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

Feasibility in Identification of Suitable Candidates for Elimination of Axillary Surgery in Breast Cancer Patients With Initial Biopsy-confirmed Nodal Metastases

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.

Study Overview

• Status: Completed
• Conditions: Breast Cancer
• Intervention / Treatment: Diagnostic test: Ultrasound-guided core needle biopsy in breast

Detailed Description

OBJECTIVE:

To determine the accuracy of on-treatment core needle biopsy in breast to predict nodal response after neoadjuvant chemotherapy.

OUTLINE:

Early breast cancer patients aged above 18 and below 70 years with biopsy-confirmed, clinically T1-4, N1-3, and M0 disease are eligible for this study. Breast cancer is proven pathologically in all patients using the baseline core needle biopsy, and the skin of all patients is tattooed at the baseline. Metastatic lymph nodes are diagnosed with core needle biopsy or fine needle aspiration. All the patients undergo clip placement into node with biopsy-confirmed metastases at the time of diagnosis. 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., 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.

All the patients receive planned axillary surgery after completion of neoadjuvant chemotherapy. the surgical approach was determined by the treating breast surgical oncologist including targeted axillary dissection (TAD) or axillary lymph node dissection, mainly based on the intraoperative TAD results

PROJECTED ACCRUAL: A total of 180 patients will be accrued for this study within 5 years.

• Study Type: Interventional
• Enrollment (Actual): 191
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China, 200030
      • Zhi-Min Shao

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 68 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

1. Clinical stage T1-4 N1-3M0 breast cancer at diagnosis (prior to neoadjuvant chemotherapy) by American Joint Committee on Cancer (AJCC) staging 7th edition
2. Aged above 18 and below 70 years
3. 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
4. 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
5. Completing all planned cycles and regimens of neoadjuvant chemotherapy followed by axillary surgery

Exclusion Criteria:

1. Nonrepresentative core needle biopsy in the breast during neoadjuvant chemotherapy
2. Inflammatory breast cancer

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Ultrasound-Guided Biopsy of Tumor Site during neoadjuvant chemotherapy; 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; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Fudan University

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2017
• Primary Completion (Actual): June 26, 2021
• Study Completion (Actual): February 28, 2022

Study Registration Dates

• First Submitted: December 14, 2022
• First Submitted That Met QC Criteria: December 14, 2022
• First Posted (Estimate): December 23, 2022

Study Record Updates

• Last Update Posted (Estimate): December 23, 2022
• Last Update Submitted That Met QC Criteria: December 14, 2022
• Last Verified: December 1, 2022

More Information

Terms related to this study

• Keywords: neoadjuvant chemotherapy; nodal response; core needle biopsy
• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms
• Other Study ID Numbers: FIERCE

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No