Feasibility in Identification of Breast Cancer Candidates for Elimination of Axillary Surgery
Condition: Breast Cancer
MeSH terms: Breast Neoplasms
Study type: Interventional

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.
    

Intervention name(s): Ultrasound-guided core needle biopsy in breast
Intervention type(s): Diagnostic Test
Intervention description(s): 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 model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: neoadjuvant chemotherapy; nodal response; core needle biopsy