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Evaluating Harms and Benefits of Endocrine Therapy in Patients โ‰ฅ70 Years of Age With Lower Risk Breast Cancer

RecruitingPhase 4Ages 70 Years - anyAllOttawa Hospital Research Institute
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In plain words

What the trial is, and whether it could suit you

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 โ‰ค2 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, multi

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
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 โ‰ค3 cm on microscope exam, OR Grade 2 and โ‰ค2 cm on microscope exam, OR Grade 3 and โ‰ค1 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
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What it tests

  • No endocrine therapy
  • Endocrine therapy
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Where

8 sites
Cross Cancer Institute
Edmonton, Canada
Waterloo Regional Health Network
Kitchener, Canada
London Health Sciences Centre
London, Canada
Oak Valley Health
Markham, Canada
The Ottawa Hospital
Ottawa, Canada
Thunder Bay Regional Health Sciences Centre
Thunder Bay, Canada
Allan Blair Cancer Centre
Regina, Canada
Saskatoon Cancer Centre
Saskatoon, Canada
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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