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 to the traditional surgical approach in patients with pCR after NACT.

Trial Details

NCT ID
NCT06281210
Phase
NA
Sponsor
European Institute of Oncology
Status
RECRUITING
Cancer Type
Breast Cancer
Interventions
  • Omission of surgical treatment
Locations (sample)
  • Candiolo, Turin, Italy|44.95858,7.59812
  • Milan, Italy|45.46427,9.18951

Key Eligibility 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

For full eligibility, visit ClinicalTrials.gov.

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