NCT07245316
Not yet recruiting
Not Applicable
Avoiding Surgery in Estrogen Receptor Positive Atypical Ductal Hyperplasia and In-situ Carcinoma Treated With Endocrine Treatment Trial
Jeong Eon Lee1 site in 1 country340 target enrollmentStarted: December 1, 2025Last updated:
Overview
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- Jeong Eon Lee
- Enrollment
- 340
- Locations
- 1
- Primary Endpoint
- 5 year ipsilateral breast cancer incidence rate
Overview
Brief Summary
This study aims to evaluate the 5-year invasive ipsilateral breast cancer incidence rate in patients with hormone-receptor positive, HER-2 negative atypical ductal hyperplasia or in-situ carcimona who omitted surgery and received endocrine therapy.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 35 Years to — (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
5 year ipsilateral breast cancer incidence rate
Time Frame: 5 years after the last patient enrollment
This study aims to evaluate the 5-year invasive ipsilateral breast cancer incidence rate in patients with hormone-receptor positive, HER-2 negative atypical ductal hyperplasia or in-situ carcimona who omitted surgery and received endocrine therapy.
Secondary Outcomes
- Adjuvant chemotherapy rate(5 years after the last patient enrollment)
- invasive CBC rate(5 years after the last patient enrollment)
- OS(5 years after the last patient enrollment)
- BCSS(5 years after the last patient enrollment)
- Change in breast cancer-specific quality of life assessed by EORTC QLQ-BR23(At baseline, at 2 years, and at 5 years after the last patient enrollment)
- Change in health-related quality of life assessed by EORTC QLQ-C30(At baseline, at 2 years, and at 5 years after the last patient enrollment)
Investigators
Jeong Eon Lee
Professor, Department of Surgery
Samsung Medical Center
Study Sites (1)
Loading locations...
Similar Trials
Completed
Not Applicable
Epidemiology Study in Postmenopausal Women With Estrogen Receptor Positive Breast CancerHormon Receptor Positive Breast CancerNCT01208779AstraZeneca90
Completed
Not Applicable
Observational Study to Evaluate Mechanisms of Aromatase Inhibitor Associated Musculoskeletal SymptomsBreast CancerArthralgiaNCT02118636Lynn Henry75
Active, not recruiting
Phase 2
A Study to See Whether Estrogen Can Slow the Growth of Some ER Positive Breast CancersEstrogen Receptor Positive Breast CancerNCT02238808AHS Cancer Control Alberta19
Terminated
Not Applicable
Study to Determine the Utility of FES-PET and FDG-PET in the Prediction of Response to Hormone Therapy in Women With Estrogen Positive Metastatic Breast CancerMetastatic Breast CancerNCT00358098AHS Cancer Control Alberta51
Completed
Phase 2
Estradiol Levels in Patients Treated With EstringEstrogen Levels Among Breast Cancer PatientsNCT01923298University of Arizona14