Phase II Study of QL1706 with Anlotinib and Nab-Paclitaxel as First Treatment for Advanced Triple-Negative Breast Cancer

What this Trial Is About

Researchers are evaluating the combination of QL1706 with anlotinib hydrochloride and nab-paclitaxel as a first treatment for advanced triple-negative breast cancer in a phase II clinical trial. This study involves 34 participants who have not received prior systemic therapy for advanced disease and aims to assess the safety and effectiveness of this treatment approach. The trial is led by Jiangsu Cancer Institute & Hospital and focuses on patients with specific tumor characteristics confirmed by pathology. Participants receive QL1706 at 5 mgkg on day 1 every 3 weeks, anlotinib 12 mg daily from days 1 to 14 every 3 weeks, and nab-paclitaxel 125 mgm on days 1 and 8 every 3 weeks in 21-day cycles. Treatment continues until disease progression, unacceptable side effects, investigator decision, participant withdrawal, or up to 2 years. The study includes a screening period up to 28 days before treatment starts, followed by the treatment period and then a follow-up phase. During the study, participants undergo regular safety assessments every 3 weeks and tumor imaging every 6 weeks to monitor response. After stopping treatment, safety follow-up occurs about 30 days later, and survival status is tracked every 2 months by phone or other means. Participants provide samples and information at screening and during follow-up to support study evaluations. The main outcome measured is progression-free survival up to 36 months, with secondary outcomes including tumor response rate.

QUEEN-APPLE: A Single-Arm, Multicenter, Prospective Phase II Clinical Study of Iparomlimab and Tuvonralimab (QL1706) in Combination With Anlotinib Hydrochloride and Nab-Paclitaxel as First-Line Treatment for Advanced Triple-Negative Breast Cancer