NCT06938724RecruitingPhase 2
Omission of Local Therapies in Women Patients With HER2-positive or Triple-negative Breast Cancer
Omission of Local Therapies in Women Patients With HER2-positive or Triple-negative Breast Cancer: A Two Arm, Phase 2, Non-inferiority Trial for Surveillance in Maximum Responders to Neoadjuvant Systemic Therapy
Source: ClinicalTrials.gov · Last updated 15 Sept 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 152 (estimated)
- First submitted
- 7 Apr 2025
- Start date
- 25 Jul 2025
- Primary completion date
- 25 Jul 2035
- Lead sponsor
- Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
- Diseases
- Triple-negative breast cancer
- NCT number
- NCT06938724
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 152
- From 25 Jul 2025 to the primary completion date, 25 Jul 2035
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Residual ductal carcinoma in situ (DCIS) at VABB and/or surgery.
Other illness
- Bilateral synchronous breast cancer.
- Previous malignancy within 5 years.
Other
- One of the inclusion criteria missed.
- BRCA1-2, PALB2 or p53 proven mutation carrier (VUS are exclusion criteria as well).
- Patients unable to perform regular follow up.
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: Female · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Fondazione IRCCS Istituto Nazionale Tumori Milano Coordinator of this site? Confirm its status | Milan | Italy | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.