Clinical trial NCT05663021: Feasibility in Identification of Breast Cancer Candidates for Elimination of Axillary Surgery
Official title: Feasibility in Identification of Suitable Candidates for Elimination of Axillary Surgery in Breast Cancer Patients With Initial Biopsy-confirmed Nodal Metastases
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breast Cancer
Keywords: neoadjuvant chemotherapy
nodal response
core needle biopsy
Lead sponsor: Fudan University
Sponsor class: OTHER
First posted: 2022-12-23
Enrollment: 191
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.

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

Primary outcomes:
measure: 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
timeFrame: 1 day
Secondary outcomes:
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Zhi-Min Shao
state: Shanghai
Study officials:
References: