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

Jeong Eon Lee

Status: Not yet enrolling

Conditions: Ductal Carcinoma in Situ of the Breast

Treatments: Procedure: Avoiding surgery

Study type: Interventional

Funder types: Other

Identifiers

NCT07245316

SMC 2025-02-036

Details and patient eligibility

About

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.

Enrollment: 340 estimated patients

Sex: Female

Ages: 35+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

1. Inclusion criteria:

1. Female patients aged ≥35 years.
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.

2. Exclusion criteria:

1. Pregnant patients.
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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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340 participants in 1 patient group

Active monitoring arm

Experimental group

Description:

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

Treatment:

Procedure: Avoiding surgery