Evaluating Harms and Benefits of Endocrine Therapy in Patients ≥70 Years of Age With Lower Risk Breast Cancer
Recruiting · NCT04921137 · Interventional (participants receive a specific treatment) · Lead sponsor: Ottawa Hospital Research Institute
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
The current standard of care for stage 1 hormone receptor-positive (HR+) breast cancer consists of breast-conserving surgery followed by adjuvant radiotherapy (RT) and endocrine therapy (ET) for at least 5 years. The benefit of adjuvant ET for older patients is mitigated because of their increase risk of death from other causes and shorter time horizon to live. Clinical and pathological factors such as low-intermediate grade, tumor size ≤2 cm, and older age have been used in a few studies to identify patients with a lower risk of recurrence that might benefit from adjuvant therapy de-escalation, i.e. omission of RT or ET. Since there is no dedicated randomized clinical trial (RCT) conducted to evaluate the omission of ET, there is clinical equipoise as to whether we can omit adjuvant ET in older patients with lower-risk early-stage breast cancer. Therefore, we propose a randomised, multicentre trial evaluating harms and benefits of endocrine therapy in patients ≥70 years of age with lower risk breast cancer.
Who can take part
Inclusion criteria
- New invasive estrogen and/or progesterone receptor-positive (ER+ and/or PR+), HER2-negative (HER2-) invasive breast carcinoma diagnosis as per ASCO-CAP guidelines
- The primary tumour characteristics are either: Grade 1 and ≤3 cm on microscope exam, OR Grade 2 and ≤2 cm on microscope exam, OR Grade 3 and ≤1 cm on microscope exam
- Treated with standard loco-regional therapy: breast conserving surgery followed by adjuvant radiotherapy OR total mastectomy
- Axillary node-negative (cN0 or pN0)
- Able to provide oral consent and complete questionnaires in French or English as per study protocol
Exclusion criteria
- Metastatic cancer
Where it is running
8 locations listed.
- Cross Cancer Institute - Edmonton, Alberta, Canada
- Waterloo Regional Health Network - Kitchener, Ontario, Canada
- London Health Sciences Centre - London, Ontario, Canada
- Oak Valley Health - Markham, Ontario, Canada
- The Ottawa Hospital - Ottawa, Ontario, Canada
- Thunder Bay Regional Health Sciences Centre - Thunder Bay, Ontario, Canada
- Allan Blair Cancer Centre - Regina, Saskatchewan, Canada
- Saskatoon Cancer Centre - Saskatoon, Saskatchewan, Canada