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

RecruitingNAAges 18 Years - anyAllEuropean Institute of Oncology
NCT06281210 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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.

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📋 Eligibility rules (as published)
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
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What it tests

  • Omission of surgical treatment
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Where

2 sites
Istituto di Candiolo IRCCS
Candiolo, Italy
European Institute of Oncology
Milan, Italy
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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