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NCT03273426 Clinical Trial

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

Breast Neoplasm Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03273426
Other study ID # SNUHBCC002
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date September 8, 2016
Est. completion date February 1, 2018

Study information
Verified date March 2020
Source Seoul National University Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 40
Est. completion date February 1, 2018
Est. primary completion date February 1, 2018
Accepts healthy volunteers No
Gender Female
Age group 18 Years to 80 Years
Eligibility 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

Related Conditions & MeSH terms

Intervention

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.
• wide excision
Surgical wide excision of the biopsied area.

Locations
Country Name City State
Korea, Republic of Seoul National University Hospital Seoul

Sponsors (1)
Lead Sponsor Collaborator
Seoul National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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 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
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