Clinical trials / NCT06281210
Recruiting

Vabb After Neoadjuvant Therapy to Avoid Surgery-pCR to Avoid Breast Surgery

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…

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ClinicalTrials.gov IDNCT06281210
PhaseNA
Enrollment77
SponsorEuropean Institute of Oncology
Age18 Years and older
SexALL
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Conditions studied

Breast Cancer, Triple Negative Breast Cancer, HER2-positive Breast Cancer, Neoadjuvant Chemotherapy

About this study

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.

Interventions

Primary outcomes

Eligibility information

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

Study locations

Before you participate: Varda Clinical is an independent discovery tool, not the study sponsor or a medical provider. Eligibility can only be determined by the official study team. Discuss potential risks and benefits with a qualified healthcare professional.

Source: ClinicalTrials.gov. Record last refreshed by Varda Clinical: 2026-11-09.