Breast CancerROSALIENCT05866458
Radiation OmisSion in PAtients With CLinically Node Negative Breast Cancer Undergoing Lumpectomy
An observational study of Breast Cancer, run by Ontario Clinical Oncology Group (OCOG) at 27 sites in 2 countries.
Trial summary
To de-escalate radiation therapy in women with breast cancer. Read more about this study
- Who is it for?
- Ages 50 years and older, women only
- Conditions the study is for
- Breast Cancer
- How many people
- 352 participants
- Where
- 27 sitesin 2 countries
- Study dates
- 12 Mar 2024to Oct 2031
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- Female patient with a new histological diagnosis of clinical T1-3 N0 breast cancer (any tumour sub-type).
- Negative lymph node involvement at initial presentation, documented by imaging (US or MRI), fine needle aspiration (FNA) or core needle biopsy.
- Treated with a minimum of 8 weeks NAC, with patients with Her2+ disease receiving targeted anti-Her2+ therapy.
- Marker clip placed in the tumour bed prior to or during neoadjuvant chemotherapy when the tumour can still be identified.
- Treated by BCS with complete excision of the tumour bed and axillary staging surgery (either sentinel lymph node biopsy or axillary lymph node dissection).
- Final pathology demonstrating a pCR [defined as absence of residual invasive and in-situ breast cancer within the breast or lymph nodes (ypT0N0)].
Who cannot join
- Age less than 50 years.
- Inflammatory breast cancer or breast cancer invading the skin or chest wall (T4 disease).
- Multicentric disease (i.e., breast cancer involving more than one quadrant in the same breast).
- Prior history of ipsilateral or contralateral in-situ or invasive breast cancer. Patients with a history of lobular carcinoma in-situ (LCIS) are ineligible.
- Synchronous contralateral in-situ or invasive breast cancer.
- BRCA (breast cancer gene) 1 or 2 genetic mutation carrier, or other genetic mutation present associated with increased risk of breast cancer.
Show all 12Show fewer
- 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.
- Inability to complete entire course of neoadjuvant therapy (minimum of 8 weeks of treatment).
- Patients with HR+ (hormone receptor) disease who are not planned to have endocrine therapy initiated.
- Patients with Her2+ disease who have not received or are not planned to receive Her2 targeted therapy.
- ECOG (Eastern Cooperative Oncology Group) performance status > 3.
- Inability to provide informed consent.
Trial locations and contacts
27 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
27 sites in 2 countries
Australia15 sites, 15 recruiting
- Recruiting
Monash Medical Centre -Moorabbin
Bentleigh East, Victoria, 3165
Divya Arora, 03 9928 8994, divya.arora@petermac.org
Kate Hunter, 0409 546 213, kate.hunter@petermac.org
- Recruiting
Maroondah Hospital
Box Hill, 3128
Courtney Cooper, 9094 9503, courtney.cooper@monash.edu
Armal George, armal.george@monash.edu
- Recruiting
Tweed Valley Hospital
Cudgen, Cudgen, 2487
Rachael Rowse, rachael.rowse@health.nsw.gov.au
Katherina Farr, Dr
- Recruiting
Victorian Breast & Oncology Care (VBOC)
East Melbourne, Victoria, 3002
Angela Benson, 61 3 9417 4666, angela@vboc.com.au
Kayte Robinson, 61 3 9471 4666, kayte@vboc.com.au
- Recruiting
Royal Brisbane and Women's Hospital
Herston, Queensland, 4029
Dianna Lewis, 07 3647 0209, dianna.lewis@health.qld.gov.au
Laura Chazikantis, 07 3647 0364, laura.chazikantis@health.qld.gov.au
- Recruiting
Liverpool Hospital
Liverpool, New South Wales, 1871
Michaela Beavan, 0429 094 402, michaela.beavan@health.nsw.gov.au
Toobah Farooqi, 0429 094 402, toobah.farooqi@health.nsw.gov.au
- Recruiting
Peter MacCallum Cancer Centre
Melbourne, Victoria, 3000
