Clinical trial · Interventional
Vabb After Neoadjuvant Therapy to Avoid Surgery-pCR to Avoid Breast Surgery
Non-inferiority Study in Patients With Complete Pathological Response After Neoadjuvant Chemotherapy and Negative VABB Biopsy Undergoing RT Alone, Omitting Surgical Treatment
- 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)
This single arm study aims to evaluate the efficacy and safety of a non-surgical approach, consisting of radiotherapy (RT) alone, for patients who have achieved a complete pathological response (pCR) following neoadjuvant chemotherapy (NACT). The study design involves the histological confirmation of pCR using vacuum-assisted biopsy (VABB) or vacuum-assisted excision (VAE) guided by ultrasound. The primary objective is to demonstrate that the non-surgical, RT-only treatment and follow-up approach is not inferior to the traditional surgical approach in patients with pCR after NACT.
Conditions
Conditions (4)
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 |
| HER2-positive Breast Cancer | HER2-Positive Breast Carcinoma | ALIAS | 0.90 |
| Neoadjuvant Chemotherapy | — | UNRESOLVED | — |
| Triple Negative Breast Cancer | Triple-Negative Breast Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Omission of surgical treatment | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Omission of surgical treatment
- description
- Omission of surgical treatment in patients with complete pathological response after neoadjuvant chemotherapy and negative VABB biopsy
- interventionNames
- Procedure: Omission of surgical treatment
Primary outcomes (1)
- measure
- Event-free survival
- timeFrame
- 5 years
- description
- Absence of disease recurrence or progression, second primary tumor, or death
Secondary outcomes (2)
- measure
- Positive predictive value of MRI
- timeFrame
- 6 months
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * age\> 18 years * infiltrating breast carcinoma, non-special histotype, triple negative or HER2 +, T1-T2 N0 * single lesion * neo-adjuvant chemotherapy treatment for at least 12 weeks according to clinical practice * conservative surgery proposal * M0 * tumour bed identified by breast markers placed in pre NACT by radiologist Exclusion Criteria: * Bilateral or multicentric tumour * Presence of microcalcifications visualised on mammography * Presence of associated DCIS * Positive history of previous breast cancer * Positive history of medical or psychiatric conditions preventing adherence to the protocol * High risk patient
References
Publications (0)
Data not yet available