Recruiting

Endocrine Therapy

Sponsor:

Ottawa Hospital Research Institute

Code:

NCT04921137

Conditions

Breast Cancer

Eligibility Criteria

Sex: All

Age: 70+

Healthy Volunteers: Not accepted

Interventions

No endocrine therapy

Endocrine therapy

Study Details

Brief 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.

Conditions

Breast Cancer

Study ID

NCT04921137

Start date

Aug 19, 2021

Status verified date

May, 2026

Completion date

May, 2036

Anticipated

Primary completion date

May, 2036

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 70+

Healthy Volunteers: Not accepted

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 ≤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 Criteria:

  • Metastatic cancer

Study Design

Enrollment

500 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Omission of endocrine therapy

Omission of endocrine therapy

active comparator: Administration of endocrine therapy for at least 5 years

Administration of endocrine therapy for at least 5 years

Interventions

No endocrine therapy

No endocrine therapy given

Endocrine therapy

Endocrine therapy given for at least 5 years

Primary outcome measure

  • Hierarchical composite endpoint (OS, iDFS, MDFS, QoL) [ Time Frame: 5 years ]

Central Contacts and Locations

Central contacts

Locations

The Ottawa Hospital

Recruiting

Ottawa, Ontario, Canada, K1H8L6

More Information

Sponsor

Ottawa Hospital Research Institute

Last update posted

May 28, 2026

Last verified

May, 2026

Keywords

  • Radiation therapy
  • Endocrine therapy
  • Older patients
  • Adjuvant therapy

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Ottawa Hospital Research Institute on 2026-05-28.