OncoMatch/Clinical Trials/NCT05780567
Clinical Study on Adjuvant Therapy of TQB3616 Combined With Endocrine Therapy Compared With Placebo Combined With Endocrine Therapy in Patients With Breast Cancer
Is NCT05780567 recruiting? Yes, currently enrolling (May 2026). This Phase 3 trial studies TQB3616 capsules, Letrozole, Anastrozole, Tamoxifen for breast cancer.
Treatment: TQB3616 capsules, Letrozole, Anastrozole, Tamoxifen — 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.
Check if I qualifyExtracted eligibility criteria
Cancer type
Breast Carcinoma
Biomarker criteria
Required: HER2 (ERBB2) negative
Required: ESR1 positive
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Must have received: surgery
Surgical treatment of radical mastectomy
Cannot have received: antitumor agent (clinical trial)
Participated in clinical trials of other antitumor agents within 4 weeks prior to randomization
Lab requirements
Blood counts
Hemoglobin ≥90 g/L; Neutrophil absolute value ≥ 1.5×10^9/L; Platelet count ≥ 100×10^9/L
Kidney function
Serum creatinine ≤ 1.5x ULN, or creatinine clearance (Ccr) ≥ 60 ml/min
Liver function
Total bilirubin (TBIL) ≤ 1.5x ULN; ALT and AST ≤ 1.5x ULN
Cardiac function
Left ventricular ejection fraction (LVEF) ≥50%
The major organs are functioning well, meeting the following criteria: ... Hemoglobin (HB) ≥90 g/L; Neutrophil absolute value (NEUT) ≥ 1.5×10^9/L; Platelet count (PLT) ≥ 100 ×10^9/L; Total bilirubin (TBIL) ≤ 1.5x ULN; ALT and AST ≤ 1.5x ULN; Serum creatinine ≤ 1.5x ULN, or creatinine clearance (Ccr) ≥ 60 ml/min; Prothrombin time (PT) ≤ 1.5x ULN; Activated partial thromboplastin time (APTT) ≤ 1.5x ULN; International Normalized ratio (INR) ≤ 1.5x ULN; Left ventricular ejection fraction (LVEF) ≥50%
Structured fields extracted by AI. May contain errors — verify against the official protocol.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualify