Exemption of SLNB After Neoadjuvant Therapy for Triple-negative and Her2-positive Breast Cancer (NCT07498400) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Exemption of SLNB After Neoadjuvant Therapy for Triple-negative and Her2-positive Breast Cancer
China216 participantsStarted 2026-01-01
Plain-language 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. 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.
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.
Who can participate
Age range
18 Years – 70 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. 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;
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
. 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.
Exclusion criteria
. 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:
. 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.