Clinical trial · Observational
Prospective Feasibility Study Applying the ACOSOG Z0011 Criteria to Chinese Patients
A Prospective Feasibility Study Applying the ACOSOG Z0011 Criteria to Chinese Patients With Early Breast Cancer Undergoing Breast-conserving Surgery
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
In patients undergoing breast-conserving surgery and having positive sentinel lymph nodes (SLNs), the ACOSOG Z0011 trial showed equivalent overall survival(OS) and disease-free survival(DFS) outcomes for patients receiving SLN dissection (SLND) alone and those receiving axillary lymph node dissection (ALND). We conducted a prospective single-arm study to confirm the applicability of the Z0011 criteria to Chinese patients with breast cancer.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
| Local Recurrence of Malignant Tumor of Breast | Breast Neoplasm | PROBABILISTIC | 0.70 |
| Sentinel Lymph Node | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| no further ALND arm | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- ACOSOG Z0011 no further ALND arm
- description
- patients meeting the criteria for ACOSOG Z0011 trial inclusion：histologically confirmed invasive breast cancer;clinical T1/T2;breast conserving surgery；1 or 2 positive sentinel lymph nodes; Whole-breast RT planned; no preoperative chemotherapy
- interventionNames
- Procedure: no further ALND arm
Primary outcomes (1)
- measure
- overall survival
- timeFrame
- 5 years
- description
- the time from surgery until death from any cause
Secondary outcomes (2)
- measure
- disease-free survival
- timeFrame
- 5 years
- description
- the time from surgery to death or first documented recurrence of breast cancer
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * histologically confirmed invasive breast cancer T1 or T2 tumor 1 or 2 positive sentinel lymph nodes breast-conserving surgery whole-breast RT planned Exclusion Criteria: * preoperative therapy 3 or more positive sentinel lymph nodes patients undergoing additional mastectomy due to positive surgical margins
References
Publications (1)
- RESULTPeng Y, Liu M, Li X, Tong F, Cao Y, Liu P, Zhou B, Liu H, Cheng L, Guo J, Xie F, Yang H, Wang S, Wang C, Chen Y, Wang S. Application of the ACOSOG Z0011 criteria to Chinese patients with breast cancer: a prospective study. World J Surg Oncol. 2021 Apr 20;19(1):128. doi: 10.1186/s12957-021-02242-1. PMID 33879180