Omission of Local Therapies in Women Patients With HER2-positive or Triple-negative Breast Cancer
Recruiting now · Phase 2
Conditions studied: Breast Neoplasm Malignant Female
In brief
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.
Key facts
- Study ID
- NCT06938724
- Run by
- Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
- People needed
- 152
- Starts
- 2025-07-25
- Expected to finish
- 2035-07-25
- Last updated by the study team
- 2025-09-15
Who can join
Age: 18 and older. Sex: female. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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.
Where it is running
- Fondazione IRCCS Istituto Nazionale Tumori Milano — Milan, Italy (enrolling)
Full record on ClinicalTrials.gov
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