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NCT06281210: BETTY-CRASY

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

Recruiting now NA Last updated 28 February 2024
What this trial tests

NA trial testing Omission of surgical treatment in Breast Cancer in 77 participants. Currently enrolling.

Timeline
11 December 2023
Primary endpoint
31 December 2028
31 December 2028

Quick facts

Lead sponsorEuropean Institute of Oncology
PhaseNA
StatusRecruiting now
Study typeINTERVENTIONAL
Allocationna
Designsingle group
Maskingnone
Primary purposetreatment
Enrollment77
Start date11 December 2023
Primary completion31 December 2028
Estimated completion31 December 2028
Sites2 locations across Italy

Drugs / interventions tested

Conditions studied

Sponsor

European Institute of Oncology

Who can join

18 and older, any sex, with Breast Cancer or Triple Negative Breast Cancer. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.

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Other recruiting trials for Breast Cancer

Currently open trials in the same condition.

Other European Institute of Oncology trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT06281210.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing