NCT06938724 Omission of Local Therapies in Women Patients With HER2-positive or Triple-negative Breast Cancer
| NCT ID | NCT06938724 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Fondazione IRCCS Istituto Nazionale dei Tumori, Milano |
| Condition | Breast Neoplasm Malignant Female |
| Study Type | INTERVENTIONAL |
| Enrollment | 152 participants |
| Start Date | 2025-07-25 |
| Primary Completion | 2035-07-25 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 152 participants in total. It began in 2025-07-25 with a primary completion date of 2035-07-25.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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 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.
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 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.
Contact & Investigator
Massimiliano Gennaro, MD
PRINCIPAL INVESTIGATOR
Fondazione IRCCS Istituto Nazionale Tumori Milan
Frequently Asked Questions
Who can join the NCT06938724 clinical trial?
This trial is open to female participants only, aged 18 Years or older, studying Breast Neoplasm Malignant Female. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06938724 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT06938724 currently recruiting?
Yes, NCT06938724 is actively recruiting participants. Contact the research team at massimiliano.gennaro@istitutotumori.mi.it for enrollment information.
Where is the NCT06938724 trial being conducted?
This trial is being conducted at Milan, Italy.
Who is sponsoring the NCT06938724 clinical trial?
NCT06938724 is sponsored by Fondazione IRCCS Istituto Nazionale dei Tumori, Milano. The principal investigator is Massimiliano Gennaro, MD at Fondazione IRCCS Istituto Nazionale Tumori Milan. The trial plans to enroll 152 participants.