Ductal Carcinoma in Situ of the BreastASAINNCT07245316
Avoiding Surgery in Estrogen Receptor Positive Atypical Ductal Hyperplasia and In-situ Carcinoma Treated With Endocrine Treatment Trial
A study testing Avoiding surgery in people with Ductal Carcinoma in Situ of the Breast, run by Jeong Eon Lee at 1 site in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Ages 35 years and older, women only
- Conditions the study is for
- Ductal Carcinoma in Situ of the Breast
- What is being tested?
- Avoiding surgery
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 340 participants
- Where
- 1 siteSouth Korea
- Study dates
- 1 Dec 2025to 31 Dec 2032
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 35 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
- 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.
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
South Korea1 site
Samsung Medical Center
Seoul
Jeong Eon Lee, MD, PhD, +82-10-9933-0260, paojlus@hanmail.net
About this study
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
- Being tested
- Avoiding surgery
- Keywords
- ASAIN
- Medical subject headings
- Carcinoma, Intraductal, Noninfiltrating
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Avoiding surgeryProcedure or surgery
Avoiding surgery in hormone-receptor positive atypical ductal hyperplasia and in-situ carcinoma treated with endocrine treatment
| Study group | Role | What they receive |
|---|---|---|
| Active monitoring arm | Experimental | Active monitoring with endocrine therapy in hormone-receptor positive, HER-2 negative DCIS, LCIS, ADH without surgery Receives: Procedure: Avoiding surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 5 years after the last patient enrollment
Secondary outcomes (6)
Adjuvant chemotherapy rate
5 year adjuvant chemotherapy rate
Measured: 5 years after the last patient enrollment
invasive CBC rate
5 year invasive contralateral breast cancer rate
Measured: 5 years after the last patient enrollment
OS
5 year overall survival
Measured: 5 years after the last patient enrollment
BCSS
5 year breast cancer specific survival
Measured: 5 years after the last patient enrollment
Change in health-related quality of life assessed by EORTC QLQ-C30
HRQoL will be evaluated using the EORTC QLQ-C30. Scores range from 0-100. Higher functional/global health scores indicate better QoL, while higher symptom scores indicate greater symptom burden.
Measured: 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
Breast cancer-specific QoL will be assessed using the EORTC QLQ-BR23. Scores range from 0-100. Higher functional scores indicate better QoL; higher symptom scores indicate worse symptom burden.
Measured: At baseline, at 2 years, and at 5 years after the last patient enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Nov 2025
- Study start1 Dec 2025 (estimated)
- Primary completion31 Dec 2032 (estimated)
- Study completion31 Dec 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ductal Carcinoma in Situ of the BreastStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 340 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jeong Eon Lee
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Jeong Eon Lee, Samsung Medical Center
- Investigators
- Jeong Eon Lee, MD, PhD, Principal investigator, Samsung Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07245316
- Sponsor's protocol ID
- SMC 2025-02-036
- Acronym
- ASAIN
- Status last verified
- Oct 2025
- First submitted
- 20 Aug 2025
- Last updated
- 24 Nov 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Avoiding Surgery in Estrogen Receptor Positive Atypical Ductal Hyperplasia and In-situ Carcinoma Treated With Endocrine Treatment Trial
- ClinicalTrials.gov ID
- NCT07245316
- Acronym / sponsor ID
- ASAIN / SMC 2025-02-036
- Conditions
- Ductal Carcinoma in Situ of the Breast
- Keywords
- ASAIN
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 340 participants (estimated)
- Lead sponsor
- Jeong Eon LeeUniversity, hospital or other
- Study start
- 1 Dec 2025 (estimated)
- Primary completion
- 31 Dec 2032 (estimated)
- Study completion
- 31 Dec 2032 (estimated)
- First posted
- 24 Nov 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Active monitoring arm | Experimental | Procedure: Avoiding surgeryActive monitoring with endocrine therapy in hormone-receptor positive, HER-2 negative DCIS, LCIS, ADH without surgery |
Who may qualify
- Ages
- 35 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Avoiding surgeryAvoiding surgery in hormone-receptor positive atypical ductal hyperplasia and in-situ carcinoma treated with endocrine treatment | Procedure or surgery | Active monitoring arm |
Primary outcome
5 year ipsilateral breast cancer incidence rate
Time frame: 5 years after the last patient enrollment
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.
6 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Nov 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Jeong Eon Lee, MD, PhD principal investigator
Samsung Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Avoiding surgery in people with Ductal Carcinoma in Situ of the Breast, run by Jeong Eon Lee at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 24 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jeong Eon Lee, MD, PhD (+82-10-9933-0260, paojlus@hanmail.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
5 year ipsilateral breast cancer incidence rate (time frame: 5 years after the last patient enrollment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Nov 2025.