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Clinical Trials in Canada / NCT01791829
Active, not recruiting Observational

A Prospective Cohort Study Evaluating Risk of Local Recurrence Following Breast Conserving Surgery and Endocrine Therapy in Low Risk Luminal A Breast Cancer

NCT01791829 · tracked via the Priya Life Science Canada tracker
Phase
Observational
Started
2013-07
Last updated
2026-06-17

Condition(s) studied

Breast Cancer

Study summary

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)

Trial sites (27)

FacilityCityRegionStatus
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

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Official registry record

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.

View NCT01791829 on ClinicalTrials.gov ↗ ← All trials in Canada