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

  • STATUS
    Recruiting
  • End date
    Sep 20, 2024
  • participants needed
    100
  • sponsor
    Ottawa Hospital Research Institute
Updated on 7 October 2022
Investigator
Lisa Vandermeer
Primary Contact
The Ottawa Hospital (4.0 mi away) Contact
estrogen
carcinoma
endocrine therapy
progesterone
hormone therapy
HER2
progesterone receptor
erbb2
breast carcinoma
mastectomy
breast cancer staging
breast-conserving surgery
early-stage breast cancer

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.

Description

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. This population is also more likely to have additional comorbidities which can lead to higher treatment-related adverse events impacting quality of life and precipitating functional decline. 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. The body of evidence from small prospective studies, mathematical modelling study and retrospective analyses would suggest that the omission of ET in older patients with favourable HR+ breast cancer who had optimal local therapy (i.e. breast conserving surgery followed by adjuvant radiotherapy) does not compromise locoregional and survival outcomes. 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.

Details
Condition Breast Cancer, breast carcinoma, cancer, breast, Breast Cancer Diagnosis
Treatment Endocrine Therapy, No endocrine therapy
Clinical Study IdentifierNCT04921137
SponsorOttawa Hospital Research Institute
Last Modified on7 October 2022

Eligibility

Yes No Not Sure

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 5 cm on microscope exam, OR Grade 2 and 3 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 lymph node-negative (N0)
Able to provide oral consent and complete questionnaires in French or English as per study protocol

Exclusion Criteria

Metastatic cancer
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