Evaluating Harms and Benefits of Endocrine Therapy in Patients ≥70 Years of Age With Lower Risk Breast Cancer

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-escalatio

Trial Details

NCT ID
NCT04921137
Phase
PHASE4
Sponsor
Ottawa Hospital Research Institute
Status
RECRUITING
Cancer Type
ER/PR Positive (Hormone Receptor Positive) Breast Cancer
Interventions
  • No endocrine therapy
  • Endocrine therapy
Locations (sample)
  • Edmonton, Alberta, Canada|53.55014,-113.46871
  • Kitchener, Ontario, Canada|43.42537,-80.5112
  • London, Ontario, Canada|42.98339,-81.23304
  • Markham, Ontario, Canada|43.86682,-79.2663
  • Ottawa, Ontario, Canada|45.41117,-75.69812

Key Eligibility Criteria

  • New invasive estrogen and/or progesterone receptor-positive (ER+ and/or PR+), HER2-negative (HER2-) invasive breast carcinoma diagnosis as per ASCO…
  • 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 …
  • Treated with standard loco-regional therapy: breast conserving surgery followed by adjuvant radiotherapy OR total mastectomy
  • Axillary node-negative (cN0 or pN0)

For full eligibility, visit ClinicalTrials.gov.

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