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

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: Breast Cancer

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

• Study Contact: Name: Sharon Nason; Phone Number: 42622 905-527-2299; Email: nasons@mcmaster.ca
• Study Contact Backup: Name: Adrianne Van Dam; Phone Number: 42607 905-527-2299; Email: avandam@mcmaster.ca

Study Locations

• Canada
  • Ontario
    • Hamilton, Ontario, Canada, L8V 5C2
      • Recruiting
      • Juravinski Cancer Centre
      • Contact: Meaghan Preston; Phone Number: 47106 905-521-2100; Email: prestm1@mcmaster.ca
      • Principal Investigator: Elena Parvez, Dr.
    • Toronto, Ontario, Canada, M4N 3M5
      • Recruiting
      • Sunnybrook Health Sciences -Odette Cancer Centre
      • Contact: Carolyn Lim; Phone Number: 67219 416-480-5000; Email: carolyn.lim@sunnybrook.ca
      • Principal Investigator: Irene Karam, Dr
  • Quebec
    • Montréal, Quebec, Canada, H3T 1E2
      • Recruiting
      • Jewish General Hospital
      • Contact: Gladys El-Helou; Phone Number: 6581 514-340-8222; Email: gelhelou@jgh.mcgill.ca
      • Contact: Olga Prescornic; Phone Number: 23471 514-340-8222; Email: olga.prescornic.ccomtl@ssss.gouv.qc.ca
      • Principal Investigator: Thierry Muanza, Dr
      • Sub-Investigator: Mark Baski, Dr
    • Quebec City, Quebec, Canada, G1R 2J6
      • Recruiting
      • CHU de Québec - Université Laval
      • Contact: Josee Allard; Phone Number: 418-691-5264; Email: josee.allard@chudequebec.ca
      • Principal Investigator: Valerie Theberge, Dr
    • Trois-Rivières, Quebec, Canada, G8Z 3R9
      • Recruiting
      • Centre Hospitalier Trois Rivieres Ste-Marie
      • Contact: Marie-Eve Caron; Phone Number: 63239 819-697-3333; Email: marie-eve_caron_chrtr@ssss.gouv.qc.ca
      • Contact: Julie Samson; Phone Number: 64832 819-697-3333; Email: julie_samson_ciusssmcq@ssss.gouv.qc.ca
      • Principal Investigator: Rafika Dahmane, Dr

Participation Criteria

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

How is the study designed?

Number of groups / cohorts

1

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)	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	defined as time from registration to undergoing ipsilateral mastectomy.	5 years
Relapse free interval (RFI)	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)	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)	defined as time from registration to death from any cause.	5 years

Collaborators and Investigators

• Sponsor: Ontario Clinical Oncology Group (OCOG)
• 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

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): April 17, 2024
• Last Update Submitted That Met QC Criteria: April 16, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: Neoadjuvant chemotherapy; Clinically node negative breast cancer; Ipsilateral breast tumour recurrence
• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms
• 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