Clinical Study on Adjuvant Therapy of TQB3616 Combined With Endocrine Therapy Compared With Placebo Combined With Endocrine Therapy in Patients With Breast Cancer
3. Blood clotting tests must meet the following criteria (no anticoagulant therapy):
1. Prothrombin time (PT) ≤ 1.5×ULN;
2. Activated partial thromboplastin time (APTT) ≤ 1.5×ULN;
3. International Normalized ratio (INR) ≤ 1.5×ULN.
4. Left ventricular ejection fraction (LVEF) ≥50%.
You may not be if
Complicated diseases and medical history:
1. Has had other malignant tumors within 5 years or currently has other malignant tumors;
2. Have a variety of factors that affect oral medication (such as inability to swallow);
3. Current history of serious lung disease such as interstitial pneumonia;
4. 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);
Known allergy to aromatase inhibitors, tamoxifen, TQB3616/ placebo, or any excipients;
There was a history of live attenuated vaccine vaccination within 28 days prior to randomization or live attenuated vaccine vaccination was planned during the study period;
Participated in clinical trials of other antitumor agents within 4 weeks prior to randomization;
The presence of other serious physical or mental illnesses or abnormalities in laboratory tests that may increase the risk of study participation or interfere with the study results, as well as subjects who are deemed unsuitable for study participation for other reasons by the investigator.
Clareo Health | Clinical Study on Adjuvant Therapy of TQB3616 Combined With Endocrine Therapy Compared With Placebo Combined With Endocrine Therapy in Patients With Breast Cancer