Avoiding Surgery in Estrogen Receptor Positive Atypical Ductal Hyperplasia and In-situ Carcinoma Treated With Endocrine Treatment Trial

NCT07245316 | Not Yet Recruiting

• 1 other identifier: SMC 2025-02-036
• Study Type: interventional
• Target: 340
• Locations: 1 country
• Sites: 1

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.

Conditions

Ductal Carcinoma in Situ of the Breast

Keywords

ASAIN

Outcome Measures

Primary Outcomes (1)

• 5 year ipsilateral breast cancer incidence rate

  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.

  5 years after the last patient enrollment

Secondary Outcomes (6)

• 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 health-related quality of life assessed by EORTC QLQ-C30

  At baseline, at 2 years, and at 5 years after the last patient enrollment

Other Outcomes (6)

• Prognostic differences in invasive breast cancer progression according to age and type of endocrine therapy

  5 years after the last patient enrollment

• Adverse events associated with endocrine therapy and ovarian function suppression

  From initiation of endocrine therapy to treatment discontinuation or last follow-up (up to 5 years after enrollment)

• Direct medical cost of active monitoring compared with standard therapy

  5 years after the last patient enrollment

Study Arms (1)

Active monitoring arm

EXPERIMENTAL

Active monitoring with endocrine therapy in hormone-receptor positive, HER-2 negative DCIS, LCIS, ADH without surgery

Procedure: Avoiding surgery

Interventions

Avoiding surgery PROCEDURE

Avoiding surgery in hormone-receptor positive atypical ductal hyperplasia and in-situ carcinoma treated with endocrine treatment

Active monitoring arm

Eligibility Criteria

• Age: 35 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Jeong Eon Lee: lead

Study Sites (1)

Samsung Medical Center

Seoul, South Korea

Location

MeSH Terms

Conditions

Carcinoma, Intraductal, Noninfiltrating

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Breast Carcinoma In Situ; Carcinoma in Situ; Neoplasms, Ductal, Lobular, and Medullary

Study Officials

• Jeong Eon Lee, MD, PhD

  Samsung Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jeong Eon Lee, MD, PhD

CONTACT

+82-10-9933-0260; paojlus@hanmail.net

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor, Department of Surgery

Study Record Dates

• First Submitted: August 20, 2025
• First Posted: November 24, 2025
• Study Start: December 1, 2025
• Primary Completion (Estimated): December 31, 2032
• Study Completion (Estimated): December 31, 2032
• Last Updated: November 24, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)