Status:
ACTIVE_NOT_RECRUITING
A Prospective Cohort Study Evaluating Risk of Local Recurrence Following Breast Conserving Surgery and Endocrine Therapy in Low Risk Luminal A Breast Cancer
Lead Sponsor:
Ontario Clinical Oncology Group (OCOG)
Collaborating Sponsors:
British Columbia Cancer Agency
Conditions:
Breast Cancer
Eligibility:
FEMALE
55+ years
Brief 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 ...
Detailed Description
The independent prognostic ability of the luminal A subtype has been demonstrated in two retrospective analyses of prospective trials and suggests that luminal A combined with other known clinical pro...
Eligibility Criteria
Inclusion
- 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;
- ER positive (\> or =1%) and PR positive (\>20%) and HER2 negative (Immunohistochemical (IHC) or In Situ Hybridization (ISH) approach);
- Treated by BCS with microscopically clear resection margins \> or = 1mm for invasive and non-invasive disease or no residual disease on re-excision;
- Negative axillary node involvement determined by sentinel node biopsy or axillary node dissection.
Exclusion
- Clinical or pathological evidence of T4 disease (i.e. extension to chest wall, skin involvement, peau d'orange, or inflammatory breast cancer).
- Multifocal or multicentric disease.
- 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.
- Grade 3 histology for invasive disease
- Evidence of lymphovascular invasion.
- Evidence of disease on pre-operative mammogram, aside from primary cancer treated by breast conserving surgery.
- Bilateral malignancy of the breast (synchronous or metachronous).
- Known BRCA 1 or 2 mutations.
- 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.
- Serious non-malignant disease associated with a life expectancy \< 10 years.
- Inability to be treated with or to tolerate endocrine therapy.
- Psychiatric or addictive disorder, which would preclude obtaining informed consent or adherence to protocol.
- Geographic inaccessibility for follow-up.
- Inability to understand or unable to provide written informed consent.
- Inability to be registered on study within 12 weeks of the last surgical procedure on the breast.
- Central testing for Ki67 \> 13.25% consistent with the luminal B subtype
Key Trial Info
Start Date :
July 1 2013
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
July 1 2027
Estimated Enrollment :
500 Patients enrolled
Trial Details
Trial ID
NCT01791829
Start Date
July 1 2013
End Date
July 1 2027
Last Update
August 3 2025
Active Locations (27)
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1
Tom Baker Cancer Centre
Calgary, Alberta, Canada, T2N 4N2
2
Abbotsford Centre
Abbotsford, British Columbia, Canada, V2S 0C2
3
BC Cancer Agency, Centre for the North
Prince George, British Columbia, Canada, V2M 7E9
4
BCCA - Vancouver Centre
Vancouver, British Columbia, Canada, V5Z 4E6