Prospective Feasibility Study Applying the ACOSOG Z0011 Criteria to Chinese Patients

NCT03606616 | Completed

• 1 other identifier: ACOSOGZ0011CH
• Study Type: observational
• Target: 142
• Locations: 1 country
• Sites: 1

Brief Summary

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

Breast Cancer; Sentinel Lymph Node; Local Recurrence of Malignant Tumor of Breast

Keywords

ACOSOG Z0011; Chinese breast cancer; sentinel lymph node; overall survival; disease-free survival

Outcome Measures

Primary Outcomes (1)

• overall survival

  the time from surgery until death from any cause

  5 years

Secondary Outcomes (2)

• disease-free survival

  5 years

• occurrence of surgical morbidities

  5 years

Study Arms (1)

ACOSOG Z0011 no further ALND arm

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

Procedure: no further ALND arm

Interventions

no further ALND arm PROCEDURE

Patients meeting the Z0011 inclusion criteria to receive no additional ALND

ACOSOG Z0011 no further ALND arm

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

histologically confirmed invasive breast cancer patients, who meeting the critiera of Z0011 inclusion: T1 or T2 tumor,1 or 2 positive sentinel lymph nodes,breast-conserving surgery and whole-breast RT planned is enrolled.

You may qualify if:

• histologically confirmed invasive breast cancer T1 or T2 tumor 1 or 2 positive sentinel lymph nodes breast-conserving surgery whole-breast RT planned

You may not qualify if:

• preoperative therapy 3 or more positive sentinel lymph nodes patients undergoing additional mastectomy due to positive surgical margins

Sponsors & Collaborators

• Peking University People's Hospital: lead

Study Sites (1)

Peking university people's hospital

Beijing, Beijing Municipality, 100044, China

Location

Related Publications (1)

• Peng 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 RESULT

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• shu wang

  Peking University People's Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 5 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Peking University People's Hospital Breast Center

Study Record Dates

• First Submitted: July 20, 2018
• First Posted: July 31, 2018
• Study Start: November 1, 2014
• Primary Completion: November 30, 2019
• Study Completion: November 30, 2019
• Last Updated: October 18, 2022

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)