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Diagnosis of Pathological Complete Response by Vacuum-assisted Biopsy After Neoadjuvant Chemotherapy in Breast Cancer

NCT02948764 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 452

Last updated 2020-03-25

No results posted yet for this study

Summary

The main purpose of the study is to evaluate the potential of a minimal invasive, vacuum-assisted biopsy (VAB) to reliably diagnose a pathological complete response (pCR) in the breast after neoadjuvant chemotherapy (NACT) in breast cancer patients.

The study is designed as a multicenter, confirmative, one-armed, intra-individually-controlled, open, diagnostic trial, in which we aim to confirm the applicability of preoperative VAB in patients after NACT. Furthermore, we aspire to quantify the rate of concordant pathological findings (pCR yes / no) in biopsy and surgical specimen.

Conditions

  • Breast Neoplasms

Interventions

DEVICE

Vacuum-Assisted Biopsy

The vacuum-assisted (7-10G), minimal invasive biopsy (VAB), either guided by ultrasound, or by mammography (stereotaxy) during the second trial visit (V2) will be performed once. In analogy to the German S3 guideline on primary breast cancer management we recommend to take at least 12 biopsies with 10G needles or less in case of larger needle sizes.

Sponsors & Collaborators

  • German Research Foundation

    collaborator OTHER

  • Heidelberg University

    lead OTHER

Principal Investigators

  • Joerg Heil, Professor · University of Heidelberg University Breast Unit, Department of Gynecology

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-03-08
Primary Completion
2019-05-24
Completion
2019-09-15

Countries

  • Germany

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02948764 on ClinicalTrials.gov