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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-09-08

Study Completion Date

2018-02-01

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Breast Neoplasm

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Comparison of pathological findings for residual tumor between minimally-invasive biopsy procedure and subsequent wide excision of the biopsied area

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Core needle Biopsy

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

Group Type EXPERIMENTAL

Minimally-invasive biopsy

Intervention Type PROCEDURE

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

wide excision

Intervention Type PROCEDURE

Surgical wide excision of the biopsied area.

Vacuum-assisted biopsy

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

Group Type EXPERIMENTAL

Minimally-invasive biopsy

Intervention Type PROCEDURE

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

wide excision

Intervention Type PROCEDURE

Surgical wide excision of the biopsied area.

Interventions

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Minimally-invasive biopsy

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

Intervention Type PROCEDURE

wide excision

Surgical wide excision of the biopsied area.

Intervention Type PROCEDURE

Other Intervention Names

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vacuum-assisted biopsy core-needle biopsy

Eligibility Criteria

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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