Actively Recruiting
Omission of Local Therapies in Women Patients With HER2-positive or Triple-negative Breast Cancer
Led by Fondazione IRCCS Istituto Nazionale dei Tumori, Milano · Updated on 2025-09-15
152
Participants Needed
1
Research Sites
521 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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 about the usefulness of traditional local treatments for such responders. Omission of surgery after vacuum assisted breast biopsy (VABB) as well omission of radiotherapy after conservative surgery would now seem to be reasonable alternatives to standard care for highly selected patients, in whom systemic treatments have provided the maximum response.
CONDITIONS
Official Title
Omission of Local Therapies in Women Patients With HER2-positive or Triple-negative Breast Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Women aged 18 years or older
- Initial diagnosis of unifocal HER2-positive (any hormone receptor status) or Triple-negative breast cancer with hormone receptor positivity below 10%
- Clinical stage T1-2, N0-1, M0 breast cancer
- Treated with neoadjuvant systemic therapy as recommended by the treatment center
- Maximum response to therapy and/or complete pathological response confirmed by surgery
- Scheduled for breast-conserving surgery
- Provided specific informed consent
You will not qualify if you...
- Missing any of the inclusion criteria
- Presence of residual ductal carcinoma in situ (DCIS) at biopsy or surgery
- Bilateral synchronous breast cancer
- History of another malignancy within the past 5 years
- Known mutation carrier of BRCA1, BRCA2, PALB2, or p53 (including variants of uncertain significance)
- Unable to participate in regular follow-up
AI-Screening
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Trial Site Locations
Total: 1 location
1
Fondazione IRCCS Istituto Nazionale Tumori Milano
Milan, Italy, 20133
Actively Recruiting
Research Team
M
Massimiliano Gennaro, MD
CONTACT
K
Kiara Muca
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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