Skipping surgery or radiotherapy for some women with HER2-positive or triple-negative early breast cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a phase 2, prospective, non-randomized non-inferiority trial with two parallel arms testing omission of local therapies in highly selected responders to neoadjuvant systemic treatment. Each arm uses a two-stage group-sequential design with 76 patients per arm and an interim futility analysis after 43 patients reviewed by an independent DSMC. Arm A will offer omission of surgery in unifocal T1-2 N0 M0 patients demonstrating maximal response (managed with whole-breast irradiation only), while Arm B will offer omission of radiotherapy for patients with confirmed complete pathological response after conservative surgery. The trial enrolls adult women with unifocal HER2-positive or triple-negative T1-2 N0-1 M0 breast cancer treated at a single Italian cancer center.

Why it matters

Who can join: the full rules

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.

Where it's running

• Fondazione IRCCS Istituto Nazionale Tumori Milano
  Milan, Italy Recruiting

Study contacts

• Principal investigator: Massimiliano Gennaro, MD — Fondazione IRCCS Istituto Nazionale Tumori Milan
• Study coordinator: Massimiliano Gennaro, MD
• Email: massimiliano.gennaro@istitutotumori.mi.it
• Phone: +390223903246

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.