Circulating Tumor Cells and Treatment De-escalation After Neoadjuvant Therapy for HER2 Positive Breast Cancer
Status:
Recruiting
Trial end date:
2028-04-30
Target enrollment:
Participant gender:
Summary
Phase II unicentric randomized trial which will include early HER2 positive breast cancer
patients, candidate to neoadjuvant therapy with trastuzumab and pertuzumab. Circulating tumor
cells will be collected at neoadjuvant therapy baseline.
Patients with pathological complete response will be randomized in 1:1 ratio for adjuvant
trastuzumab (arm A) versus trastuzumab + pertuzumab (arm B) in a two factorial design: group
A, with HER2 positive CTCs and group B, with HER2 negative/absent CTCs.