Avoiding axillary surgery in certain breast cancer patients after chemotherapy

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial investigates the potential to omit axillary surgery in patients with triple-negative and HER2-positive breast cancer who have undergone neoadjuvant chemotherapy (NACT). The study aims to determine if patients who achieve a pathological complete response (pCR) in the breast after NACT can safely avoid sentinel lymph node biopsy (SLNB) and subsequent axillary dissection, which are associated with increased post-operative disability. By focusing on patients with initial clinical node-negative (cN0) status, the trial seeks to reduce physical and emotional distress while maintaining effective cancer treatment outcomes.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Written informed consent
* Core biopsy confirmed unicentric primary invasive triple-negative or HER2-positive breast cancer. Multifocal or multicentric tumors allowed only if breast-conserving surgery is deemed feasible.
* At least 18 years of age
* Initial tumor stage cT1c-T3N0M0 prior to NACT. cN0 stage established by clinical examination and ultrasonography
* In cases with suspicious lymph node, a negative core biopsy or fine needle aspiration (FNA) biopsy of the sonographically suspected lymph node is required
* Standard NACT with evident radiologic response
* Planned breast-conserving surgery with postoperative external whole-breast irradiation

Exclusion Criteria:

* History of previous malignancy
* Histologically proven N1 patients, patients with distant metastasis (M1)
* Pregnant or lactating patients
* Inflammatory breast cancer
* Radiologically non-responsive after NACT
* Mastectomy planned after NACT
* planned intraoperative radiotherapy (e.g. Intrabeam) or postoperative partial breast irradiation (e.g. multicatheter technique) alone; both procedures are allowed as boost techniques
* Written informed consent not obtained

Where it's running

• Peking University Cancer Hospital
  Beijing, Beijing Municipality, China Recruiting

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.