Directly to content
  1. Publishing |
  2. Search |
  3. Browse |
  4. Recent items rss |
  5. Open Access |
  6. Jur. Issues |
  7. DeutschClear Cookie - decide language by browser settings

RESPONDER – diagnosis of pathological complete response by vacuum-assisted biopsy after neoadjuvant chemotherapy in breast Cancer - a multicenter, confirmative, one-armed, intra-individually-controlled, open, diagnostic trial

Heil, Joerg ; Sinn, Peter ; Richter, Hannah ; Pfob, André ; Schaefgen, Benedikt ; Hennigs, André ; Riedel, Fabian ; Thomas, Bettina ; Thill, Marc ; Hahn, Markus ; Blohmer, Jens-Uwe ; Kuemmel, Sherko ; Karsten, Maria Margarete ; Reinisch, Mattea ; Hackmann, John ; Reimer, Toralf ; Rauch, Geraldine ; Golatta, Michael

In: BMC Cancer, 18 (2018), Nr. 851. pp. 1-7. ISSN 1471-2407

[thumbnail of 12885_2018_Article_4760.pdf]
Preview
PDF, English
Download (573kB) | Lizenz: Creative Commons LizenzvertragRESPONDER – diagnosis of pathological complete response by vacuum-assisted biopsy after neoadjuvant chemotherapy in breast Cancer - a multicenter, confirmative, one-armed, intra-individually-controlled, open, diagnostic trial by Heil, Joerg ; Sinn, Peter ; Richter, Hannah ; Pfob, André ; Schaefgen, Benedikt ; Hennigs, André ; Riedel, Fabian ; Thomas, Bettina ; Thill, Marc ; Hahn, Markus ; Blohmer, Jens-Uwe ; Kuemmel, Sherko ; Karsten, Maria Margarete ; Reinisch, Mattea ; Hackmann, John ; Reimer, Toralf ; Rauch, Geraldine ; Golatta, Michael underlies the terms of Creative Commons Attribution 4.0

Citation of documents: Please do not cite the URL that is displayed in your browser location input, instead use the DOI, URN or the persistent URL below, as we can guarantee their long-time accessibility.

Abstract

Background: Neoadjuvant chemotherapy (NACT) is a standard approach of the multidisciplinary treatment of breast cancer. Depending on the biological subtype a pathological complete response in the breast (bpCR) can be achieved in up to 60% of the patients. However, only limited accuracy can be reached when using imaging for prediction of bpCR prior to surgery. Due to this diagnostic uncertainty, surgery after NACT is considered to be obligatory for all patients in order to either completely remove residual disease or to diagnose a bpCR histologically. The purpose of this trial is to evaluate the accuracy of a vacuum-assisted biopsy (VAB) to diagnose a bpCR after NACT prior to surgery.

Methods: This study is a multicenter, confirmative, one-armed, intra-individually-controlled, open, diagnostic trial. The study will take place at 21 trial sites in Germany. Six hundred female patients with breast cancer after completed NACT showing at least a partial response to NACT treatment will be enrolled. A vacuum-assisted biopsy (VAB) guided either by ultrasound or mammography will be performed followed by histopathological evaluation of the VAB specimen before standard, guideline-adherent breast surgery. The study is designed to prove that the false negative rate of the VAB is below 10%.

Discussion: As a bpCR is becoming a more frequent result after NACT, the question arises whether breast surgery is therapeutically necessary in such cases. To study this subject further, it will be crucial to develop a reliable test to diagnose a bpCR without surgery. During the study we anticipate possible problems in patient recruitment as the VAB intervention does not provide participating patients with any personal benefit. Hence, a proficient informed consent discussion with the patient and a detailed explanation of the study aim will be crucial for patient recruitment. Another critical issue is the histopathological VAB evaluation of a non-tumorous specimen as this may have been taken either from the former tumor region (bpCR) or outside of the (former) tumor region (non-representative VAB, sampling error).

Trial registration: The trial has been registered at clinicaltrials.gov with the identifier NCT02948764 on October 28, 2016 and at the German Clinical Trials Register ( DRKS00011761 ) on February 20, 2017. The date of enrolment of the first participant to the trial was on March 8, 2017.

Document type: Article
Journal or Publication Title: BMC Cancer
Volume: 18
Number: 851
Publisher: Biomed Central ; Springer
Place of Publication: London ; Berlin ; Heidelberg
Date Deposited: 30 Oct 2018 10:02
Date: 2018
ISSN: 1471-2407
Page Range: pp. 1-7
Faculties / Institutes: Medizinische Fakultät Heidelberg > Universitäts-Frauenklinik
Medizinische Fakultät Heidelberg > Institut für Medizinische Biometrie und Informatik
Medizinische Fakultät Heidelberg > Pathologisches Institut
DDC-classification: 610 Medical sciences Medicine
About | FAQ | Contact | Imprint |
OA-LogoDINI certificate 2013Logo der Open-Archives-Initiative