine Lambert, Dr
    • Quebec
      • Montreal, Quebec, Canada, H3T 1E2
        • Recruiting
        • Jewish General Hospital
        • Contact:
        • Principal Investigator:
          • Thierry Muanza, Dr
        • Sub-Investigator:
          • Mark Basik, Dr
      • Montreal, Quebec, Canada, H2L 4M1
        • Recruiting
        • CHUM - Centre Hospitalier de l'Université de Montréal
        • Contact:
        • Principal Investigator:
          • Jean-Marc Bourque, Dr
      • Québec, Quebec, Canada, G1R 2J6
        • Recruiting
        • CHU de Québec - Université Laval
        • Contact:
        • Principal Investigator:
          • Valerie Theberge, Dr
      • Saint-Charles-Borromée, Quebec, Canada, J6E 6J2
      • Trois-Rivières, Quebec, Canada, G8Z 3R9

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Written informed consent will be obtained from all eligible patients who agree to participate. Until the patient has been completely informed of the study, has freely consented to take part in the study and has signed and dated an informed consent form that has received documented approval by an authorized Research Ethics Board (REB), no study related assessments, including those required for screening can be performed.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Ipsilateral breast tumour recurrence (IBTR)
Time Frame: 5 years
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.
5 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mastectomy free interval
Time Frame: 5 years
defined as time from registration to undergoing ipsilateral mastectomy.
5 years
Relapse free interval (RFI)
Time Frame: 5 years
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.
5 years
Disease free survival (DFS)
Time Frame: 5 years
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.
5 years
Overall survival (OS)
Time Frame: 5 years
defined as time from registration to death from any cause.
5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ontario Clinical Oncology Group (OCOG)

Collaborators

Canadian Institutes of Health Research (CIHR)
Hamilton Health Sciences Corporation

Investigators

  • Principal Investigator: Elena Parvez, MD, Juravinski Cancer Centre
  • Principal Investigator: Thierry Muanza, MD, Jewish General Hospital
  • Principal Investigator: Mark Basik, MD, Jewish General Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 12, 2024

Primary Completion (Estimated)

October 1, 2031

Study Completion (Estimated)

October 1, 2031

Study Registration Dates

First Submitted

May 10, 2023

First Submitted That Met QC Criteria

May 10, 2023

First Posted (Actual)

May 19, 2023

Study Record Updates

Last Update Posted (Actual)

August 28, 2026

Last Update Submitted That Met QC Criteria

August 26, 2026

Last Verified

September 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • OCOG-2022-ROSALIE

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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