NCT02948764: RESPONDER

Diagnosis of Pathological Complete Response by Vacuum-assisted Biopsy After Neoadjuvant Chemotherapy in Breast Cancer

Completed NA Last updated 25 March 2020

What this trial tests

NA trial testing Vacuum-Assisted Biopsy in Breast Neoplasms in 452 participants. Completed in 15 September 2019.

Timeline

8 March 2017

Primary endpoint
24 May 2019

15 September 2019

Quick facts

Lead sponsor	Heidelberg University
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	diagnostic
Enrollment	452
Start date	8 March 2017
Primary completion	24 May 2019
Estimated completion	15 September 2019
Sites	1 location across Germany

Drugs / interventions tested

• Vacuum-Assisted Biopsy

Conditions studied

• Breast Neoplasms — all drugs for Breast Neoplasms →

Sponsor

Heidelberg University

Who can join

18 and older, female only, with Breast Neoplasms. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Minimally Invasive Complete Response Assessment of the Breast After Neoadjuvant Systemic Therapy for Early Breast Cancer (MICRA trial): Interim Analysis of a Multicenter Observational Cohort Study.
   van Loevezijn AA, van der Noordaa MEM, van Werkhoven ED, Loo CE, et al · · 2021 · cited 59× · PMID 33263830 · DOI 10.1245/s10434-020-09273-0
2. 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.
   Pfob A, Sidey-Gibbons C, Rauch G, Thomas B, et al · · 2022 · cited 54× · PMID 35108029 · DOI 10.1200/jco.21.02439
3. 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 J, Sinn P, Richter H, Pfob A, et al · · 2018 · cited 33× · PMID 30144818 · DOI 10.1186/s12885-018-4760-4
4. Vacuum-Assisted Breast Biopsy After Neoadjuvant Systemic Treatment for Reliable Exclusion of Residual Cancer in Breast Cancer Patients.
   Koelbel V, Pfob A, Schaefgen B, Sinn P, et al · · 2022 · cited 19× · PMID 34581923 · DOI 10.1245/s10434-021-10847-9
5. Identifying research priorities in breast cancer surgery: a UK priority setting partnership with the James Lind Alliance.
   Potter S, Fairhurst K, Cowan K, Vincent S, et al · · 2023 · cited 18× · PMID 36319906 · DOI 10.1007/s10549-022-06756-4
6. A review of studies on omitting surgery after neoadjuvant chemotherapy in breast cancer.
   Feng K, Jia Z, Liu G, Xing Z, et al · · 2022 · cited 17× · PMID 36119847
7. Accuracy of Breast Ultrasonography and Mammography in Comparison with Postoperative Histopathology in Breast Cancer Patients after Neoadjuvant Chemotherapy.
   Schmidt G, Findeklee S, Del Sol Martinez G, Georgescu MT, et al · · 2023 · cited 10× · PMID 37685349 · DOI 10.3390/diagnostics13172811
8. Biopsy-Guided Pathological Response Assessment in Breast Cancer is Insufficient: Additional Pathology Findings of the MICRA Trial.
   van Hemert AKE, van Duijnhoven FH, van Loevezijn AA, Loo CE, et al · · 2023 · cited 8× · PMID 37071235 · DOI 10.1245/s10434-023-13476-6