Track this trial free. DataLookout checks ClinicalTrials.gov daily and emails you which fields changed on NCT04921137 (status, enrollment, completion dates, endpoints, sites) when this record is updated. Free accounts track up to 5 trials.

Track this trial

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

StatusRecruiting
PhasePhase 4
Started2021-08-19
View on ClinicalTrials.gov ↗

Amendment history

2026-05-25
Active, Not Recruiting→Recruiting Study Status, Oversight, Study Design, Outcome Measures, Eligibility, Contacts/Locations v6
Trial statusActive, Not Recruiting→Recruiting
Primary completion date2029-02→2036-05
Completion date2029-02→2036-05
Enrollment target109→500
Study sites7→8
Eligibility criteria+2 characters
[...] The primary tumour characteristics are either: Grade 1 and ≤53 cm on microscope exam, OR Grade 2 and ≤32 cm on microscope exam, OR Grade 3 and ≤1 cm on microscope e [...] llowed by adjuvant radiotherapy OR total mastectomy Axillary lymph node-negative (N0cN0 or pN0) Able to provide oral consent and complete questionnaires i [...]
Secondary endpoints4 to 14 entries
SignificantOverall adversesurvival Invasive eventsdisease free survival EndocrineMetastatic therapydisease relatedfree toxicitysurvival Health-related quality of life: scoresFACT-B plus ES RateHot flashes Joint pain Health-related quality of treatmentlife: discontinuationFACT-G Health-related quality of life: EQ-5D-5L Breast Cancer Specific Survival Adverse events of interest Change in geriatric domains Adherence with prescribed endocrine therapy Quality-adjusted life years (QALY) Beliefs about Medicine Questionnaire - adjuvant endocrine therapy (BMQ-AET)
Primary endpoints3 to 1 entries
90%Hierarchical treatmentcomposite allocationendpoint rate Accrual(OS, ofiDFS, 100MDFS, participants across 8 centres within 2 years Participation rate of at least 60%QoL)
2025-11-19
Study Status v5
Re-verified, no change to tracked fields
2025-04-22
Study Status, Contacts/Locations, References v4
Primary completion date2024-09→2029-02
Completion date2025-09→2029-02
Study sites1→7
2024-07-23
Recruiting→Active, Not Recruiting Study Status, Study Design, Contacts/Locations v3
Trial statusRecruiting→Active, Not Recruiting
Primary completion date2023-09→2024-09
Completion date2024-09→2025-09
Enrollment targetestimated 100→confirmed 109
Study sitesdetails revised at 1 of 1 site
2022-09-13
Study Status v2
Re-verified, no change to tracked fields
2021-09-03
Not Yet Recruiting→Recruiting Study Status, Contacts/Locations v1
Trial statusNot Yet Recruiting→Recruiting
Start dateestimated 2021-09→confirmed 2021-08-19
Study sites0→1
2021-06-04
Original filing
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.
Trial Details
NCT Number NCT04921137
Lead Sponsor Ottawa Hospital Research Institute
Conditions Breast Cancer
Enrollment 500 participants
Start Date 2021-08-19
Primary Completion 2036-05 (estimated)
Study Completion 2036-05 (estimated)
Updated on ClinicalTrials.gov 2026-05-28