Trials / Recruiting
RecruitingNCT05939830
Omission of ALND in Breast Cancer Patients With Axillary pCR
Omission of Axillary Lymph Node Dissection in Breast Cancer Patients With Axillary Pathological Complete Response After Neoadjuvant Systemic Therapy
- Status
- Recruiting
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 92 (estimated)
- Sponsor
- The First Affiliated Hospital with Nanjing Medical University · Academic / Other
- Sex
- Female
- Age
- 18 Years – 70 Years
- Healthy volunteers
- Not accepted
Summary
This prospective, single-arm, phase II trial studies axillary lymph node dissection (ALND) to see if it can be safely omitted in breast cancer patients with axillary pathological complete response (pCR) after neoadjuvant systemic therapy (NST). Breast cancer patients with biopsy-proven positive axillary lymph nodes at initial diagnosis, and converted to negative after NST, which is confirmed by Stained region Lymph Node Biopsy(SrLNB), will be enrolled in the study. In other words, a total of 92 patients will be exempted from ALND after SrLNB, and afterwards complete regional node irradiation (RNI) including the axilla. They will also undergo adjuvant chemotherapy, targeted therapy, endocrinotherapy after surgery. These patients will be followed up in the next three years for local-regional recurrence and long-time survival outcome.
Conditions
- Axillary Lymph Node Dissection
- Pathological Complete Response
- Neoadjuvant Systemic Therapy
- Breast Cancer
- Axillary Lymph
Interventions
| Type | Name | Description |
|---|---|---|
| PROCEDURE | Stained region Lymph Node Biopsy (SrLNB) | Before NST, carbon nanoparticles suspension would be injected into the cortex of positive lymph nodes for staining under ultrasound guidance. Marked lymph nodes will be removed and biopsied after NST. |
| RADIATION | Regional lymph node radiotherapy (RNI) including the axilla | RNI including the axilla covers the supraclavicular region and entire axillary lymphatic drainage area (region I, II and III) ,and is at a dose of 50 Gy/25 times, with additional prophylactic irradiation of the internal breast lymphatic drainage area for eligible patients. |
Timeline
- Start date
- 2023-09-11
- Primary completion
- 2025-07-01
- Completion
- 2026-07-01
- First posted
- 2023-07-11
- Last updated
- 2024-12-30
Locations
1 site across 1 country: China
Source: ClinicalTrials.gov record NCT05939830. Inclusion in this directory is not an endorsement.