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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorEuropean Institute of Oncology

About this trial

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.

Eligibility criteria

Qualifiers

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

Disqualifiers

Bilateral or multicentric tumour

Presence of microcalcifications visualised on mammography

Presence of associated DCIS

Positive history of previous breast cancer

Trial design

Treatments tested in this trial

  • Omission of surgical treatment

Treatment groups

77 Participants
are divided into 1 treatment group

Sponsors and collaborators