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

NCT05663021 | Completed DMC

• 1 other identifier: FIERCE
• Study Type: interventional
• Target: 191
• Locations: 1 country
• Sites: 1

Brief 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

Breast Cancer

Keywords

neoadjuvant chemotherapy; nodal response; core needle biopsy

Outcome Measures

Primary Outcomes (1)

• Diagnostic Accuracy of Ultrasound-Guided Core Biopsy of Initial Breast Cancer Region Compared to Axillary Surgery with Pathologic Evaluation Cancer Region Compared to Standard Surgery with Pathologic Evaluation

  Accuracy of core biopsy determined by biopsy results to the axillary pathologic evaluation removed during standard surgery. Estimates and 95% confidence intervals for accuracy, sensitivity, false negative rate (FNR), specificity as well as the negative predictive value (NPV) reported for FNA and core biopsy based on the exact Clopper-Pearson method.

  1 day

Study Arms (1)

Ultrasound-Guided Biopsy of Tumor Site during neoadjuvant chemotherapy

EXPERIMENTAL

For patients who were not evaluated as progressive disease by the latest imaging measurement, repeated CNB (RCNB) was performed after 2-4 cycles of NAC, depending on the total cycles of NAC. 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.

Diagnostic Test: Ultrasound-guided core needle biopsy in breast

Interventions

Ultrasound-guided core needle biopsy in breast DIAGNOSTIC_TEST

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.

Ultrasound-Guided Biopsy of Tumor Site during neoadjuvant chemotherapy

Eligibility Criteria

• Age: 18 Years - 70 Years
• Gender Eligibility Details: female breast cancer patients are enrolled
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Clinical stage T1-4 N1-3M0 breast cancer at diagnosis (prior to neoadjuvant chemotherapy) by American Joint Committee on Cancer (AJCC) staging 7th edition
• Aged above 18 and below 70 years
• No other malignancy within 5 years of registration with the exception of basal cell or squamous cell carcinoma of the skin treated with local resection only or carcinoma in situ of the cervix
• Patients must have had estrogen receptor, progesterone receptor and HER2 status (by immunohistochemistry \[IHC\] and/or in situ hybridization \[ISH\]) evaluated on core needle biopsy prior to starting neoadjuvant chemotherapy
• Completing all planned cycles and regimens of neoadjuvant chemotherapy followed by axillary surgery

You may not qualify if:

• Nonrepresentative core needle biopsy in the breast during neoadjuvant chemotherapy
• Inflammatory breast cancer

Sponsors & Collaborators

• Fudan University: lead

Study Sites (1)

Zhi-Min Shao

Shanghai, Shanghai Municipality, 200030, China

Location

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Department of Breast Surgery

Study Record Dates

• First Submitted: December 14, 2022
• First Posted: December 23, 2022
• Study Start: July 1, 2017
• Primary Completion: June 26, 2021
• Study Completion: February 28, 2022
• Last Updated: December 23, 2022

Record last verified: 2022-12

Locations

CN (1)