Avoiding axillary surgery in certain breast cancer patients after chemotherapy
Selective Omission of Axillary Surgery in Distinct Responders With Triple-negative and HER2-positive Breast Cancer After NACT
This study is testing if certain breast cancer patients who respond well to chemotherapy can skip surgery on their underarm lymph nodes to avoid extra pain and recovery time.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 136 (estimated) |
| Ages | 18 Years to 70 Years |
| Sex | Female |
| Sponsor | Peking University Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Beijing, Beijing Municipality) |
| Trial ID | NCT05314114 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are women aged 18 and older with unicentric, biopsy-confirmed triple-negative or HER2-positive breast cancer who are initially cN0 and have shown a positive response to NACT.
Not a fit: Patients with a history of previous malignancy, those with confirmed lymph node involvement (N1), or those who are pregnant or lactating will not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly reduce the physical and emotional burden of surgery for patients with specific types of breast cancer.
How similar studies have performed: Other studies have suggested that omitting axillary surgery in similar patient populations may be feasible, indicating a potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Beijing, Beijing Municipality
- Peking University Cancer Hospital — Beijing, Beijing Municipality, China (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.