To de-escalate radiation therapy in women with breast cancer.
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.
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.
Written informed consent will be obtained from all eligible patients who agree to participate. Until the patient has been completely informed of the study, has freely consented to take part in the study and has signed and dated an informed consent form that has received documented approval by an authorized Research Ethics Board (REB), no study related assessments, including those required for screening can be performed.
Cohort
Prospective
Not listed
Ipsilateral breast tumour recurrence (IBTR)
defined as ipsilateral recurrence (invasive or insitu) in the ipsilateral breast or chest wall. Histological evidence of IBTR is required. All such events will be reviewed by a central adjudication committee.
Mastectomy free interval
defined as time from registration to undergoing ipsilateral mastectomy.
Relapse free interval (RFI)
defined as time from registration to recurrence of invasive disease in the ipsilateral breast, regional nodes (axilla, supraclavicular, or internal mammary), distant areas beyond local or regional limits (distant recurrence), and death from breast cancer.
Disease free survival (DFS)
defined as time from registration to in breast invasive tumour recurrence, regional invasive recurrence, distant recurrence, contralateral breast cancer, second primary non-breast cancers, death from breast cancer, and death from non-breast cancer.
Overall survival (OS)
defined as time from registration to death from any cause.
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Ontario Clinical Oncology Group (OCOG)
Lead sponsor
Canadian Institutes of Health Research (CIHR)
Collaborator
Hamilton Health Sciences Corporation
Collaborator
