Avoiding Surgery in Estrogen Receptor Positive Atypical Ductal Hyperplasia and In-situ Carcinoma … (NCT07245316) | Clinical Trial Compass
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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 range
35 Years
Sex
FEMALE
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
5 year ipsilateral breast cancer incidence rate
Timeframe: 5 years after the last patient enrollment
. 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.
. Evidence of axillary lymph node metastasis.
. Carriers of BRCA1/2 mutations.
. Male patients.
. History of diagnosis or treatment for breast cancer.
. Presence or history of other malignancies besides breast cancer.