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

Not Applicable

Completed

• Conditions: Breast Neoplasm
• Interventions: Procedure: Minimally-invasive biopsy; Procedure: wide excision

• Registration Number: NCT03273426
• Lead Sponsor: Seoul National University Hospital

Brief 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.

Study Timeline

• Study Start: 2016-09-08
• Study First Submitted: 2017-09-04
• Study First Submitted QC: 2017-09-04
• Study First Posted: 2017-09-06
• Primary Completion: 2018-02-01
• Study Completion: 2018-02-01
• Results First Submitted: 2019-09-25
• Status Verified: 2020-03
• Results First Submitted QC: 2020-03-27
• Last Update Submitted: 2020-03-27
• Results First Posted: 2020-04-09
• Last Update Posted: 2020-04-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 40

Inclusion Criteria

Patients

• with unilateral primary cancer pathologically confirmed before neoadjuvant chemotherapy (NAC)
• who received NAC
• with detectable lesion / clip marker on ultrasound
• with cT1-T3 tumors
• clinical and imaging complete or near-complete response on MRI
• with informed consent

Exclusion Criteria

• Multifocal cancer
• Residual microcalcification
• Contralateral breast cancer

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Vacuum-assisted biopsy	Minimally-invasive biopsy	Vacuum-assisted biopsy (10G, ≥5 cores recommended) for complete clinical response (cCR) or near-cCR predicted by MRI.
Vacuum-assisted biopsy	wide excision	Vacuum-assisted biopsy (10G, ≥5 cores recommended) for complete clinical response (cCR) or near-cCR predicted by MRI.
Core needle Biopsy	wide excision	Ultrasound-guided core needle biopsy (14G, ≥5 cores recommended) for complete clinical response (cCR) or near-cCR predicted by MRI.
Core needle Biopsy	Minimally-invasive biopsy	Ultrasound-guided core needle biopsy (14G, ≥5 cores recommended) for complete clinical response (cCR) or near-cCR predicted by MRI.

Primary Outcome Measures

Name	Time	Method
Negative Predictive Value	2 weeks	Percentage of participants with pathologic complete response (pCR) confirmed by surgical excision in patients predicted by biopsy to have pCR

Secondary Outcome Measures

Name	Time	Method
False Negative Rate	2 weeks	Percentage of participants with pathologic complete response (pCR) confirmed by surgical excision in patients predicted by biopsy to have pCR

Trial Locations

Locations (1)

Seoul National University Hospital; 🇰🇷 Seoul, Korea, Republic of