A Prospective Cohort Study Evaluating Risk of Local Recurrence Following Breast Conserving Surgery and Endocrine Therapy in Low Risk Luminal A Breast Cancer
This is a multicentre, single-arm prospective cohort study evaluating risk of ipsilateral breast tumour recurrence(IBTR) following breast conserving surgery (BCS) in a group of women postulated to be at low risk for recurrence. Women with luminal A breast cancer determined by immunohistochemical(IHC) and other low risk clinical testing (see below) will be treated with endocrine therapy (tamoxifen or aromatase inhibitor) for five years and will not be treated with breast irradiation (BI). Subjects will be followed for 10 years and will be assessed for recurrent disease, new primary cancer and survival.
Eligibility
Sex
FEMALE
Min age
55 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria:
1. Female patient \> or = 55 years of age with a new diagnosis of invasive carcinoma of the breast (ductal, tubular or mucinous only) with primary tumour \< or =2cm on microscopic exam, with no evidence of metastatic disease;
2. ER positive (\> or =1%) and PR positive (\>20%) and HER2 negative (Immunohistochemical (IHC) or In Situ Hybridization (ISH) approach);
3. Treated by BCS with microscopically clear resection margins \> or = 1mm for invasive and non-invasive disease or no residual disease on re-excision;
4. Negative axillary node involvement determined by sentinel node biopsy or axillary node dissection.
Exclusion Criteria:
1. Clinical or pathological evidence of T4 disease (i.e. extension to chest wall, skin involvement, peau d'orange, or inflammatory breast cancer).
2. Multifocal or multicentric disease.
3. Evidence of an extensive intraductal component (defined as a tumour that is composed of 25% or more of DCIS and the DCIS extends beyond the gross dimensions of the tumour), or disease limited to micro invasion only.
4. Grade 3 histology for invasive disease
5. Evidence of lymphovascular invasion.
6. Evidence of disease on pre-operative mammogram, aside from primary cancer treated by breast conserving surgery.
7. Bilateral malignancy of the breast (synchronous or metachronous).
8. Known BRCA 1 or 2 mutations.
9. History of non-breast cancer malignancies if not disease free for \> 5 years and considered low risk of recurrence with the exception of treated carcinoma in-situ of the cervix, endometrium or colon, melanoma in-situ and basal or squamous cell carcinoma of the skin.
10. Serious non-malignant disease associated with a life expectancy \< 10 years.
11. Inability to be treated with or to tolerate endocrine therapy.
12. Psychiatric or addictive disorder, which would preclude obtaining informed consent or adherence to protocol.
13. Geographic inaccessibility for follow-up.
14. Inability to understand or unable to provide written informed consent.
15. Inability to be registered on study within 12 weeks of the last surgical procedure on the breast.
16. Central testing for Ki67 \> 13.25% consistent with the luminal B subtype
Primary outcome measure(s)
Ipsilateral Breast Tumour Recurrence (IBTR) — 5 years The primary outcome is IBTR defined as recurrent invasive or in-situ cancer in the ipsilateral breast during follow-up. Histological evidence of recurrence will be required. All recurrences will be reviewed by a central adjudication committee.
Trial sites (27)
Facility
City
Region
Status
Tom Baker Cancer Centre
Calgary
Alberta
Abbotsford Centre
Abbotsford British Columbia
British Columbia
BC Cancer Agency, Centre for the North
Prince George
British Columbia
BCCA - Vancouver Centre
Vancouver
British Columbia
BC Cancer Agency
Victoria
British Columbia
Cancer Care Manitoba
Winnipeg
Manitoba
Royal Victoria Regional Health Centre
Barrie
Ontario
Northeastern Ontario Regional Cancer Centre
Greater Sudbury
Ontario
Juravinski Cancer Centre
Hamilton
Ontario
Cancer Centre of Southern Ontario at Kingston
Kingston
Ontario
Grand River Regional Cancer Centre
Kitchener
Ontario
London Regional Cancer Centre
London
Ontario
R.S. McLaughlin Durham Regional Cancer Centre
Oshawa
Ontario
Ottawa Regional Cancer Centre
Ottawa
Ontario
Algoma District Cancer Program
Sault Ste. Marie
Ontario
Niagara Health System
St. Catharines
Ontario
Thunder Bay Regional Health Sciences
Thunder Bay
Ontario
Sunnybrook Health Sciences Centre
Toronto
Ontario
Princess Margaret Cancer Centre
Toronto
Ontario
Centre integre de sante et de services sociaux de laval (CISSS de Laval)
Laval
Quebec
CHUM - Hopital Notre Dame
Montreal
Quebec
The Jewish General Hospital
Montreal
Quebec
McGill University Health Centre
Montreal
Quebec
CHUQ - Pavillon Hotel-Dieu de Quebec
Québec
Quebec
CHUS - Hopital Fleurimont
Sherbrooke
Quebec
The Allan Blair Cancer Centre
Regina
Saskatchewan
Saskatoon Cancer Centre
Saskatoon
Saskatchewan
More Ontario Clinical Oncology Group (OCOG) trials in Canada
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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