This study is a randomized, open-label, controlled, multicenter Phase II trial conducted in patients with advanced HER2-positive breast cancer, aimed at evaluating the efficacy and safety of paclitaxel polymer micelles for injection combined with trastuzumab and adalimumab versus the paclitaxel-based regimen combined with trastuzumab as first-line treatment.
Eligible subjects with histologically or cytologically confirmed advanced HER2-positive breast cancer were enrolled after obtaining informed consent. They were randomly assigned to two groups: the experimental group received paclitaxel polymer micelles for injection combined with trastuzumab, pertuzumab, and adrelumab; the control group received taxanes (paclitaxel, docetaxel, albumin-bound paclitaxel, paclitaxel polymer micelles) combined with trastuzumab and pertuzumab. Each treatment cycle lasted 3 weeks (Q3W), with administration on day 1 (D1) of each cycle. Therapy continued until disease progression (PD), intolerable toxicity, withdrawal of informed consent, initiation of alternative antitumor therapy, death, or any other treatment discontinuation criteria specified in the protocol-whichever occurred first.