eprintid: 25448 rev_number: 15 eprint_status: archive userid: 1589 dir: disk0/00/02/54/48 datestamp: 2018-10-30 10:02:49 lastmod: 2024-04-07 23:18:16 status_changed: 2018-10-30 10:02:49 type: article metadata_visibility: show creators_name: Heil, Joerg creators_name: Sinn, Peter creators_name: Richter, Hannah creators_name: Pfob, André creators_name: Schaefgen, Benedikt creators_name: Hennigs, André creators_name: Riedel, Fabian creators_name: Thomas, Bettina creators_name: Thill, Marc creators_name: Hahn, Markus creators_name: Blohmer, Jens-Uwe creators_name: Kuemmel, Sherko creators_name: Karsten, Maria Margarete creators_name: Reinisch, Mattea creators_name: Hackmann, John creators_name: Reimer, Toralf creators_name: Rauch, Geraldine creators_name: Golatta, Michael title: 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 subjects: 610 divisions: 910400 divisions: 911800 divisions: 912000 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. date: 2018 publisher: Biomed Central ; Springer id_scheme: DOI ppn_swb: 1658546377 own_urn: urn:nbn:de:bsz:16-heidok-254489 language: eng bibsort: HEILJOERGRESPONDERD2018 full_text_status: public publication: BMC Cancer volume: 18 number: 851 place_of_pub: London ; Berlin ; Heidelberg pagerange: 1-7 issn: 1471-2407 citation: 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 (2018) 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. BMC Cancer, 18 (851). pp. 1-7. ISSN 1471-2407 document_url: https://archiv.ub.uni-heidelberg.de/volltextserver/25448/1/12885_2018_Article_4760.pdf