REthinking Clinical Trials



Risks and benefits of hormonal therapy in patients with low risk breast cancer who are 70 years of age and older.

Principal Investigator(s): Dr. Marie-France Savard NCT04921137
This study is for patients with low risk breast cancer who are 70 years of age or older. The standard of care for this population would be breast-conserving surgery followed by radiotherapy, or mastectomy, and hormonal therapy. Hormonal therapy is a pill to take every day for 5 years. The side effects of hormonal therapy are significant and include: fatigue, hot flashes, joint pain/body aches, bone loss or osteoporosis, bone fracture, blood clots, cardiovascular disease, cognitive impairment and endometrial cancer. For older patients, it is not clear if the benefits of hormonal therapy outweigh the risks because older patients have an increased number of other diseases or health conditions which makes them more at risk to side effects that affect their quality of life and lifestyle. The goal of this proposed study is to randomize patients to radiotherapy plus hormonal therapy vs radiotherapy alone and evaluate the risks and benefits of hormonal therapy in this older patient population.

Sites: Allan Blair Cancer Centre (Regina) Grand River Hospital (Kitchener Waterloo) London Health Sciences Centre Markham Stouffville Hospital Saskatoon Cancer Centre The Ottawa Hospital Thunder Bay Health Research Institute

Tags: Early stage Breast Cancer


Systematic Review:

  • De-escalating adjuvant therapies in older patients with lower risk estrogen receptor-positive breast cancer treated with breast-conserving surgery: A systematic review and meta-analysis. Savard et al. PMID: 34242928


  • Management strategies for older patients with low risk early stage breast cancer: a physician survey. Alzahrani et al. 2021. PMID: 35049675
  • Experiences and Perceptions of Older Adults with Lower-risk Hormone Receptor-positive Breast Cancer about Adjuvant Radiotherapy and Endocrine Therapy: A Patient Survey. Savard et al. PMID: 34940075