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

This study is a single-arm, multicenter, prospective phase II clinical trial designed to evaluate the efficacy and safety of QL1706 in combination with anlotinib hydrochloride and nab-paclitaxel as first-line treatment for advanced triple-negative breast cancer. A total of 34 participants with first-line advanced triple-negative breast cancer are enrolled in this study: Enrolled participants receive QL1706 (5 mg/kg, Q3W, day 1) + anlotinib (12 mg per dose, QD, days 1-14, Q3W) + nab-paclitaxel (125 mg/m², days 1 and 8, Q3W), with a 21-day cycle. Treatment continues until disease progression,

Trial Details

NCT ID
NCT07601178
Phase
PHASE2
Sponsor
Jiangsu Cancer Institute & Hospital
Status
RECRUITING
Cancer Type
Triple Negative (TNBC) Breast Cancer
Interventions
  • TREATMENT GROUP（QL1706 + anlotinib+ nab-paclitaxel ）
Locations (sample)
  • Nanjing, Jiangsu, China|32.06167,118.77778

Key Eligibility Criteria

  • Participants voluntarily join the study, sign the informed consent form, and agree to strictly comply with the study protocol requirements.
  • Female patients aged between 18 and 75 years.
  • Confirmed by histopathological examination as advanced triple-negative invasive breast cancer, meeting the following criteria: pathological type tr…
  • TNBC patients with initial diagnosis of stage IV (according to AJCC 8th edition) or recurrent/metastatic disease who are not suitable for surgery, …

For full eligibility, visit ClinicalTrials.gov.

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