Avoiding Surgery in Estrogen Receptor Positive Atypical Ductal Hyperplasia and In-situ Carcinoma Treated With Endocrine Treatment Trial
NCT ID: NCT07245316
Last Updated: 2025-11-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
NOT_YET_RECRUITING
NA
340 participants
INTERVENTIONAL
2025-12-01
2032-12-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Safety and Quality of Life of Three Treatment Strategies for Low-Risk Papillary Thyroid Microcarcinoma
NCT07249125
Use of a New Stapling Device in General Thoracic Surgery
NCT05143541
A Retrospective Analysis of Statin Use and Outcome After Thoracic Cancer Surgery
NCT01169051
Compare the Aesthetic Effect of Different Thyroidectomies
NCT03239769
Comparison of Voice Results at 5 Years of Treatment of Glottic Squamous Cell Carcinoma T1 by Surgery Versus Radiotherapy
NCT04447456
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Active monitoring arm
Active monitoring with endocrine therapy in hormone-receptor positive, HER-2 negative DCIS, LCIS, ADH without surgery
Avoiding surgery
Avoiding surgery in hormone-receptor positive atypical ductal hyperplasia and in-situ carcinoma treated with endocrine treatment
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Avoiding surgery
Avoiding surgery in hormone-receptor positive atypical ductal hyperplasia and in-situ carcinoma treated with endocrine treatment
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
2. Diagnosed with atypical ductal hyperplasia (ADH), ductal carcinoma in situ (DCIS), or lobular carcinoma in situ (LCIS) on core-needle biopsy, vacuum-assisted biopsy, or excisional biopsy.
3. Immunohistochemistry (IHC) performed on biopsy specimens confirming estrogen receptor (ER), progesterone receptor (PR), and HER2 status; eligible only if the ER Allred total score is ≥7 and HER2 status is negative.
4. All low- and intermediate-grade nuclear grades included; for high-grade lesions, only patients with a Ki-67 index ≤20% are eligible.
5. Lesion not definitely palpable on physical examination at diagnosis.
6. No prior breast surgery for ipsilateral or contralateral breast cancer, and no synchronous contralateral breast cancer.
7. Not diagnosed with pregnancy-associated breast cancer or breast cancer detected during lactation.
8. Negative serum or urine β-hCG prior to enrollment.
9. Provided written informed consent to participate in the study.
Exclusion Criteria
2. Patients with clinically significant psychiatric disorders (e.g., major depressive disorder) or those currently receiving psychiatric or antipsychotic medications.
3. Concomitant diagnosis of invasive breast cancer.
4. Evidence of axillary lymph node metastasis.
5. Carriers of BRCA1/2 mutations.
6. Male patients.
7. History of diagnosis or treatment for breast cancer.
8. Presence or history of other malignancies besides breast cancer.
9. Concomitant diagnosis of pleomorphic LCIS.
35 Years
FEMALE
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Jeong Eon Lee
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Jeong Eon Lee
Professor, Department of Surgery
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Jeong Eon Lee, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Samsung Medical Center
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Samsung Medical Center
Seoul, , South Korea
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
SMC 2025-02-036
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.