Phase 3 Breast Cancer Trial, RecruitingNCT05417516Sponsor: Ontario Clinical Oncology Group (OCOG)Condition: Breast Cancer
Printed from Voxsanity (voxsanity.com.au) — NCT05417516 — Data sourced from ClinicalTrials.gov. Verify directly with the trial site before attending. Not medical advice.
AI generated eligibility summary.
Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source.
How we use AI
Who might be able to join this trial:
Women who have been newly diagnosed with invasive breast cancer (confirmed by tissue testing) with no sign that the cancer has spread to other parts of the body
Women who have had breast-conserving surgery (surgery that removes the tumour but keeps most of the breast) where the edges of the removed tissue are clear of cancer cells by at least 1mm, or where a follow-up surgery showed no remaining cancer cells
Women with no cancer found in the lymph nodes under the arm, confirmed by one of several testing methods — with a specific exception for women with smaller, lower-grade, hormone-sensitive, HER2-negative tumours where a clinical assessment with ultrasound and/or biopsy may be sufficient (confirm with trial site)
Who may not be able to join:
Women under 50 years of age
Women who are known to carry a BRCA1 and/or BRCA2 gene mutation
Women whose tumour measured more than 3cm at its widest point based on the tissue examined after surgery
Women whose cancer shows a significant spread of a non-invasive cancer type (called DCIS) into the surrounding breast tissue, unless the total combined size of both cancer components is 3cm or smaller
Women who have a DCIS component larger than 3cm
Women whose cancer is lobular carcinoma only (a specific type of breast cancer)
Women who have more than one primary tumour located in different sections of the same breast (note: multiple tumours within the same section of the breast may still be eligible — confirm with trial site)
Women who have, or have previously had, cancer in the other breast at the same time — though a history of certain non-invasive findings (DCIS or LCIS) in the other breast may still be eligible (confirm with trial site)
Women who have had another type of cancer (other than certain treated skin cancers or treated non-invasive cancers) within the last 5 years
Women who are pregnant or currently breastfeeding
Women where the surgical site cannot be clearly identified on the CT scan used for treatment planning (for example, if there are no surgical markers or fluid collection visible)
Women whose treatment plan cannot be set up to meet the requirements of the experimental treatment technique being tested in this trial
Important: Always verify eligibility with the trial site directly before applying.
Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.
This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 27 July 2026
Phase 3: approximately ~65% of drugs entering this phase reach regulatory approval, based on published industry-wide historical data. This is not specific to this trial.
Phase success rates shown are historical industry-wide averages based on published data. They are not a prediction for this specific trial or your individual situation.
Contact this trial
Principal Investigator: Timothy Whelan, M.D., Juravinski Cancer Centre and McMaster University
GenesisCare St Andrew's, Adelaide, South Australia
(08) 8228 6700
GenesisCare Bedford Park, Bedford Park, South Australia
GenesisCare Wembley, Wembley, Washington
GenesisCare Fiona Stanley Hospital, Murdoch, Western Austrailia
(08) 6318 2882
GenesisCare Hollywood, Nedlands, Western Australia
(08) 9286 8800
Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.
GP referral letter
Print a one-page summary to share with your doctor.
Voxsanity
Clinical trials and treatments, explained plainly · voxsanity.com.au
Date:
To: My Doctor
Re: Clinical trial enquiry
I am writing to enquire about the following clinical trial which may be relevant to my care:
Trial: NCT05417516
Sponsor: Ontario Clinical Oncology Group (OCOG)
Phase: Phase 3
Status: Recruiting
Condition: Breast Cancer
Trial contact: 905-527-2299
More information: https://clinicaltrials.gov/study/NCT05417516
Eligibility summary (AI generated)
Written by an AI model from the ClinicalTrials.gov eligibility criteria and checked on a sample basis. Please confirm against the original criteria.
Who might be able to join this trial:
Women who have been newly diagnosed with invasive breast cancer (confirmed by tissue testing) with no sign that the cancer has spread to other parts of the body
Women who have had breast-conserving surgery (surgery that removes the tumour but keeps most of the breast) where the edges of the removed tissue are clear of cancer cells by at least 1mm, or where a follow-up surgery showed no remaining cancer cells
Women with no cancer found in the lymph nodes under the arm, confirmed by one of several testing methods — with a specific exception for women with smaller, lower-grade, hormone-sensitive, HER2-negative tumours where a clinical assessment with ultrasound and/or biopsy may be sufficient (confirm with trial site)
Who may not be able to join:
Women under 50 years of age
Women who are known to carry a BRCA1 and/or BRCA2 gene mutation
Women whose tumour measured more than 3cm at its widest point based on the tissue examined after surgery
Women whose cancer shows a significant spread of a non-invasive cancer type (called DCIS) into the surrounding breast tissue, unless the total combined size of both cancer components is 3cm or smaller
Women who have a DCIS component larger than 3cm
Women whose cancer is lobular carcinoma only (a specific type of breast cancer)
Women who have more than one primary tumour located in different sections of the same breast (note: multiple tumours within the same section of the breast may still be eligible — confirm with trial site)
Women who have, or have previously had, cancer in the other breast at the same time — though a history of certain non-invasive findings (DCIS or LCIS) in the other breast may still be eligible (confirm with trial site)
Women who have had another type of cancer (other than certain treated skin cancers or treated non-invasive cancers) within the last 5 years
Women who are pregnant or currently breastfeeding
Women where the surgical site cannot be clearly identified on the CT scan used for treatment planning (for example, if there are no surgical markers or fluid collection visible)
Women whose treatment plan cannot be set up to meet the requirements of the experimental treatment technique being tested in this trial
Important: Always verify eligibility with the trial site directly before applying.
Access in Australia: A treatment being studied in a clinical trial is generally not yet listed on the PBS. Where a medicine is not approved or not available through a trial, the TGA Special Access Scheme may allow a doctor to access unapproved therapeutic goods for individual patients. See voxsanity.com.au/sas-navigator/ for a plain English explainer.
This information was sourced from ClinicalTrials.gov via Voxsanity (data last synced 27 July 2026). It is not medical advice. Please verify the trial's current status directly with the trial site before acting.
Trial details
Status
Recruiting
Phase
Phase 3
Sponsor
Ontario Clinical Oncology Group (OCOG)
Registry
ClinicalTrials.gov
Start date
20 November 2023
Est. completion
1 November 2029
Where this trial is recruiting
🇦🇺 Australia
🇨🇦 Canada
12 site(s) in Australia. Confirm current status and contact details directly with the trial site.
Primary endpoints
Local Recurrence; Patient Assessment Cosmesis at 3 years
Can't join this trial?
Expanded access pathways
If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.
Data last synced from ClinicalTrials.gov: 27 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.
Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.