Clinical trial · Interventional
Diagnosis of Pathological Complete Response by Minimal Invasive Biopsy After Neoadjuvant Chemotherapy in Breast Cancer
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
NCT02575612CI-TRIAL-00040926completedN/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 study aims to evaluate the ability of representative vacuum-assisted minimal invasive biopsy (VAB) to diagnose pathological complete response (pCR=ypT0) in breast cancer patients after neoadjuvant chemotherapy (NACT).
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 | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- vacuum-assisted biopy
- description
- All patients enrolled in this study received a vacuum-assisted biopsy before surgery.
- interventionNames
- Procedure: vacuum-assisted biopsy
Primary outcomes (1)
- measure
- false negative rate to diagnose a pathological complete response by vacuum-assisted biopsy for the whole cohort and predefined subgroups
- timeFrame
- 1 week
- description
- As an explorative study, the statistical analysis was performed using descriptive methods only. For a baseline comparison between groups, the investigators compared the group of patients with pCR to the group of patients without pCR. As primary outcomes the investigators calculated negative predictive values (NPV) and false negative rates (FNR) for the whole study cohort as well as for certain subgroups (especially addressing the question of evaluating representativeness of VAB). The investigators calculated two-sided-95% confidence intervals for all results.
Secondary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: The investigators included patients * after neoadjuvant chemotherapy (NACT) according to the NACT protocol * with at least one detectable mass / marker after NACT in ultrasound * with cT1c-cT4a-c tumors * after informed consent * with unilateral or bilateral primary breast cancer, confirmed histologically prior to chemotherapy * with known grading, ER/PgR/HER-2neu- and Ki-67 status * with breast ultrasound, mammography (and breast MRI where necessary) before and after NACT * clinical / imaging partial or complete response to NACT Exclusion Criteria: The investigators excluded patients from the study with * NACT \<12 weeks because of termination due to progressive disease, massive adverse events or patient wish * non-detectable mass in ultrasound / dislocation of marker (\> 10mm distance to the initial lesion) * cT4d stage (inflammatory breast cancer) * M1 stages * stable disease according to a multimodal assessment of ultrasound, mammography and breast MRI (if available) according to RECIST
References
Publications (2)
- 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