Recruiting
Phase 3

Partial Breast Irradiation

Sponsor:

Ontario Clinical Oncology Group (OCOG)

Code:

NCT05417516

Conditions

Breast Neoplasm Female

Radiotherapy

Cosmetic Outcome

Eligibility Criteria

Sex: Female

Age: 50 - 70+

Healthy Volunteers: Not accepted

Interventions

Whole Breast Irradiation (WBI)

Partial Breast Irradiation (PBI)

Study Details

Brief summary:

The primary objective of this study is to determine in women with node negative BC ≤3cm in size, if PBI compared to WBI, both given once-a-day over 1 week following BCS, is non-inferior for LR and reduces adverse cosmesis. The primary outcomes are LR and patient-assessed cosmesis at 3 years post randomization.

Conditions

Breast Neoplasm Female

Radiotherapy

Cosmetic Outcome

Study ID

NCT05417516

Start date

Nov 20, 2023

Status verified date

Jun, 2026

Completion date

Nov, 2031

Anticipated

Primary completion date

Nov, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 50 - 70+

Healthy Volunteers: Not accepted

Inclusion Criteria:

For inclusion in this study, patients must fulfill all of the following criteria:

1. Female with a new histological diagnosis of invasive carcinoma of the breast with no evidence of metastatic disease (see AJCC TNM Cancer Staging, Appendix II).
2. Treated by BCS with microscopically clear resection margins >= 1mm for invasive and non-invasive disease or no residual disease on re-excision.
3. Negative axillary node involvement as determined by either sentinel lymph node biopsy or axillary node dissection or clinical assessment with a negative axillary ultrasound and/or biopsy, for women with unifocal tumours <= 2cm, histologic grade 1 or 2, ER or PR+ and HER2-ve that are being planned for endocrine therapy

Exclusion Criteria:

Patients who satisfy any of the following exclusion criteria are NOT eligible for this study:

1. Age less than 50 years.
2. Known to be BRCA 1 and/or BRCA 2 positive.
3. Tumour size >3cm in greatest diameter on pathological examination.
4. Evidence of extensive intraductal component (EIC) (defined as an invasive tumour with a ductal carcinoma in situ (DCIS) component comprising at least 25% and extending beyond the invasive component to surrounding normal breast tissue) with the following exception: smaller tumours with EIC where the combined size (of the invasive and DCIS components) are <= 3cm remain eligible
5. Evidence of a DCIS component > 3cm
6. Lobular carcinoma only.
7. More than one primary tumour in different quadrants of the same breast (patients with multifocal breast cancer are eligible).
8. Synchronous or previous contralateral breast cancer (patients with contralateral DCIS or LCIS are eligible).
9. History of non-breast malignancy within the last 5 years other than treated non-melanoma skin cancer or treated in-situ carcinoma.
10. Known pregnancy or currently lactating.
11. Inability to localize tumour bed on CT planning (no evidence of surgical clips or seroma).
12. Inability to plan the patient for the experimental technique.

Study Design

Enrollment

910 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: Whole Breast Irradiation (WBI)

26 Gy in 5 fractions to the whole breast

experimental: Partial Breast Irradiation (PBI)

26 Gy in 5 fractions to the tumour bed with a margin of normal tissue

Interventions

Whole Breast Irradiation (WBI)

The dose fractionation and prescription is 26Gy in 5 fractions to the PTV once per day over 5-7 days (due to holiday weekends up to 8 days will be acceptable).

Partial Breast Irradiation (PBI)

The dose fractionation and prescription is 26Gy in 5 fractions to the PTV prescribed at the isocentre of the treatment fields treated once per day over 5-7 days (due to holiday weekends up to 8 days will be acceptable).

Primary outcome measure

  • Local Recurrence [ Time Frame: Annually for 5 years post-randomization ]
  • Patient Assessment Cosmesis at 3 years [ Time Frame: 3 and 5 years post-randomization ]

Central Contacts and Locations

Central contacts

Locations

Arthur J. E. Child Comprehensive Cancer Centre-Clinical Research Unit

Recruiting

Calgary, Alberta, Canada

Contacts

Principal Investigator:

Jeffrey Cao

QEII HSC - Nova Scotia Cancer Centre

Recruiting

Halifax, Nova Scotia, Canada

Contacts

Principal Investigator:

Maureen Nolan

Royal Victoria Regional Health Centre

Recruiting

Barrie, Ontario, Canada

Contacts

Sujata Pokhrel

pokhrels@rvh.on.ca

Christine DiMarco

dimarcoc@rvh.on.ca

Principal Investigator:

Jessica Conway

Juravinski Cancer Centre

Recruiting

Hamilton, Ontario, Canada

Contacts

Kaelyn Ridgway

ridgwayk@hhsc.ca

Principal Investigator:

Do-Hoon Kim

London Regional Cancer Centre

Recruiting

London, Ontario, Canada

Contacts

Principal Investigator:

Francisco Perera, MD

Stronach (Southlake) Regional Health Centre

Recruiting

Newmarket, Ontario, Canada

Contacts

Principal Investigator:

Tatiana Conrad

Algoma District Cancer Program

Recruiting

Sault Ste. Marie, Ontario, Canada

Contacts

Natalie Walde

walden@sah.on.ca

Principal Investigator:

Stephane Thibodeau

Princess Margaret Hospital

Recruiting

Toronto, Ontario, Canada

Contacts

Principal Investigator:

Jennifer Croke

Toronto-Sunnybrook Health Sciences Centre - Odette Cancer Centre

Recruiting

Toronto, Ontario, Canada

Contacts

Windsor Regional Cancer Centre

Recruiting

Windsor, Ontario, Canada, N8W2X3

Contacts

Principal Investigator:

Khalid Hirmiz, MD

CSSS Champlain - Charles LeMoyne

Recruiting

Greenfield Park, Quebec, Canada

Contacts

Principal Investigator:

Marjory Jolicoeur, MD

CHUM - Centre Hospitalier de L'Université de Montréal

Recruiting

Montreal, Quebec, Canada, H2L 4M1

Contacts

Principal Investigator:

Jean-Marc Bourque

McGill University Health Centre

Recruiting

Montreal, Quebec, Canada

Contacts

Principal Investigator:

Tarek Hijal

CHUQ-Pavillon Hotel-Dieu de Quebec

Recruiting

Québec, Quebec, Canada

Contacts

Principal Investigator:

Valerie Theberge

CHUS-Hopital Fleurimont

Recruiting

Sherbrooke, Quebec, Canada, J1H5N4

Contacts

Principal Investigator:

Sawnya Provencher

Centre Intégré Universitaire de Santé et de Services Sociaux de la Mauricie-Centre-du-Québec (CIUSSS MCQ)

Recruiting

Trois-Rivières, Quebec, Canada, G8Z 3R9

Contacts

Principal Investigator:

Francois Vincent

Saskatoon Cancer Centre

Recruiting

Saskatoon, Saskatchewan, Canada, S7N 4H4

Contacts

Principal Investigator:

Duc Le, MD

More Information

Sponsor

Ontario Clinical Oncology Group (OCOG)

Last update posted

Jul 7, 2026

Last verified

Jun, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Ontario Clinical Oncology Group (OCOG) on 2026-07-07.