Not yet recruiting NCT07245316
Avoiding Surgery in Estrogen Receptor Positive Atypical Ductal Hyperplasia and In-situ Carcinoma Treated With Endocrine Treatment Trial
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Avoiding surgery.
- Who it may be relevant to
- Registry conditions: Ductal Carcinoma in Situ of the Breast. Basic parameters: from 35 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- South Korea
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Interventions
- Procedure Avoiding surgery
Avoiding surgery in hormone-receptor positive atypical ductal hyperplasia and in-situ carcinoma treated with endocrine treatment
Primary outcome measures
- 5 year ipsilateral breast cancer incidence rate [Time frame: 5 years after the last patient enrollment]
Secondary outcome measures (6)
- Adjuvant chemotherapy rate [Time frame: 5 years after the last patient enrollment]
- invasive CBC rate [Time frame: 5 years after the last patient enrollment]
- OS [Time frame: 5 years after the last patient enrollment]
- BCSS [Time frame: 5 years after the last patient enrollment]
- Change in health-related quality of life assessed by EORTC QLQ-C30 [Time frame: At baseline, at 2 years, and at 5 years after the last patient enrollment]
- Change in breast cancer-specific quality of life assessed by EORTC QLQ-BR23 [Time frame: At baseline, at 2 years, and at 5 years after the last patient enrollment]
Eligibility criteria
1\. 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.
- Provided written informed consent to participate in the study.
2\. 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.
- Concomitant diagnosis of pleomorphic LCIS.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
South Korea · 1 center
- Samsung Medical Center — Seoul
Identifiers
NCT: NCT07245316 · SMC 2025-02-036