Clinical trial · Interventional
Diagnosis of Pathological Complete Response by Vacuum-assisted Biopsy After Neoadjuvant Chemotherapy in Breast Cancer
RESPONDER Trial - Diagnosis of Pathological Complete Response by Vacuum-assisted Biopsy After Neoadjuvant Chemotherapy in Breast Cancer
NCT02948764CI-TRIAL-00044228RESPONDERcompletedN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Neoplasms | Breast Neoplasm | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Vacuum-Assisted Biopsy | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- OTHER
- label
- single-arm study
- description
- This project is designed as a one-armed diagnostic study. Every patient included in the study will undergo the same diagnostic test, the vacuum-assisted biopsy, after NACT and before surgery according to guidelines.
- interventionNames
- Device: Vacuum-Assisted Biopsy
Primary outcomes (1)
- measure
- false negative VAB results, reported as the false negative rate (= FNR)
- timeFrame
- after breast surgery, up to 6 weeks after VAB
- description
- non-detected residual tumor by VAB (=index test) compared to breast surgery (=reference test): FNR = rate of patients with non-detected residual tumor by VAB compared to breast surgery Residual tumor is defined as a positive result; in surgical specimen as well as in VAB.
Secondary outcomes (3)
- measure
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria * Female patients with primary breast cancer after Neoadjuvant Chemotherapy (NACT) treatment which has been performed for at least 12 weeks and resulted in cPR or cCR (see below). * \>/=18 years * any cT and cN stage, except cT4 stages * any routine breast cancer surgical intervention planned according to guidelines (breast conservation or mastectomy) * Residual intramammary target lesion or clip marker is visible in ultrasound and / or mammography * Diagnosis of imaging complete or partial response according to RECIST 1.1 by at least mammography or ultrasound, according to local routine) * Inclusion of only one breast per patient, in bilateral cancer one breast can be included * In case of multicentric disease: confirmation of the same tumorbiological subtype defined by immunohistology in at least 2 lesions. * Ability of subject to understand character and individual consequences of the clinical trial. * Written informed consent (must be available before enrolment in the trial). Exclusion Criteria * Palliative or recurrent breast cancer * in case of clip marker = target lesion: dislocation of marker (\>5mm distance to the initial lesion border at the time of clip placement) * contraindication for VAB or associated procedures (e.g. local anesthesia) * Pregnancy and lactation * held in an institution by legal or official order * legally incapacitated.
References
Publications (5)
- RESULTSchaefgen B, Mati M, Sinn HP, Golatta M, Stieber A, Rauch G, Hennigs A, Richter H, Domschke C, Schuetz F, Sohn C, Schneeweiss A, Heil J. Can Routine Imaging After Neoadjuvant Chemotherapy in Breast Cancer Predict Pathologic Complete Response? Ann Surg Oncol. 2016 Mar;23(3):789-95. doi: 10.1245/s10434-015-4918-0. Epub 2015 Oct 14. PMID 26467456
- RESULTHeil J, Kummel S, Schaefgen B, Paepke S, Thomssen C, Rauch G, Ataseven B, Grosse R, Dreesmann V, Kuhn T, Loibl S, Blohmer JU, von Minckwitz G. Diagnosis of pathological complete response to neoadjuvant chemotherapy in breast cancer by minimal invasive biopsy techniques. Br J Cancer. 2015 Dec 1;113(11):1565-70. doi: 10.1038/bjc.2015.381. Epub 2015 Nov 10. PMID 26554654
- DERIVEDPfob A, Sidey-Gibbons C, Rauch G, Thomas B, Schaefgen B, Kuemmel S, Reimer T, Hahn M, Thill M, Blohmer JU, Hackmann J, Malter W, Bekes I, Friedrichs K, Wojcinski S, Joos S, Paepke S, Degenhardt T, Rom J, Rody A, van Mackelenbergh M, Banys-Paluchowski M, Grosse R, Reinisch M, Karsten M, Golatta M, Heil J. Intelligent Vacuum-Assisted Biopsy to Identify Breast Cancer Patients With Pathologic Complete Response (ypT0 and ypN0) After Neoadjuvant Systemic Treatment for Omission of Breast and Axillary Surgery. J Clin Oncol. 2022 Jun 10;40(17):1903-1915. doi: 10.1200/JCO.21.02439. Epub 2022 Feb 2. PMID 35108029
- DERIVEDPfob A, Sidey-Gibbons C, Lee HB, Tasoulis MK, Koelbel V, Golatta M, Rauch GM, Smith BD, Valero V, Han W, MacNeill F, Weber WP, Rauch G, Kuerer HM, Heil J. Identification of breast cancer patients with pathologic complete response in the breast after neoadjuvant systemic treatment by an intelligent vacuum-assisted biopsy. Eur J Cancer. 2021 Jan;143:134-146. doi: 10.1016/j.ejca.2020.11.006. Epub 2020 Dec 8. PMID 33307491
- DERIVEDHeil J, Sinn P, Richter H, Pfob A, Schaefgen B, Hennigs A, Riedel F, Thomas B, Thill M, Hahn M, Blohmer JU, Kuemmel S, Karsten MM, Reinisch M, Hackmann J, Reimer T, Rauch G, Golatta M. 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. 2018 Aug 25;18(1):851. doi: 10.1186/s12885-018-4760-4.