NCT03273426

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2016

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 8, 2016

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

September 4, 2017

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 6, 2017

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2018

Completed
2.2 years until next milestone

Results Posted

Study results publicly available

April 9, 2020

Completed
Last Updated

April 9, 2020

Status Verified

March 1, 2020

Enrollment Period

1.4 years

First QC Date

September 4, 2017

Results QC Date

September 25, 2019

Last Update Submit

March 27, 2020

Conditions

Breast Neoplasm

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • False Negative Rate

    2 weeks

Study Arms (2)

Core needle Biopsy

EXPERIMENTAL

Ultrasound-guided core needle biopsy (14G, ≥5 cores recommended) for complete clinical response (cCR) or near-cCR predicted by MRI.

Procedure: Minimally-invasive biopsyProcedure: wide excision

Vacuum-assisted biopsy

EXPERIMENTAL

Vacuum-assisted biopsy (10G, ≥5 cores recommended) for complete clinical response (cCR) or near-cCR predicted by MRI.

Procedure: Minimally-invasive biopsyProcedure: wide excision

Interventions

Minimally-invasive biopsyPROCEDURE

Intervention (core needle biopsy (14G) or vacuum-assisted biopsy(10G)) for complete clinical response (cCR) or near-cCR predicted by MRI.

Also known as: vacuum-assisted biopsy, core-needle biopsy
Core needle BiopsyVacuum-assisted biopsy
wide excisionPROCEDURE

Surgical wide excision of the biopsied area.

Core needle BiopsyVacuum-assisted biopsy

Eligibility Criteria

Age18 Years - 80 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Multifocal cancer
  • Residual microcalcification
  • Contralateral breast cancer

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Seoul National University Hospital

Seoul, 03080, South Korea

Location

Related Publications (1)

  • 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.

    PMID: 33307491DERIVED

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Biopsy, Needle

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

BiopsyCytodiagnosisCytological TechniquesClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisSpecimen HandlingDiagnostic Techniques, SurgicalSurgical Procedures, OperativePuncturesInvestigative Techniques

Results Point of Contact

Title
Dr. Wonshik Han
Organization
Seoul National University Hospital
hanw@snu.ac.kr
+82-2-2072-1958

Study Officials

  • Wonshik Han, MD, PhD

    Seoul National University Hospital

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Model Details: Comparison of pathological findings for residual tumor between minimally-invasive biopsy procedure and subsequent wide excision of the biopsied area
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

September 4, 2017

First Posted

September 6, 2017

Study Start

September 8, 2016

Primary Completion

February 1, 2018

Study Completion

February 1, 2018

Last Updated

April 9, 2020

Results First Posted

April 9, 2020

Record last verified: 2020-03

Data Sharing

IPD Sharing
Will share

IPD including study protocol, informed consent form, clinical study report and analytic code will be shared.

Shared Documents
STUDY PROTOCOL, ICF, CSR, ANALYTIC CODE
Time Frame
Starting 6 months after publication.
Access Criteria
PI will review requests for IPD.

Locations

KR(1)