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

Recruiting now

Conditions studied: Breast Cancer

In brief

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

Key facts

Study ID

NCT05866458

Run by

Ontario Clinical Oncology Group (OCOG)

People needed

352

Starts

2024-03-12

Expected to finish

2031-10-01

Last updated by the study team

2026-06-17

Who can join

Age: 50 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify 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 qualify 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 it is running

• McGill University Health Centre (MUHC) — Montreal, Q, Canada (enrolling)
• Liverpool Hospital — Liverpool, New South Wales, Australia (enrolling)
• Mater Hospital Sydney — North Sydney, New South Wales, Australia (enrolling)
• Westmead Hospital — Westmead, New South Wales, Australia (enrolling)
• Centre Hospitalier Trois Rivieres Ste-Marie — Trois-Rivières, Quebec, Canada (enrolling)
• Tweed Valley Hospital — Cudgen, Cudgen, Australia (enrolling)
• Victorian Breast & Oncology Care (VBOC) — East Melbourne, Victoria, Australia (enrolling)
• St. Vincent's Hospital Melbourne — Melbourne, Victoria, Australia (enrolling)
• Maroondah Hospital — Box Hill, Australia (enrolling)
• Prince of Wales Hospital — Randwick, Australia (enrolling)
• Latrobe Regional Health — Traralgon, Australia (enrolling)
• BC Cancer - Centre for the North — Prince George, British Columbia, Canada (enrolling)
• Royal Victoria Regional Health Centre — Barrie, Ontario, Canada (enrolling)
• Juravinski Cancer Centre — Hamilton, Ontario, Canada (enrolling)
• Cancer Centre of Southeastern Ontario at Kingston — Kingston, Ontario, Canada (enrolling)
• Thunder Bay Regional Health Sciences Centre — Thunder Bay, Ontario, Canada (enrolling)
• Sunnybrook Health Sciences -Odette Cancer Centre — Toronto, Ontario, Canada (enrolling)
• CHUM - Centre Hospitalier de L'Université de Montréal — Montreal, Quebec, Canada (enrolling)
• Jewish General Hospital — Montreal, Quebec, Canada (enrolling)
• CHU de Quebec - Universite Laval — Québec, Quebec, Canada (enrolling)
• Centre hospitalier de Lanaudière — Saint-Charles-Borromée, Quebec, Canada (enrolling)
• Monash Medical Centre -Moorabbin — Bentleigh East, Victoria, Australia
• Royal Perth Hospital — Perth, Australia

Full record on ClinicalTrials.gov

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