Omission of Local Therapies in Women Patients With HER2-positive or Triple-negative Breast Cancer
Recruiting
Phase 2
Interventional Study
Breast Neoplasm Malignant Female
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- 18 and older
- Sex
- Female
- Trial phase
- Phase 2
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 152 (estimated)
- Sponsor
- Fondazione IRCCS Istituto Nazionale dei Tumori, Milano · Other
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About This Trial
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 …
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
* 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 resp…
Contacts