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Breast Cancer (Triple Negative Breast Cancer (TNBC))NCT07498400

Exemption of SLNB After Neoadjuvant Therapy for Triple-negative and Her2-positive Breast Cancer

A study testing Exemption of SLNB in people with Breast Cancer (Triple Negative Breast Cancer (TNBC)) and Breast Cancer, run by Xijing Hospital at 1 site in China.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

The neoadjuvant system therapy (NAST) can significantly increase the pathological complete response (pCR) rate for patients with triple-negative (TNBC) and HER2-positive breast cancer. Read more about this study

Who is it for?
Ages 18 to 70 years, women only
What is being tested?
Exemption of SLNB
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
216 participants
Where
1 siteChina
Study dates
1 Jan 2026to 1 Mar 2031
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 18 to 70 years
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Female, aged 18 to 70 years;
  • Histologically diagnosed with invasive breast cancer, clinical stage T1-T2 (tumor maximum diameter ≤ 5 cm), clinical assessment as cN0 (physical examination + at least two negative imaging tests, including axillary ultrasound, and MRI or PET CT when necessary);
  • Immunohistochemistry or ISH confirmed as HER2 positive (IHC 3+ or ISH positive) or triple-negative (ER, PR, HER2);
  • Completed a standardized neoadjuvant chemotherapy regimen (including HER2-targeted or immune checkpoint inhibitors), and was assessed as clinical complete response (CCR) before surgery;
  • No residual masses on physical examination;
  • Imaging (MMG/US/MRI) shows the tumor ≤ 2 cm or complete disappearance;
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  • Preoperative or intraoperative biopsy (when necessary) confirmed no residual invasive cancer.
  • ECOG 0-1, and expected to be able to receive whole breast radiotherapy after breast-conserving surgery.
  • Voluntarily signed a written informed consent.

Who cannot join

  • Tumor-related symptoms and treatment 1) Patients with metastatic breast cancer or bilateral breast cancer; 2) Patients with inflammatory breast cancer; 3) Patients with multiple lesion sites;
  • Comorbid diseases/medical history 1) Previously had other malignant tumors and received any systemic anti-tumor treatment or local treatment (including surgery and radiotherapy), excluding cured cervical carcinoma in situ, basal cell carcinoma or squamous cell carcinoma and other malignant tumors; 2) Within 4 weeks before enrollment, had undergone major surgeries unrelated to breast cancer or the patient had not fully recovered from such surgeries (biopsy for diagnostic purposes and peripheral venous puncture for central venous catheter insertion [PICC] are allowed); 3) Human immunodeficiency virus (HIV) infection or known acquired immune deficiency syndrome (AIDS); active hepatitis (hepatitis B, defined as HBV-DNA ≥ 500 IU/ml; hepatitis C, positive hepatitis C antibody and HCV-RNA above the detection limit of the analytical method) or co-infection with hepatitis B and hepatitis C; autoimmune hepatitis; 4) Previously or preparing to undergo allogeneic bone marrow transplantation or solid organ transplantation; 6) Severe heart disease or discomfort, including but not limited to the following diseases:
  • History of diagnosed heart failure or systolic dysfunction (LVEF < 50%)
  • High-risk uncontrolled arrhythmias, such as atrial tachycardia, resting heart rate > 100 bpm, significant ventricular arrhythmias (such as ventricular tachycardia) or higher-level atrioventricular conduction block (i.e. Mobitz II second-degree atrioventricular conduction block or third-degree atrioventricular conduction block)
  • Angina pectoris requiring anti-anginal drug treatment
  • Clinically significant heart valve disease
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  • ECG showing transmural myocardial infarction
  • Poorly controlled hypertension (systolic pressure > 180 mmHg and/or diastolic pressure > 100 mmHg)
  • Pregnant or lactating female patients, female patients with reproductive capacity and positive baseline pregnancy test results or fertile women patients who are unwilling to take effective contraceptive measures throughout the trial period.
  • Previously had a clear history of neurological or mental disorders, including epilepsy or dementia, and the subjects were known to have a history of substance abuse of psychotropic drugs, alcoholism or drug abuse; Other conditions that the investigator considers make the patient unsuitable to participate in this study.

