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

Recruiting now · Phase 4

Conditions studied: Breast Cancer

In brief

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.

Key facts

Study ID

NCT04921137

Run by

Ottawa Hospital Research Institute

People needed

500

Starts

2021-08-19

Expected to finish

2036-05-01

Last updated by the study team

2026-05-28

Who can join

Age: 70 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• Metastatic cancer

Where it is running

• The Ottawa Hospital — Ottawa, Ontario, Canada (enrolling)
• Waterloo Regional Health Network — Kitchener, Ontario, Canada
• London Health Sciences Centre — London, Ontario, Canada
• Oak Valley Health — Markham, Ontario, Canada
• Thunder Bay Regional Health Sciences Centre — Thunder Bay, Ontario, Canada
• Allan Blair Cancer Centre — Regina, Saskatchewan, Canada
• Cross Cancer Institute — Edmonton, Alberta, Canada
• Saskatoon Cancer Centre — Saskatoon, Saskatchewan, Canada

Full record on ClinicalTrials.gov

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