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Feasibility in Identification of Breast Cancer Candidates for Elimination of Axillary Surgery

NCT05663021 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 191

Last updated 2022-12-23

No results posted yet for this study

Summary

Preoperative identification of patients with pathologic complete response or residual disease in axilla can aid in tailoring subsequent axillary surgery including omission of axillary surgery based on tumor biology and response to neoadjuvant chemotherapy.

Conditions

Interventions

DIAGNOSTIC_TEST

Ultrasound-guided core needle biopsy in breast

For patients who were not evaluated as progressive disease by the latest imaging measurement, repeated core needle biopsy is conducted within the baseline tattooed area after 2 to 4 cycles of neoadjuvant chemotherapy, depending on the total cycles of chemotherapy. Tissue is acquired from different sections of the lesion from different angles to minimize the impact of tumor heterogeneity. For each patient, 3 to 4 tissue specimens are collected and sent for pathological review to examine whether there is residual malignancy (residual cancer, pleomorphic tissue) in the tumor site that is tattooed.

Sponsors & Collaborators

  • Fudan University

    lead OTHER

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-07-01
Primary Completion
2021-06-26
Completion
2022-02-28

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05663021 on ClinicalTrials.gov