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

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexFemale
Age18+
SponsorFondazione IRCCS Istituto Nazionale dei Tumori, Milano

About this trial

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

Qualifiers

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.

Disqualifiers

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.

Trial design

Treatments tested in this trial

  • Omission of local therapies

Treatment groups

152 Participants
are divided into 2 treatment groups