Prediction of pCR by Preoperative Biopsy in Breast Cancer With cCR After Neoadjuvant Chemotherapy.
Primary Purpose
Breast Neoplasm
Status
Completed
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Minimally-invasive biopsy
wide excision
Sponsored by
About this trial
This is an interventional diagnostic trial for Breast Neoplasm
Eligibility Criteria
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
Sites / Locations
- Seoul National University Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Core needle Biopsy
Vacuum-assisted biopsy
Arm Description
Ultrasound-guided core needle biopsy (14G, ≥5 cores recommended) for complete clinical response (cCR) or near-cCR predicted by MRI.
Vacuum-assisted biopsy (10G, ≥5 cores recommended) for complete clinical response (cCR) or near-cCR predicted by MRI.
Outcomes
Primary Outcome Measures
Negative Predictive Value
Percentage of participants with pathologic complete response (pCR) confirmed by surgical excision in patients predicted by biopsy to have pCR
Secondary Outcome Measures
False Negative Rate
Percentage of participants with pathologic complete response (pCR) confirmed by surgical excision in patients predicted by biopsy to have pCR
Full Information
NCT ID
NCT03273426
First Posted
September 4, 2017
Last Updated
March 27, 2020
Sponsor
Seoul National University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT03273426
Brief Title
Prediction of pCR by Preoperative Biopsy in Breast Cancer With cCR After Neoadjuvant Chemotherapy.
Official Title
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.
Study Type
Interventional
2. Study Status
Record Verification Date
March 2020
Overall Recruitment Status
Completed
Study Start Date
September 8, 2016 (Actual)
Primary Completion Date
February 1, 2018 (Actual)
Study Completion Date
February 1, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Seoul National University Hospital
4. Oversight
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
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Neoplasm
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Comparison of pathological findings for residual tumor between minimally-invasive biopsy procedure and subsequent wide excision of the biopsied area
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
40 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Core needle Biopsy
Arm Type
Experimental
Arm Description
Ultrasound-guided core needle biopsy (14G, ≥5 cores recommended) for complete clinical response (cCR) or near-cCR predicted by MRI.
Arm Title
Vacuum-assisted biopsy
Arm Type
Experimental
Arm Description
Vacuum-assisted biopsy (10G, ≥5 cores recommended) for complete clinical response (cCR) or near-cCR predicted by MRI.
Intervention Type
Procedure
Intervention Name(s)
Minimally-invasive biopsy
Other Intervention Name(s)
vacuum-assisted biopsy, core-needle biopsy
Intervention Description
Intervention (core needle biopsy (14G) or vacuum-assisted biopsy(10G)) for complete clinical response (cCR) or near-cCR predicted by MRI.
Intervention Type
Procedure
Intervention Name(s)
wide excision
Intervention Description
Surgical wide excision of the biopsied area.
Primary Outcome Measure Information:
Title
Negative Predictive Value
Description
Percentage of participants with pathologic complete response (pCR) confirmed by surgical excision in patients predicted by biopsy to have pCR
Time Frame
2 weeks
Secondary Outcome Measure Information:
Title
False Negative Rate
Description
Percentage of participants with pathologic complete response (pCR) confirmed by surgical excision in patients predicted by biopsy to have pCR
Time Frame
2 weeks
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Wonshik Han, MD, PhD
Organizational Affiliation
Seoul National University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Seoul National University Hospital
City
Seoul
ZIP/Postal Code
03080
Country
Korea, Republic of
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing 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.
Citations:
PubMed Identifier
33307491
Citation
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.
Results Reference
derived
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Prediction of pCR by Preoperative Biopsy in Breast Cancer With cCR After Neoadjuvant Chemotherapy.
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