RecruitingPhase 4NCT04921137

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

A Randomised, Multicentre Trial Evaluating Harms and Benefits of Endocrine Therapy in Patients ≥70 Years of Age With Lower Risk Breast Cancer (REaCT-70)


Sponsor

Ottawa Hospital Research Institute

Enrollment

500 participants

Start Date

Aug 19, 2021

Study Type

INTERVENTIONAL

Conditions

Summary

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.


Eligibility

Min Age: 70 Years

Inclusion Criteria5

  • 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 Criteria1

  • Metastatic cancer

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Interventions

OTHERNo endocrine therapy

No endocrine therapy given

OTHEREndocrine therapy

Endocrine therapy given for at least 5 years


Locations(8)

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

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NCT04921137


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