Evidence map›Paper›PMID 35108029›Full record

Trial reportJournal of clinical oncology : official journal of the American Society of Clinical Oncology2022

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.

André Pfob, Chris Sidey-Gibbons, Geraldine Rauch, Bettina Thomas, Benedikt Schaefgen, Sherko Kuemmel, Toralf Reimer, Markus Hahn, Marc Thill, Jens-Uwe Blohmer and 17 more

2 registry-linked trialsAbstract readClinical Trial
PubMed Publisher
In one paragraph

Trial report in Journal of clinical oncology : official journal of the American Society of Clinical Oncology, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 42 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
42citing papers in PubMed, 1 pooled it
5.9field-weighted citation impact, top 3% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT02575612 nacompletednot on this map

Can a Pathological Complete Response in the Breast be Diagnosed by Vacuum-assisted, Ultrasound Guided Minimal Invasive Biopsy After Neoadjuvant Chemotherapy in Breast Cancer Patients? A Proof of Concept From a Prospective Cohort Study

TypeinterventionalSponsorHeidelberg UniversityRan2014 to 2015Enrolled50ConditionsBreast NeoplasmsArmsvacuum-assisted biopsy
NCT02948764 nacompletednot on this map

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

TypeinterventionalSponsorHeidelberg UniversityRan2017 to 2019Enrolled452ConditionsBreast NeoplasmsArmsVacuum-Assisted Biopsy
3 · Its place in the literature

Who cites it

42 citing papers in PubMed, 1 synthesis or guideline pooled it, 66 citations in OpenAlex.

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  15. Breast cancer: pathogenesis and treatments.Signal transduction and targeted therapy · 2025
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4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

27 authors at 16 institutions in 2 countries.

André PfobUniversity Breast Unit, Department of Obstetrics & Gynecology, Heidelberg University Hospital, Heidelberg, Germany.ORCID 0000-0001-6140-9895
Chris Sidey-GibbonsMD Anderson Center for INSPiRED Cancer Care (Integrated Systems for Patient-Reported Data), The University of Texas MD Anderson Cancer Center, Houston, TX.ORCID 0000-0002-4732-7305
Geraldine RauchInstitute of Biometry and Clinical Epidemiology, Charité-Universitätsmedizin Berlin, corporate member of Freie Universität Berlin, Humboldt-Universität zu Berlin, Berlin, Germany.
Bettina ThomasCoordination Centre for Clinical Trials (KKS), University Heidelberg, Heidelberg, Germany.
Benedikt SchaefgenUniversity Breast Unit, Department of Obstetrics & Gynecology, Heidelberg University Hospital, Heidelberg, Germany.ORCID 0000-0002-9725-1716
Sherko KuemmelBreast Unit, Kliniken Essen-Mitte, Essen, Germany.ORCID 0000-0001-9355-494X
Toralf ReimerDepartment of Gynecology/Breast Unit, University Hospital Rostock, Rostock, Germany.ORCID 0000-0003-3014-370X
Markus HahnDepartment of Gynecology/Breast Unit, University Hospital Tuebingen, Tuebingen, Germany.
Marc ThillDepartment of Gynecology and Gynecological Oncology/Breast Unit, Agaplesion Markus Hospital Frankfurt, Frankfurt, Germany.ORCID 0000-0002-8800-8044
Jens-Uwe BlohmerCharité-Universitätsmedizin Berlin, Corporate Member of Freie Universität Berlin and Humboldt Universität zu Berlin, Department of Gynecology with Breast Center, Berlin, Germany.ORCID 0000-0002-7969-250X
John HackmannDepartment of Gynecology/Breast Unit, Marienhospital, Witten, Germany.
Wolfram MalterDepartment of Gynecology and Obstetrics, Breast Cancer Center, Medical Faculty, University of Cologne, Cologne, Germany.ORCID 0000-0002-5693-3120
Inga BekesDepartment of Gynecology/Breast Unit, University Hospital Ulm, Ulm, Germany.
Kay FriedrichsDepartment of Gynecology/Breast Unit, Jerusalem Hospital Hamburg, Hamburg, Germany.ORCID 0000-0003-0080-137X
Sebastian WojcinskiDepartment of Gynecology and Obstetrics, Breast Cancer Center, Klinikum Bielefeld Mitte GmbH, Bielefeld, Germany.ORCID 0000-0003-2713-3404
Sylvie JoosRadiologische Allianz Hamburg, Hamburg, Germany.
Stefan PaepkeDepartment of Gynecology/Breast Unit, Hospital rechts der Isar, Munich, Germany.
Tom DegenhardtDepartment of Gynecology/Breast Unit, University Hospital Munich, Munich, Germany.
Joachim RomDepartment of Gynecology/Breast Unit, Klinikum Frankfurt-Höchst, Frankfurt, Germany.ORCID 0000-0002-9738-5503
Achim RodyDepartment of Gynecology/Breast Unit, University Hospital Schleswig-Holstein, Luebeck, Germany.
Marion van MackelenberghDepartment of Gynecology/Breast Unit, University Hospital Schleswig-Holstein, Luebeck, Germany.ORCID 0000-0002-1084-5897
Maggie Banys-PaluchowskiDepartment of Gynecology/Breast Unit, University Hospital Schleswig-Holstein, Luebeck, Germany.
Regina GroßeDepartment of Gynecology/Breast Unit, University Hospital Halle, Halle, Germany.
Mattea ReinischBreast Unit, Kliniken Essen-Mitte, Essen, Germany.ORCID 0000-0002-1381-8595
Maria KarstenCharité-Universitätsmedizin Berlin, Corporate Member of Freie Universität Berlin and Humboldt Universität zu Berlin, Department of Gynecology with Breast Center, Berlin, Germany.
Michael GolattaUniversity Breast Unit, Department of Obstetrics & Gynecology, Heidelberg University Hospital, Heidelberg, Germany.ORCID 0000-0002-2605-0060
Joerg HeilUniversity Breast Unit, Department of Obstetrics & Gynecology, Heidelberg University Hospital, Heidelberg, Germany.ORCID 0000-0002-4684-9099
Heidelberg University · DEHumboldt-Universität zu Berlin · DEUniversity Hospital Schleswig-Holstein · DEKliniken Essen-Mitte · DEThe University of Texas MD Anderson Cancer Center · USAgaplesion Markus Hospital · DEKlinikum Bielefeld · DEKlinikum Frankfurt Höchst · DEKrankenhaus Jerusalem · DEMarien Hospital Witten · DEMünchen Klinik · DETUM Klinikum · DEUniversity Hospital in Halle · DEUniversity Hospital Ulm · DEUniversity of Cologne · DEUniversity of Rostock · DE

