Actively Recruiting
Vabb After Neoadjuvant Therapy to Avoid Surgery-pCR to Avoid Breast Surgery
Led by European Institute of Oncology · Updated on 2024-02-28
77
Participants Needed
2
Research Sites
263 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Vabb After Neoadjuvant Therapy to Avoid Surgery-pCR to Avoid Breast Surgery
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age greater than 18 years
- Diagnosed with infiltrating breast carcinoma, non-special histotype, triple negative or HER2-positive, stage T1-T2 N0
- Presence of a single lesion
- Completed at least 12 weeks of neoadjuvant chemotherapy according to clinical practice
- Eligible for conservative surgery
- No distant metastasis (M0)
- Tumor bed identified by breast markers placed before neoadjuvant chemotherapy by a radiologist
You will not qualify if you...
- Bilateral or multicentric tumor
- Presence of microcalcifications seen on mammography
- Presence of associated ductal carcinoma in situ (DCIS)
- History of previous breast cancer
- History of medical or psychiatric conditions that prevent adherence to the study protocol
- Classified as a high-risk patient
AI-Screening
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Trial Site Locations
Total: 2 locations
1
Istituto di Candiolo IRCCS
Candiolo, Turin, Italy, 10060
Not Yet Recruiting
2
European Institute of Oncology
Milan, Italy, 20141
Actively Recruiting
Research Team
E
Elisabetta Rossi, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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