Avoiding Surgery in Estrogen Receptor Positive Atypical Ductal Hyperplasia and In-situ Carcinoma … (NCT07245316) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Avoiding Surgery in Estrogen Receptor Positive Atypical Ductal Hyperplasia and In-situ Carcinoma Treated With Endocrine Treatment Trial
South Korea340 participantsStarted 2025-12-01
Plain-language 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.
Who can participate
Age range35 Years
SexFEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. Female patients aged ≥35 years.
✓. 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.
✓. 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.
✓. All low- and intermediate-grade nuclear grades included; for high-grade lesions, only patients with a Ki-67 index ≤20% are eligible.
✓. Lesion not definitely palpable on physical examination at diagnosis.
✓. No prior breast surgery for ipsilateral or contralateral breast cancer, and no synchronous contralateral breast cancer.
✓. Not diagnosed with pregnancy-associated breast cancer or breast cancer detected during lactation.
✓. Negative serum or urine β-hCG prior to enrollment.
Exclusion criteria
✕. Pregnant patients.
✕. Patients with clinically significant psychiatric disorders (e.g., major depressive disorder) or those currently receiving psychiatric or antipsychotic medications.
✕. Concomitant diagnosis of invasive breast cancer.
What they're measuring
1
5 year ipsilateral breast cancer incidence rate
Timeframe: 5 years after the last patient enrollment