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.

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.

Study Overview

• Status: Completed
• Conditions: Breast Neoplasm
• Intervention / Treatment: Procedure: Minimally-invasive biopsy; Procedure: wide excision

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 Type: Interventional
• Enrollment (Actual): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of, 03080
    • Seoul National University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Core needle Biopsy; Ultrasound-guided core needle biopsy (14G, ≥5 cores recommended) for complete clinical response (cCR) or near-cCR predicted by MRI.	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.; Other Names: vacuum-assisted biopsy; core-needle biopsy; Procedure: wide excision; Surgical wide excision of the biopsied area.
Experimental: Vacuum-assisted biopsy; Vacuum-assisted biopsy (10G, ≥5 cores recommended) for complete clinical response (cCR) or near-cCR predicted by MRI.	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.; Other Names: vacuum-assisted biopsy; core-needle biopsy; Procedure: wide excision; Surgical wide excision of the biopsied area.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Seoul National University Hospital
• Investigators: Principal Investigator: Wonshik Han, MD, PhD, Seoul National University Hospital

Publications and helpful links

General Publications

• Pfob A, Sidey-Gibbons C, Lee HB, Tasoulis MK, Koelbel V, Golatta M, Rauch GM, Smith BD, Valero V, Han W, MacNeill F, Weber WP, Rauch G, Kuerer HM, Heil J. Identification of breast cancer patients with pathologic complete response in the breast after neoadjuvant systemic treatment by an intelligent vacuum-assisted biopsy. Eur J Cancer. 2021 Jan;143:134-146. doi: 10.1016/j.ejca.2020.11.006. Epub 2020 Dec 8.

Study record dates

Study Major Dates

• Study Start (Actual): September 8, 2016
• Primary Completion (Actual): February 1, 2018
• Study Completion (Actual): February 1, 2018

Study Registration Dates

• First Submitted: September 4, 2017
• First Submitted That Met QC Criteria: September 4, 2017
• First Posted (Actual): September 6, 2017

Study Record Updates

• Last Update Posted (Actual): April 9, 2020
• Last Update Submitted That Met QC Criteria: March 27, 2020
• Last Verified: March 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms
• Other Study ID Numbers: SNUHBCC002

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Plan Description: IPD including study protocol, informed consent form, clinical study report and analytic code will be shared.
• IPD Sharing Time Frame: Starting 6 months after publication.
• IPD Sharing Access Criteria: PI will review requests for IPD.
• IPD Sharing Supporting Information Type: Study Protocol; Informed Consent Form (ICF); Clinical Study Report (CSR); Analytic Code

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes