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Clinical Trial
. 2018 Aug 25;18(1):851.
doi: 10.1186/s12885-018-4760-4.

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

Joerg Heil  1 , Peter Sinn  2 , Hannah Richter  3 , André Pfob  3 , Benedikt Schaefgen  3 , André Hennigs  3 , Fabian Riedel  3 , Bettina Thomas  4 , Marc Thill  5 , Markus Hahn  6 , Jens-Uwe Blohmer  7 , Sherko Kuemmel  8 , Maria Margarete Karsten  7 , Mattea Reinisch  8 , John Hackmann  9 , Toralf Reimer  10 , Geraldine Rauch  11   12   13 , Michael Golatta  3
Affiliations
Clinical Trial

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

Joerg Heil et al. BMC Cancer. .

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.

Keywords: Breast cancer; Neoadjuvant chemotherapy; Treatment response evaluation; Vacuum-assisted biopsy.

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Conflict of interest statement

Ethics approval and consent to participate

Before the start of the trial, the trial protocol, informed consent document, and any other appropriate documents were submitted to the independent Ethics Committee (EC). Ethical approval has been obtained for the lead investigator’s site by the Ethics Committee of the Medical Faculty Heidelberg (Reference number S-264/2016, July 13th 2016).

Before being admitted to the clinical trial, all subjects must consent to participate after the nature, scope, and possible consequences of the clinical trial have been explained in a form understandable to her. Each subject must give consent in writing.

Consent for publication

Not applicable.

Competing interests

The authors declare that they have no competing interests.

Publisher’s Note

Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.

References

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