Recruiting
Radiation OmisSion in PAtients With CLinically Node Negative Breast Cancer Undergoing Lumpectomy
To de-escalate radiation therapy in women with breast cancer.
ClinicalTrials.gov IDNCT05866458
PhaseNot Applicable
Enrollment352
SponsorOntario Clinical Oncology Group (OCOG)
Age50 Years
SexFEMALE
Conditions studied
Breast Cancer
About this study
To de-escalate radiation therapy in women with breast cancer.
Primary outcomes
- Ipsilateral breast tumour recurrence (IBTR) (5 years)
Eligibility information
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 locations
- Tweed Valley Hospital, Cudgen, Cudgen 2487 Australia
- Liverpool Hospital, Liverpool, New South Wales 1871 Australia
- Mater Hospital Sydney, North Sydney, New South Wales 2060 Australia
- Westmead Hospital, Westmead, New South Wales 2145 Australia
- Royal Brisbane and Women's Hospital, Herston, Queensland 4029 Australia
- Princess Alexandra Hospital, Woolloongabba, Queensland 4102 Australia
- Monash Medical Centre -Moorabbin, Bentleigh East, Victoria 3165 Australia
- Victorian Breast & Oncology Care (VBOC), East Melbourne, Victoria 3002 Australia
- Peter MacCallum Cancer Centre, Melbourne, Victoria 3000 Australia
- St. Vincent's Hospital Melbourne, Melbourne, Victoria 3065 Australia
Showing 10 of 27 reported sites. See the official listing for all locations.
Before you participate: Varda Clinical is an independent discovery tool, not the study sponsor or a medical provider. Eligibility can only be determined by the official study team. Discuss potential risks and benefits with a qualified healthcare professional.
Source: ClinicalTrials.gov. Record last refreshed by Varda Clinical: 2026-09-27.