Clinical trial · Observational
Histology VABB-Histology Post Surgery Pilot Project (BETTY Trial)
Comparison Between Histological VABB and Histological Post-surgery in Patient With Complete Pathological Response After Neoadjuvant Systemic Treatment: Pilot Study
- 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)
Pilot study on patients with invasive ductal breast cancer triple negative or receptor tyrosine-protein kinase erbB-2 (HER2) overexpressed, any axillary lymphnodes status (any cN), candidates to neoadjuvant chemotherapy. The principal endpoint of the study will be the accuracy of the result of the histological examination of the Vacuum- Assisted Breast Biopsy (VABB) performed pre-surgery in comparison to the result of the histological examination of the definitive surgical intervention in patients with radiological complete response at Magnetic resonance imaging (MRI) done after the end of neoadjuvant chemotherapy.
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 Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| vacuum-assisted breast biopsy | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- patient with radiological complete response
- description
- patient with radiological complete response after neoadjuvant chemotherapy
- interventionNames
- Procedure: vacuum-assisted breast biopsy
Primary outcomes (1)
- measure
- Evaluation of the accuracy of histological examination of the VABB performed pre-surgery
- timeFrame
- 45 days
- description
- Identification of percentage of cases with correspondence between histology of VABB presurgery and histology of definitive surgery in patients with complete radiological response after neoadjuvant chemotherapy
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 99 Years
Show eligibility criteria text
Inclusion Criteria: * age ≥ 18 aa; * histological diagnosis done at European Institute of Oncology (if not, to does revision of pathological material); * invasive ductal breast cancer triple negative or HER2 overexpressed, any cN; * neoadjuvant standard systemic treatment after surgery +/- trastuzumab; * propose of conservative or demolitive surgery; * M0 * cancer bed identified pre neoadjuvant chemotherapy by clip Exclusion Criteria: * multicentric or bilateral breast cancer * mammography microcalcifications * in situ breast carcinoma * positive anamnesis for previous breast cancer * positive anamnesis for medical or psychological conditions that prevent membership study
References
Publications (0)
Data not yet available