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

purposeNeoadjuvant systemic treatment (NST) elicits a pathologic complete response in 40%-70% of women with breast cancer. These patients may not need surgery as all local tumor has already been eradicated by NST. However, nonsurgical approaches, including imaging or vacuum-assisted biopsy (VAB), were not able to accurately identify patients without residual cancer in the breast or axilla. We evaluated the feasibility of a machine learning algorithm (intelligent VAB) to identify exceptional responders to NST.

methodsWe trained, tested, and validated a machine learning algorithm using patient, imaging, tumor, and VAB variables to detect residual cancer after NST (ypT+ or in situ or ypN+) before surgery. We used data from 318 women with cT1-3, cN0 or +, human epidermal growth factor receptor 2-positive, triple-negative, or high-proliferative Luminal B-like breast cancer who underwent VAB before surgery (ClinicalTrials.gov identifier: NCT02948764, RESPONDER trial). We used 10-fold cross-validation to train and test the algorithm, which was then externally validated using data of an independent trial (ClinicalTrials.gov identifier: NCT02575612). We compared findings with the histopathologic evaluation of the surgical specimen. We considered false-negative rate (FNR) and specificity to be the main outcomes.

resultsIn the development set (n = 318) and external validation set (n = 45), the intelligent VAB showed an FNR of 0.0%-5.2%, a specificity of 37.5%-40.0%, and an area under the receiver operating characteristic curve of 0.91-0.92 to detect residual cancer (ypT+ or in situ or ypN+) after NST. Spiegelhalter's Z confirmed a well-calibrated model (

conclusionAn intelligent VAB algorithm can reliably exclude residual cancer after NST. The omission of breast and axillary surgery for these exceptional responders may be evaluated in future trials.

Indexed as

Breast NeoplasmsNeoadjuvant TherapyAxillaFemaleHumansImage-Guided BiopsyNeoplasm, Residual

Identifiers

PMID35108029
OpenAlexW4210254969

What OpenQuestion holds

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.