Trial locations and contacts

1 site in 1 country.

China1 site

  • Xijing Hospital

    Xi'an

Other trials in China

About this study

Official title: A Multicenter, Randomized Controlled Study on the Exemption of Sentinel Lymph Node Biopsy After Neoadjuvant Therapy for Triple-negative and Her2-positive Breast Cancer

The neoadjuvant system therapy (NAST) can significantly increase the pathological complete response (pCR) rate for patients with triple-negative (TNBC) and HER2-positive breast cancer. Some patients can achieve complete disappearance of the tumor or only residual tumors ≤ 2 cm in preoperative imaging examinations (mammography, ultrasound or MRI), which is defined as clinical complete response (cCR).

The traditional surgical approach still requires sentinel lymph node biopsy (SLNB) even for cCR cases to rule out axillary metastasis. However, the association of SLNB with complications such as lymphedema, pain, and limited shoulder joint function has been confirmed in multiple retrospective cohorts, significantly reducing the quality of life of patients.

Read more

Current guidelines (such as ASCO 2025, SOUND, INSEMA) propose that SLNB can be omitted in low-risk populations, but these recommendations are mainly based on postoperative pathological information (pCR) or overall survival (OS)/progression-free survival (DFS), and lack high-level evidence for the direct assessment of axillary lymph node recurrence rate (AR).

Therefore, there is an urgent need to conduct prospective, randomized controlled trials to clarify whether omitting SLNB will lead to an increase in axillary recurrence in T1-2 N0 triple-negative or HER2-positive breast cancer patients who achieve cCR after neoadjuvant treatment. The results of this study will provide evidence-based support for surgical de-radication, potentially significantly reducing surgical-related complications, saving medical resources, and improving the quality of life of patients.

Being tested
Exemption of SLNB
Medical subject headings
Breast Neoplasms, Triple Negative Breast Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Exemption of SLNBProcedure or surgery

    Breast-conserving surgery (or mastectomy) without sentinel lymph node biopsy (SLNB). Postoperatively, conventional radiotherapy (for breast-conserving therapy), endocrine (HR+) immunotherapy (for triple-negative cases), or HER2-targeted (HER2+) treatment is received.

Study groups in NCT07498400
Study groupRoleWhat they receive
Exemption of SLNBExperimentalNot described
Receives: Procedure: Exemption of SLNB
Not Exemption of SLNBNo interventionNot described

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Efficacy Measurement

    3-year AR (axillary recurrence rate): Axillary lymph node metastasis (stage I - III) confirmed by imaging (US/MRI/CT) or pathology within 3 years after surgery; not included in distant metastasis

    Measured: 3 years

Secondary outcomes (5)

  1. DFS

    The time from the subject's enrollment to the first occurrence of a recurrent disease. Recurrent diseases include recurrence on the same side or on the opposite side of the breast, local or regional recurrence, distant recurrence, and any death caused by

    Measured: 3 years

  2. OS

    The time from enrollment to death due to any cause.

    Measured: 3 years

  3. Complications

    Surgery-related complications (lymphedema, pain, limited shoulder function)

    Measured: 3 years

  4. QLQ C30

    Changes in European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ C30). The assessment form consists of 30 items. Each item is scored from 1 to 4 points. The higher the score, the more severe the symptoms and the poorer the quality of life.

    Measured: 3 years

  5. ICER

    Cost-effectiveness (ICER)

    Measured: 3 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Mar 2026
  2. Study start1 Jan 2026
  3. Primary completion31 Dec 2030 (estimated)
  4. Study completion1 Mar 2031 (estimated)

Resources

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
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
216 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07498400
Sponsor's protocol ID
XJLL-KY-20262002
Status last verified
Mar 2026
First submitted
16 Mar 2026
Last updated
27 Mar 2026
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Exemption of SLNB in people with Breast Cancer (Triple Negative Breast Cancer (TNBC)) and Breast Cancer, run by Xijing Hospital at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 10 exclusion criteria. 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: under way, not looking for participants, as of the sponsor's last update on 27 Mar 2026. 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 China. 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?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Efficacy Measurement (time frame: 3 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07498400.

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 27 Mar 2026.

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