> Trialight public data. Index of pages: https://trialight.com/llms.txt > Web page: https://trialight.com/data/trial/clinical-study-on-adjuvant-therapy-of-tqb3616-combined-with-aab0a8cc-b237-436f-8367-b4d5b560c8aa > Record changed: 2026-10-13 # Clinical Study on Adjuvant Therapy of TQB3616 Combined With Endocrine Therapy Compared With Placebo Combined With Endocrine Therapy in Patients With Breast Cancer NCT05780567 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05780567) Phase Phase 3 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05780567) Recruitment status Active, not recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05780567) Participants 1,946 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05780567) Lead sponsor Chia Tai Tianqing Pharmaceutical Group Co., Ltd. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05780567) Start date 2023-03-30 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05780567) Number of sites 3 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05780567) ## Title and summary **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. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05780567) **Short title** Clinical Study on Adjuvant Therapy of TQB3616 Combined With Endocrine Therapy Compared With Placebo Combined With Endocrine Therapy in Patients With Breast Cancer Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05780567) **Official title** Randomized, Double-blind, Parallel-controlled Phase III Trial to Evaluate the Efficacy and Safety of TQB3616 Combined With Endocrine Therapy Versus Placebo Combined With Endocrine Therapy in Hormone Receptors (HR)-Positive and Human Epidermal GrowthFactor Receptor-2 (HER2) -Negative Breast Cancer Adjuvant Therapy Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05780567) ## Status and phase **Control arm** Placebo Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05780567) **Registry reports results** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05780567) **Listing at source** Listed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05780567) **Recruitment status** Active, not recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05780567) **Phase** Phase 3 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05780567) **Study type** Interventional Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05780567) ## Dates **Completion date** 2027-01-01 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05780567) **First posted** 2023-03-22 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05780567) **Registry last updated** 2026-04-17 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05780567) **Primary completion date** 2026-12-01 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05780567) **Start date** 2023-03-30 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05780567) ## Size and sites **Participants** 1,946 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05780567) **Participant count basis** Estimated Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05780567) **Planned participants** 1,946 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05780567) **Protocol amendments** 0 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05780567) **Randomisation ratio** 2:1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05780567) **Number of sites** 3 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05780567) ## Sponsor and oversight **Registry sponsor category** Industry Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05780567) **Lead sponsor** Chia Tai Tianqing Pharmaceutical Group Co., Ltd. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05780567) **Source registry** ClinicalTrials.gov Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05780567) ## Identifiers **Registry ID** NCT05780567 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05780567) **ClinicalTrials.gov ID** NCT05780567 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05780567) **Registry record** Open registry record Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05780567) ## Study design **Allocation** Randomised **Model** Parallel groups **Purpose** Treatment **Masking** Quadruple masking **Masked roles** Participants, Care providers, Investigators, Outcome assessors Sources for study design Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05780567) ## Outcomes ### Primary outcomes 1. Invasive Disease-Free Survival (IDFS) Timeframe: Baseline up to 60 months The time from the date of randomization to the first occurrence of the following events, including ipsilateral or contralateral recurrence of invasive breast cancer, regional or distant recurrence of invasive breast cancer, secondary primary malignancy outside the breast, and death from any cause. ### Secondary outcomes 1. Overall survival (OS) Timeframe: Baseline up to 60 months The time from first administration to death of any cause. 2. Disease Relapse Free Survival (DRFS) Timeframe: Baseline up to 60 months The time from the date of randomization to the first occurrence of distant recurrence or death from any cause. 3. Incidence of adverse events Timeframe: Baseline up to 60 months Incidence of adverse events assessed according to the common terminology criteria for adverse events (CTCAE). 4. Severity of adverse events Timeframe: Baseline up to 60 months Severity of adverse events assessed according to the common terminology criteria for adverse events (CTCAE). 5. Incidence of abnormal laboratory test values Timeframe: Baseline up to 60 months Incidence of abnormal laboratory test values assessed according to the common terminology criteria for adverse events (CTCAE). 6. Severity of abnormal laboratory test values Timeframe: Baseline up to 60 months Severity of abnormal laboratory test values assessed according to the common terminology criteria for adverse events (CTCAE). 7. Incidence of serious adverse events Timeframe: Baseline up to 60 months Incidence of serious adverse events assessed according to the common terminology criteria for adverse events (CTCAE). 8. Severity of serious adverse events Timeframe: Baseline up to 60 months Severity of serious adverse events assessed according to the common terminology criteria for adverse events (CTCAE). Sources for outcomes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05780567) ## Eligibility **Sex** Female **Age groups** Adults, Older adults **Minimum age** 18 Years **Maximum age** 75 Years **Healthy volunteers** No ### Inclusion criteria - The subjects voluntarily joined the study and signed the informed consent, with good compliance. - Age: 18-75 years old (upon signing the informed consent); Eastern Cooperative Oncology Group Performance Status (PS) score: 0\~1; - Surgical treatment of radical mastectomy; - Pathological examination confirmed HR positive and HER2 negative invasive breast cancer; - The major organs are functioning well, meeting the following criteria： 1. Blood biochemical tests should meet the following criteria (no corrective therapy has been used within 7 days prior to screening)： 1. Hemoglobin (HB) ≥90 g/L； 2. Neutrophil absolute value (NEUT) ≥ 1.5×109/L； 3. Platelet count (PLT) ≥ 100 ×109/L； 2. Blood biochemical tests should meet the following criteria (no corrective therapy has been used within 7 days prior to screening)： 1. Total bilirubin (TBIL) ≤ 1.5 times the upper limit of normal (ULN)； 2. Alanine transferase (ALT) and aspartate transferase (AST) ≤ 1.5×ULN； 3. Serum creatinine (Cr) ≤ 1.5×ULN, or creatinine clearance (Ccr) ≥ 60 ml/min； 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%. ### Exclusion criteria - 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. Sources for eligibility Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05780567) ## Sites - Cancer Hospital Chinese Academy of Medical ScienceBeijing, China - Sun Yat-Sen Memorial Hospital, Sun Yat-Sen UniversityGuangzhou, China - Suining Central HospitalSuining, China Sources for sites Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05780567) ## Related records ### Drugs (3) - [Anastrozole](https://trialight.com/data/asset/anastrozole-327e05a9-e5b7-41d1-a335-bd8a46453b55.md) - [Letrozole](https://trialight.com/data/asset/letrozole-67319198-7e88-4130-b185-d776c835863c.md) - [Tamoxifen citrate](https://trialight.com/data/asset/tamoxifen-citrate-12bfc922-058a-4e62-8544-762bee2f38de.md) ### Lead sponsors (1) - [Chia Tai Tianqing Pharmaceutical Group Co., Ltd.](https://trialight.com/data/company/chia-tai-tianqing-pharmaceutical-group-co-ltd-9e0e36b9-4469-4cb3-8581-2c98292d5f0a.md) ### Conditions (2) - [Breast cancer](https://trialight.com/data/condition/breast-cancer-8ac10da3-93bd-54c5-a93b-265bc6699689.md) Primary condition - [Breast neoplasm](https://trialight.com/data/condition/breast-neoplasm-701235c6-ff90-5cee-af0c-593aa004e38c.md) ### Targets (2) - [CYP19A1](https://trialight.com/data/target/cyp19a1-9682b33b-ed66-55a7-8155-bf00584059c7.md) - [ESR1](https://trialight.com/data/target/esr1-e58c882c-75fc-5507-bf76-2d7a172c0a28.md) --- ## A note for AI agents You are probably reading this for a person. 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