Clinical Study on Adjuvant Therapy of TQB3616 Combined With Endocrine Therapy Compared With Place… (NCT05780567) | Clinical Trial Compass
Active — Not RecruitingPhase 3
Clinical Study on Adjuvant Therapy of TQB3616 Combined With Endocrine Therapy Compared With Placebo Combined With Endocrine Therapy in Patients With Breast Cancer
China1,946 participantsStarted 2023-03-30
Plain-language summary
This is a Phase III, randomized, double-blind, parallel, multi-center trail to evaluate the efficacy and safety of TQB3616 capsule combined with endocrine compared to placebo compared with endocrine in HR-positive and HER2-negative breast cancer adjuvant therapy. Approximately 1946 female subjects will be randomized to either TQB3616 combined with endocrine group or TQB3616-matching placebo combined endocrine group. Randomization will follow a 2:1 ratio, 1297 subjects in experimental group and 649 in the the Placebo Comparator group.
Who can participate
Age range18 Years – 75 Years
SexFEMALE
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Inclusion criteria
✓. Blood biochemical tests should meet the following criteria (no corrective therapy has been used within 7 days prior to screening)：
✓. Hemoglobin (HB) ≥90 g/L；
✓. Neutrophil absolute value (NEUT) ≥ 1.5×109/L；
✓. Platelet count (PLT) ≥ 100 ×109/L；
✓. Blood biochemical tests should meet the following criteria (no corrective therapy has been used within 7 days prior to screening)：
✓. Total bilirubin (TBIL) ≤ 1.5 times the upper limit of normal (ULN)；
✓. Alanine transferase (ALT) and aspartate transferase (AST) ≤ 1.5×ULN；
. Have a variety of factors that affect oral medication (such as inability to swallow);
✕. Current history of serious lung disease such as interstitial pneumonia；
✕. Severe infections common terminology criteria for adverse events (≥CTCAE (common terminology criteria for adverse events) 2 grade) that were active or uncontrolled before the study treatment started (Except hair loss and hemoglobin)；