To de-escalate radiation therapy in women with breast cancer.
The study is a prospective, multi-center, single arm cohort study of omission of adjuvant whole breast radiation therapy (WBRT) following breast conserving surgery (BCS) in patients with a pathological complete response (pCR) following neoadjuvant chemotherapy (NAC). Eligible and consenting female patients with newly diagnosed T1-3 node negative breast cancer with no clinical evidence of distant metastatic disease, who have been treated with NAC, BCS and axillary staging surgery with final pathology demonstrating a pCR (ypT0N0) will be enrolled to the study and followed. The first analysis is planned when follow-up is a median of 5 years. Study participants will not receive adjuvant WBRT, the current standard of care. The primary outcome is ipsilateral breast tumour recurrence (IBTR) at median 5-year follow-up. Study participants will be followed and assessed for local recurrence, regional recurrence, distant recurrence, DFS and OS. In addition, any additional breast cancer treatments received by the participant for the first recurrence event including repeat BCS, mastectomy, additional systemic therapy and radiation therapy (RT) will be documented. The planned sample size is 352 study participants.
Study Type
OBSERVATIONAL
Enrollment
352
BC Cancer - Centre for the North
Prince George, British Columbia, Canada
RECRUITINGRoyal Victoria Regional Health Centre
Barrie, Ontario, Canada
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.
Time frame: 5 years
Mastectomy free interval
defined as time from registration to undergoing ipsilateral mastectomy.
Time frame: 5 years
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.
Time frame: 5 years
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.
Time frame: 5 years
Overall survival (OS)
defined as time from registration to death from any cause.
Time frame: 5 years
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Juravinski Cancer Centre
Hamilton, Ontario, Canada
RECRUITINGCancer Centre of Southeastern Ontario at Kingston
Kingston, Ontario, Canada
RECRUITINGThunder Bay Regional Health Sciences Centre
Thunder Bay, Ontario, Canada
RECRUITINGSunnybrook Health Sciences -Odette Cancer Centre
Toronto, Ontario, Canada
RECRUITINGCHUM - Centre Hospitalier de L'Université de Montréal
Montreal, Quebec, Canada
RECRUITINGJewish General Hospital
Montreal, Quebec, Canada
RECRUITINGCHU de Quebec - Universite Laval
Québec, Quebec, Canada
RECRUITINGCentre hospitalier de Lanaudière
Saint-Charles-Borromée, Quebec, Canada
RECRUITING...and 2 more locations