RecruitingPhase 2NCT06938724

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

Sponsor

Fondazione IRCCS Istituto Nazionale dei Tumori, Milano

Enrollment

152 participants

Start Date

Jul 25, 2025

Study Type

INTERVENTIONAL

Conditions

Breast Neoplasm Malignant Female

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

Sex: FEMALEMin Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is exploring whether women with certain types of breast cancer who had a complete response to pre-surgery chemotherapy (meaning no cancer was found at surgery) can safely skip radiation therapy and further local treatment. The focus is on HER2-positive or triple-negative breast cancer that fully responded to treatment. **You may be eligible if...** - You are a woman 18 or older - You were diagnosed with HER2-positive or triple-negative early breast cancer (stage T1-T2, N0-N1, M0) - You received pre-surgery (neoadjuvant) chemotherapy and had a complete or near-complete response - You are scheduled for breast-conserving surgery **You may NOT be eligible if...** - You have cancer remaining in the breast ducts (DCIS) found at biopsy or surgery - You have cancer in both breasts at the same time - You have had another cancer in the last 5 years - You carry a BRCA1, BRCA2, PALB2, or p53 gene mutation - You are unable to complete regular follow-up appointments Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

OTHEROmission of local therapies

Omission of surgery (arm A) or radiotherapy (arm B) in those patients who have had the maximum response by neoadjuvant treatments. Maximum responders are those patients with no evidence of residual disease after neoadjuvant treatment at imaging -including mammography, US evaluation and contrast imaging procedures (MRI and/or CEM)-, confirmed by VABB on marked site of ascertained lesion. This study is open to all patients with T1-2, N0-1, M0 HER2-positive or triple negative breast cancer, treated with neoadjuvant systemic treatment, irrespective of treatments delivered.

Locations(1)

Fondazione IRCCS Istituto Nazionale Tumori Milano

Milan, Italy

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NCT06938724

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