Fovinaciclib Plus Aromatase Inhibitors and Dual HER2 Blockade in a Response-Adapted Neoadjuvant Strategy for HR-Positive/HER2-Positive Early Breast Cancer (TAYLOR-003)
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.
• Female patients aged ≥18 years and ≤75 years. Histologically confirmed HR-positive (ER \>10%) and HER2-positive (IHC 3+ or IHC 2+/ISH+) early-stage or locally advanced invasive breast cancer.
• Pathologically staged as stage I-III according to the American Joint Committee on Cancer (AJCC) 8th edition staging system.
• Premenopausal patients must receive ovarian function suppression. Considered suitable for aromatase inhibitor treatment according to investigator assessment.
• Presence of evaluable disease according to RECIST version 1.1, including measurable and/or non-measurable lesions.
• Eastern Cooperative Oncology Group (ECOG) performance status score of 0-1. Ability to swallow capsules.
• Adequate bone marrow and organ function, defined as follows: