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
• Status: Completed
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Breast Neoplasm
• Breast Neoplasms

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