RESPONDER Trial - Diagnosis of pathological complete RESPonse by vacuum-assisted biOpsy after NeoaDjuvant chemotherapy in brEast canceR

• Applicant: Professor Dr. Jörg Heil
• Subject Area: Gynaecology and Obstetrics ; Hematology, Oncology
• Term: from 2016 to 2019
• Project identifier: Deutsche Forschungsgemeinschaft (DFG) - Project number 286676905

Chemotherapy before surgery (=neoadjuvant chemotherapy, NAGT) is increasingly used in breast cancer treatment. Moreover, a pathological complete response in the breast (pCR-B = no tumor cells survived NAGT) is achieved with growing frequency. This scenario provokes the widely debated issue whether local treatment (surgery and / or radiotherapy) is actually beneficial in patients experiencing a pCR-B. Any type of breast cancer surgery as weil as radiotherapy is associated with the risk of physical and psychological morbidity. Should these procedures prove not to serve any therapeutic purpose, patients deserve to be spared its' negative effects.However, before this question regarding the therapeutic benefit of local treatment can be investigated, it is essential to prove that a reliable diagnosis of pCR-B is possible without surgery. Nowadays, a pCR-B can only be confirmed by the histopathologic evaluation of the surgical specimen; imaging methods as ultrasound, mammography or MRI do not provide a valid prediction.This proposed multicenter, confirmative, clinical trial aims to confirm that a pCR-B can be validly diagnosed by using vacuum-assisted, minimal invasive biopsy techniques (VAB). Within this study the VAB will be performed after NAGT and before standard surgical treatment which will be carried out in every patient. We will include 600 patients with at least partial response in ultrasound and/or mammography and/or MRI. The aim of the study is to confirm that less than 10% of the patients with a residual tumor after NAGT are falsely classified as having no residual tumor by the VAB.

• DFG Programme: Clinical Trials