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Omission of Local Therapies in Women Patients With HER2-positive or Triple-negative Breast Cancer

RecruitingPhase 2Ages 18 Years - anyFemaleFondazione IRCCS Istituto Nazionale dei Tumori, M…
NCT06938724 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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.

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📋 Eligibility rules (as published)
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 responders and/or complete pathological response proved by surgery. * Scheduled for breast conservation. * Giving specific informed consent. Exclusion Criteria: * 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.
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What it tests

  • Omission of local therapies
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Where

1 site
Fondazione IRCCS Istituto Nazionale Tumori Milano
Milan, Italy
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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