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

NCT ID: NCT05663021

Last Updated: 2022-12-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 191 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-07-01
• Study Completion Date: 2022-02-28

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.

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.

Conditions

Breast Cancer

Keywords

neoadjuvant chemotherapy; nodal response; core needle biopsy

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Ultrasound-guided core needle biopsy in breast

Intervention Type: 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.

Interventions

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.

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Fudan University

OTHER

Sponsor Role: lead

Responsible Party

Zhimin Shao

Director of Department of Breast Surgery

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Zhi-Min Shao

Shanghai, Shanghai Municipality, China

Countries

China

Other Identifiers

FIERCE

Identifier Type: -

Identifier Source: org_study_id