Bianca de Dios, 03 8559 7938, bianca.dedios@petermac.org
Divya Arora, 03 9928 8994, divya.arora@petermac.org
- Recruiting
St. Vincent's Hospital Melbourne
Melbourne, Victoria, 3065
Suraya Roslan, 0447 190 335, suraya.roslan@svha.org.au
Emilie Linahan, 61 3 9231 3176, emilie.linahan@svha.org.au
- Recruiting
Sir Charles Gairdner Hospital
Nedlands, Western Australia, 6009
Elizabeth Kernutt, 08 6383 3200, elizabeth.kernutt@health.wa.gov.au
Eva Arneric, 08 6383 3195, eva.arneric@health.wa.gov.au
- Recruiting
Mater Hospital Sydney
North Sydney, New South Wales, 2060
Julie Hoffman, 61 2 9911 7312, julia.hoffman@melanoma.org.au
Mona Martyn-Smith, 61 2 9900 7776, mona.martyn-smith@svha.org.au
- Recruiting
Royal Perth Hospital
Perth, 6000
Vanitha Budhavaram, 61 4 1719 7359, vanitha.budhavaram@health.wa.gov.au
Samantha Chen, Dr
- Recruiting
Prince of Wales Hospital
Randwick, 2031
Anjana Sanjay, 02 98325120, anjana.sanjay@health.nsw.gov.au
Boon Chua, Dr
- Recruiting
Latrobe Regional Health
Traralgon, 3844
Genevieve Truscott, 03 5173 3166, genevieve.truscott@lrh.com.au
Tahlia McDevitt, 03 5173 8166, tahlia.mcdevitt@lrh.com.au
- Recruiting
Westmead Hospital
Westmead, New South Wales, 2145
Kirsten Connolly, 61 2 8890 8539, kirsten.gadsby@health.nsw.gov.au
Luke Isaacs, 61 2 8890 8540, luke.isaacs@health.nsw.gov.au
- Recruiting
Princess Alexandra Hospital
Woolloongabba, Queensland, 4102
David Hickey, 07 3840 3219, david.hickey@health.qld.gov.au
Nicole Lovell, 07 3176 1473, nicole.lovell@health.qld.gov.au
Canada12 sites, 12 recruiting
- Recruiting
Royal Victoria Regional Health Centre
Barrie, Ontario, L4M 6M2
Sharmaine Ali, 705-728-9090, alis@rvh.on.ca
Christiaan Stevens, Dr
- Recruiting
Juravinski Cancer Centre
Hamilton, Ontario, L8V 5C2
Meaghan Preston, 905-521-2100 ext. 47106, prestm1@mcmaster.ca
Elena Parvez, Dr.
- Recruiting
Cancer Centre of Southeastern Ontario at Kingston
Kingston, Ontario, K7L 5P9
Carrie Lindsay, 613-549-6666 ext. x6654, carrie.lindsay@kingstonhsc.ca
Timothy E Owen, Dr
- Recruiting
CHUM - Centre Hospitalier de L'Université de Montréal
Montreal, Quebec, H2L 4M1
Eva-Sabrina Nkurunziza, 514-890-8000 ext. ext 24506, eva-sabrina.nkurunziza.chum@ssss.gouv.qc.ca
Jean-Marc Bourque, Dr
- Recruiting
Jewish General Hospital
Montreal, Quebec, H3T 1E2
Olga Prescornic, 514-340-8222 ext. 23471, olga.prescornic.ccomtl@ssss.gouv.qc.ca
Thierry Muanza, Dr
- Recruiting
McGill University Health Centre (MUHC)
Montreal, Q, H4A 3J1
Marianna Perna, 514-934-1934 ext. 43191, marianna.perna@muhc.mcgill.ca
Christine Lambert, Dr
- Recruiting
BC Cancer - Centre for the North
Prince George, British Columbia, V2M 7E9
Kaitlin Earl, 250-645-7300 ext. 687427, Kaitlin.Earl@bccancer.bc.ca
Andre Gouveia, Dr
- Recruiting
CHU de Quebec - Universite Laval
Québec, Quebec, G1R 2J6
Josee Allard, 418-691-5264, josee.allard@chudequebec.ca
Valerie Theberge, Dr
- Recruiting
Centre hospitalier de Lanaudière
Saint-Charles-Borromée, Quebec, J6E 6J2
Isabelle Bouchard, 579-593-1172, isabelle.bouchard.cissslan@ssss.gouv.qc.ca
Dominique Morency, Dr
- Recruiting
Thunder Bay Regional Health Sciences Centre
Thunder Bay, Ontario, P7B 6V4
Martina Agostino, 807-684-7566, martina.agostino@tbh.net
Di-anne Salo, 807-684-7566, di-anne.salo@tbh.net
- Recruiting
Sunnybrook Health Sciences -Odette Cancer Centre
Toronto, Ontario, M4N 3M5
Carolyn Lim, 416-480-5000 ext. 67219, carolyn.lim@sunnybrook.ca
Irene Karam, Dr
- Recruiting
Centre Hospitalier Trois Rivieres Ste-Marie
Trois-Rivières, Quebec, G8Z 3R9
Marie-Eve Caron, 819-697-3333 ext. 63239, marie-eve_caron_chrtr@ssss.gouv.qc.ca
Julie Samson, 819-697-3333 ext. 64832, julie_samson_ciusssmcq@ssss.gouv.qc.ca
About this study
Official title: 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.
