NCT03273426

Prediction of pCR by Preoperative Biopsy in Breast Cancer With cCR After Neoadjuvant Chemotherapy.

Prediction of Pathologic Complete Response by Multiple Core Needle Biopsy or Vacuum Assisted Biopsy Before Surgery in Breast Cancer With Complete Clinical Response After Neoadjuvant Chemotherapy.

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: Seoul National University Hospital · Academic / Other
• Sex: Female
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate the ability of preoperative biopsy to predict correctly pathologic complete response in breast cancer patients with complete clinical response after neoadjuvant chemotherapy.

Detailed description

Breast cancer patients who received neoadjuvant chemotherapy and is predicted to have achieved pathologic complete response (pCR) on MRI will enrolled. The enrolled patients will undergo either US-guided multiple core needle biopsy or US-guided vacuum-assisted biopsy of the tumor bed where it had been marked with an indicator (clip). The patient will undergo subsequent wide excision of the tumor bed. Histopathologic findings of the biopsy and the surgical specimen will be compared for pCR, and the ability of preoperative biopsies to predict pCR will be evaluated.

Conditions

• Breast Neoplasm

Interventions

Type	Name	Description
PROCEDURE	Minimally-invasive biopsy	Intervention (core needle biopsy (14G) or vacuum-assisted biopsy(10G)) for complete clinical response (cCR) or near-cCR predicted by MRI.
PROCEDURE	wide excision	Surgical wide excision of the biopsied area.

Timeline

• Start date: 2016-09-08
• Primary completion: 2018-02-01
• Completion: 2018-02-01
• First posted: 2017-09-06
• Last updated: 2020-04-09
• Results posted: 2020-04-09

Locations

1 site across 1 country: South Korea