Status:
RECRUITING
Omission of Local Therapies in Women Patients With HER2-positive or Triple-negative Breast Cancer
Lead Sponsor:
Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
Conditions:
Breast Neoplasm Malignant Female
Eligibility:
FEMALE
18+ years
Phase:
PHASE2
Brief Summary
HER2-positive and Triple-negative are subtypes of breast cancer more sensitive to systemic therapies, where the complete pathological response rate may be higher than 50%. This gave rise to doubts abo...
Detailed Description
This is a prospective phase 2 non-randomized non-inferiority trial with two independent investigational arms. In each arm a 2-stage non-inferiority group-sequential design will be implemented; the ove...
Eligibility Criteria
Inclusion
- Women ≥ 18y.
- Initial diagnosis of unifocal HER2-positive (regardless of HR status) or Triple-negative (HR positivity lower than 10% is allowed) T1-2, N0-1, M0 breast cancer.
- Treated with neoadjuvant systemic treatment according to the center recommendations.
- Maximum responders and/or complete pathological response proved by surgery.
- Scheduled for breast conservation.
- Giving specific informed consent.
Exclusion
- One of the inclusion criteria missed.
- Residual ductal carcinoma in situ (DCIS) at VABB and/or surgery.
- Bilateral synchronous breast cancer.
- Previous malignancy within 5 years.
- BRCA1-2, PALB2 or p53 proven mutation carrier (VUS are exclusion criteria as well).
- Patients unable to perform regular follow up.
Key Trial Info
Start Date :
July 25 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 25 2035
Estimated Enrollment :
152 Patients enrolled
Trial Details
Trial ID
NCT06938724
Start Date
July 25 2025
End Date
July 25 2035
Last Update
September 15 2025
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Fondazione IRCCS Istituto Nazionale Tumori Milano
Milan, Italy, 20133