Clinical Study on Adjuvant Therapy of TQB3616 Combined With Endocrine Therapy Compared With Placebo Combined With Endocrine Therapy in Patients With Breast Cancer
NCT ID: NCT05780567
Last Updated: 2023-04-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
RECRUITING
PHASE3
1946 participants
INTERVENTIONAL
2023-03-30
2027-01-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
CDK4/6 Inhibitors Combined With Standard Adjuvant Endocrine Therapy in High-Risk, HR+/HER2+ Early Breast Cancer Patients
NCT07019363
Epirubicin and Tamoxifen With or Without Docetaxel in Treating Postmenopausal Women With Breast Cancer
NCT00010140
Tamoxifen in Treating Women With Breast Cancer
NCT00003678
Efficacy of Tamoxifen Versus Toremifene in CYP2D6 IM/PM of Premenopausal Patients With ER-positive Early Breast Cancer
NCT03351062
S1207 Hormone Therapy With or Without Everolimus in Treating Patients With Breast Cancer
NCT01674140
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
TQB3616 capsules combined with endocrine
The dose of TQB3616 capsules is 180mg, taken orally when fasting, once a day for 28 consecutive days as one treatment cycle.
The dose of Letrozole is 2.5mg, taken orally, once a day for 28 consecutive days as one treatment cycle.
The dose of Anastrozole is 1mg, taken orally, once a day for 28 consecutive days as one treatment cycle.
The dose of Tamoxifen is 10mg, taken orally, twice a day for 28 consecutive days as one treatment cycle.
TQB3616 capsules, Letrozole, Anastrozole, Tamoxifen
TQB3616 is a novel Cyclin-dependent kinase (CDK) 4/6 inhibitor and currently being used in the treatment of a variety of malignant solid tumors.
Letrozole combined with Anastrozole and Tamoxifen is an endocrine therapy that involves adding, blocking, or removing hormones. It can be used for conditions that affect hormone levels, such as breast cancer.
placebo combined with endocrine
The dose of placebo is 180mg, taken orally when fasting, once a day for 28 consecutive days as one treatment cycle.
The dose of Letrozole is 2.5mg, taken orally, once a day for 28 consecutive days as one treatment cycle.
The dose of Anastrozole is 1mg, taken orally, once a day for 28 consecutive days as one treatment cycle.
The dose of Tamoxifen is 10mg, taken orally, twice a day for 28 consecutive days as one treatment cycle.
Placebo capsules, Letrozole, Anastrozole, Tamoxifen
Letrozole combined with Anastrozole and Tamoxifen is an endocrine therapy that involves adding, blocking, or removing hormones. It can be used for conditions that affect hormone levels, such as breast cancer.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
TQB3616 capsules, Letrozole, Anastrozole, Tamoxifen
TQB3616 is a novel Cyclin-dependent kinase (CDK) 4/6 inhibitor and currently being used in the treatment of a variety of malignant solid tumors.
Letrozole combined with Anastrozole and Tamoxifen is an endocrine therapy that involves adding, blocking, or removing hormones. It can be used for conditions that affect hormone levels, such as breast cancer.
Placebo capsules, Letrozole, Anastrozole, Tamoxifen
Letrozole combined with Anastrozole and Tamoxifen is an endocrine therapy that involves adding, blocking, or removing hormones. It can be used for conditions that affect hormone levels, such as breast cancer.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
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.
18 Years
75 Years
FEMALE
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Cancer Hospital Chinese Academy of Medical Science
Beijing, Beijing Municipality, China
Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University
Guangzhou, Guangdong, China
Suining Central Hospital
Suining, Sichuan, China
Countries
Review the countries where the study has at least one active or historical site.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
TQB3616-III-03
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.