Fovinaciclib Plus Aromatase Inhibitors and Dual HER2 Blockade in a Response-Adapted Neoadjuvant Strategy for HR-Positive/HER2-Positive Early Breast Cancer

This prospective, response-adapted phase II study evaluates the efficacy and safety of neoadjuvant fovinaciclib in combination with aromatase inhibitors and dual HER2 blockade in patients with HR-positive/HER2-positive early breast cancer. All patients initially receive induction treatment with fovinaciclib plus endocrine therapy and HER2-targeted therapy, followed by early assessment of treatment response after 6 weeks of treatment. Patients demonstrating an adequate response continue the same regimen, whereas those with a suboptimal response are transitioned to standard neoadjuvant chemotherapy combined with HER2-targeted therapy prior to surgery. This adaptive approach aims to optimize treatment selection, improve therapeutic efficacy, and reduce unnecessary chemotherapy exposure.

NCT Number	NCT07616427
Lead Sponsor	Second Affiliated Hospital, School of Medicine, Zhejiang University
Conditions	HR+/HER2+ Early Breast Cancer
Enrollment	100 participants
Start Date	2026-05-20
Primary Completion	2028-05-20 (estimated)
Study Completion	2033-05-20 (estimated)
Updated on ClinicalTrials.gov	2026-06-01