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

What this study is about

To de-escalate radiation therapy in women with breast cancer.

Who can join (things the study team will check)

✅ You may be able to join if…

• 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)].

🚫 You may not be able to join if…

• 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.
• 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.

Where this trial is running

• Tweed Valley Hospital, Cudgen, Cudgen, Australia
• Liverpool Hospital, Liverpool, New South Wales, Australia
• Mater Hospital Sydney, North Sydney, New South Wales, Australia
• Westmead Hospital, Westmead, New South Wales, Australia
• Monash Medical Centre -Moorabbin, Bentleigh East, Victoria, Australia
• Victorian Breast & Oncology Care (VBOC), East Melbourne, Victoria, Australia
• St. Vincent's Hospital Melbourne, Melbourne, Victoria, Australia
• Maroondah Hospital, Box Hill, Australia
• Royal Perth Hospital, Perth, Australia
• Prince of Wales Hospital, Randwick, Australia
• Latrobe Regional Health, Traralgon, Australia
• BC Cancer - Centre for the North, Prince George, British Columbia, Canada

+ 11 more sites.

Who to contact

Adrianne Van Dam · 905-527-2299 · avandam@mcmaster.ca

It's completely normal to call and ask questions before deciding anything. Mention the study ID: NCT05866458.