Read the 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.
- Conditions
- Breast Cancer
- Keywords
- Clinically node negative breast cancer, Ipsilateral breast tumour recurrence, Neoadjuvant chemotherapy
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 5 years
Secondary outcomes (4)
Mastectomy free interval
defined as time from registration to undergoing ipsilateral mastectomy.
Measured: 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.
Measured: 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.
Measured: 5 years
Overall survival (OS)
defined as time from registration to death from any cause.
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2023
- Study start12 Mar 2024
- Primary completionOct 2031 (estimated)
- Study completionOct 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 352 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ontario Clinical Oncology Group (OCOG)
- Sponsor type
- University, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR), Hamilton Health Sciences Corporation
- Responsible party
- Sponsor
- Investigators
- Elena Parvez, MD, Principal investigator, Juravinski Cancer CentreThierry Muanza, MD, Principal investigator, Jewish General HospitalMark Basik, MD, Principal investigator, Jewish General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05866458
- Sponsor's protocol ID
- OCOG-2022-ROSALIE
- Acronym
- ROSALIE
- Status last verified
- Oct 2026
- First submitted
- 10 May 2023
- Last updated
- 13 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Radiation OmisSion in PAtients With CLinically Node Negative Breast Cancer Undergoing Lumpectomy and With a PathologIc Complete REsponse After Neoadjuvant Chemotherapy
- ClinicalTrials.gov ID
- NCT05866458
- Acronym / sponsor ID
- ROSALIE / OCOG-2022-ROSALIE
- Conditions
- Breast Cancer
- Keywords
- Clinically node negative breast cancer, Ipsilateral breast tumour recurrence, Neoadjuvant chemotherapy
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 352 participants (estimated)
- Lead sponsor
- Ontario Clinical Oncology Group (OCOG)University, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR), Hamilton Health Sciences Corporation
- Study start
- 12 Mar 2024 (actual)
- Primary completion
- Oct 2031 (estimated)
- Study completion
- Oct 2031 (estimated)
- First posted
- 19 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To de-escalate radiation therapy in women with 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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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). |
Who may qualify
- Ages
- 50 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (6 listed)
- Female patient with a new histological diagnosis of clinical T1-3 N0 breast cancer (any tumour sub-type).
- Negative lymph node involvement at initial presentation, documented by imaging (US or MRI), fine needle aspiration (FNA) or core needle biopsy.
- Treated with a minimum of 8 weeks NAC, with patients with Her2+ disease receiving targeted anti-Her2+ therapy.
- Marker clip placed in the tumour bed prior to or during neoadjuvant chemotherapy when the tumour can still be identified.
- Treated by BCS with complete excision of the tumour bed and axillary staging surgery (either sentinel lymph node biopsy or axillary lymph node dissection).
Key exclusion criteria (12 listed)
- Age less than 50 years.
- Inflammatory breast cancer or breast cancer invading the skin or chest wall (T4 disease).
- Multicentric disease (i.e., breast cancer involving more than one quadrant in the same breast).
- Prior history of ipsilateral or contralateral in-situ or invasive breast cancer. Patients with a history of lobular carcinoma in-situ (LCIS) are ineligible.
- Synchronous contralateral in-situ or invasive breast cancer.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
4 secondary outcomes
Mastectomy free interval
Time frame: 5 years
Relapse free interval (RFI)
Time frame: 5 years
Disease free survival (DFS)
Time frame: 5 years
Overall survival (OS)
Time frame: 5 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Oct 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Elena Parvez, MD principal investigator
Juravinski Cancer Centre
Thierry Muanza, MD principal investigator
Jewish General Hospital
Mark Basik, MD principal investigator
Jewish General Hospital
27 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Cancer, run by Ontario Clinical Oncology Group (OCOG) at 27 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 13 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 27 sites in Australia, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Adrianne Van Dam (905-527-2299 ext. 42607, avandam@mcmaster.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Ipsilateral breast tumour recurrence (IBTR) (time frame: 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Oct 2026.