RecruitingNot ApplicableNCT06281210

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

Non-inferiority Study in Patients With Complete Pathological Response After Neoadjuvant Chemotherapy and Negative VABB Biopsy Undergoing RT Alone, Omitting Surgical Treatment


Sponsor

European Institute of Oncology

Enrollment

77 participants

Start Date

Dec 11, 2023

Study Type

INTERVENTIONAL

Conditions

Summary

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This trial is exploring whether patients with early-stage breast cancer who have a complete response (no remaining cancer cells) after chemotherapy given before surgery might be able to skip the surgery altogether. Researchers use a vacuum-assisted biopsy device (VABB) to check for remaining cancer at the original tumor site. **You may be eligible if...** - You are over 18 years old - You have a single breast tumor (non-special type) that is HER2-positive or triple-negative, classified as T1 or T2 with no lymph node spread (N0) - You have received at least 12 weeks of neoadjuvant (pre-surgery) chemotherapy - You were a candidate for breast-conserving surgery - A marker was placed in the tumor before chemotherapy to track the tumor bed **You may NOT be eligible if...** - Your cancer involves both breasts or multiple areas - You have microcalcifications visible on mammogram - You have DCIS (ductal carcinoma in situ) alongside your cancer - You have a history of previous breast cancer - You have a medical or psychiatric condition that prevents protocol adherence Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

PROCEDUREOmission of surgical treatment

Omission of surgery in patients with pCR after neoadjuvant chemotherapy and negative VABB biopsy


Locations(2)

Istituto di Candiolo IRCCS

Candiolo, Turin, Italy

European Institute of Oncology

Milan, Italy

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NCT06281210


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