To Evaluate the Efficacy and Safety of TQB3616 in Combination With Fulvestrant Versus Placebo in Combination With Fulvestrant in Previously Untreated Hormone-receptor (HR)-Positive, Human Epidermal Growth Factor Receptor 2 (HER2)-Negative Advanced Breast Cancer
NCT ID: NCT05365178
Last Updated: 2026-01-07
Study Results
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Basic Information
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ACTIVE_NOT_RECRUITING
PHASE3
432 participants
INTERVENTIONAL
2022-07-01
2026-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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TQB3616 capsule + Fulvestrant injection
TQB3616 capsule:
180mg was given orally with meals or within 2 hours after meals, once a day， every 28 days for a cycle.
Fulvestrant injection:
500mg intramuscular injection was administered on day 1, every 28 days for a cycle, for the first cycle, was administered on day 1 and day 15
TQB3616 capsule
TQB3616 capsule is a CDK (cyclin-dependent kinases) 2/4/6 kinase inhibitor, which can selectively inhibit THE activity of CDK2/4/6 kinase, make it form a complex with Cyclin D, reduce the phosphorylation level of retinoblastoma protein (Rb) in cancer cells, and prevent cells from entering S phase from G1 phase
Fulvestrant injection
Fulvestrant is a competitive estrogen receptor antagonist, and its mechanism is related to the down-regulation of estrogen receptor (ER) protein level
Placebo capsule + Fulvestrant injection
Placebo capsules:
0mg was given orally with meals or within 2 hours after meals, once a day, every 28 days for a cycle.
Fulvestrant injection:
500mg intramuscular injection was administered on day 1, every 28 days for a cycle, for the first cycle, was administered on day 1 and day 15
Placebo
It is a placebo
Fulvestrant injection
Fulvestrant is a competitive estrogen receptor antagonist, and its mechanism is related to the down-regulation of estrogen receptor (ER) protein level
Interventions
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TQB3616 capsule
TQB3616 capsule is a CDK (cyclin-dependent kinases) 2/4/6 kinase inhibitor, which can selectively inhibit THE activity of CDK2/4/6 kinase, make it form a complex with Cyclin D, reduce the phosphorylation level of retinoblastoma protein (Rb) in cancer cells, and prevent cells from entering S phase from G1 phase
Placebo
It is a placebo
Fulvestrant injection
Fulvestrant is a competitive estrogen receptor antagonist, and its mechanism is related to the down-regulation of estrogen receptor (ER) protein level
Eligibility Criteria
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Inclusion Criteria
* Age: 18-75 years (when signing the informed consent); an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1; Is expected to survive more than 3 months;
* Postmenopausal or premenopausal/perimenopausal women；
* Patients with HR-positive or HER2-negative breast cancer confirmed by pathological examination with evidence of local lesion recurrence or distant metastasis, not suitable for the surgery or radiotherapy for the purpose of cure, and there are no clinical indications of chemotherapy；
* Have a measurable lesion (RECIST (Response Evaluation Criteria In Solid Tumors) 1.1 criteria), or have only bone metastases；
* The main organs function well and meet the following standards：
1. Routine blood examination should meet the following criteria: (No blood transfusion and no hematopoietic stimulation drugs within 7 days before screening)
1. Hemoglobin (HB) ≥100 g/L;
2. Absolute value of neutrophils (NEUT) ≥ 1.5×109/L;
3. Platelet count (PLT) ≥ 90 ×109/L.
2. Biochemical blood tests shall meet the following criteria：
1. Total bilirubin (TBIL) ≤ 1.5 times normal upper limit (ULN);
2. Alanine transferase (ALT) and aspartate transferase (AST) ≤ 2.5×ULN; ALT and AST≤ 3×ULN for patients with liver metastasis;
3. Serum creatinine (Cr) ≤ 1.5×ULN, or creatinine clearance (Ccr) ≥ 60 mL /min；
3. Coagulation function tests shall meet the following criteria：
(a) Prothrombin time (PT), activated partial thrombin time (APTT), international standardized
4. Color doppler echocardiography: Left ventricular ejection fraction (LVEF) ≥50%；
* Female subjects within reproductive age should agree to use contraceptive methods (such as intrauterine devices, birth control pills or condoms) from participating the study to 6 months after the end of the study; Serum pregnancy test result should be negative within 7 days prior to study enrollment and must be non-lactating subjects.
Exclusion Criteria
1. The presence or current co-occurrence of other malignant tumors within 5 years, except ured cervical carcinoma in situ, non-melanoma skin cancer, and superficial bladder tumors \[Ta (non-invasive tumor), Tis (carcinoma in situ), and T1 (tumor infiltrating basal membrane)\];
2. Multiple factors affecting oral and drug absorption (such as inability to swallow, post-gastrointestinal resection, ulcerative colitis, symptomatic/inflammatory bowel disease, chronic diarrhea and intestinal obstruction);
3. Patients with a history of severe pneumonia such as interstitial lung disease;
4. Unrelieved toxicity higher than GRADE 1 Common Terminology Criteria for Adverse Events (CTCAE) due to any previous anti-tumor treatment, hair loss is not included;
5. Major surgery or significant traumatic injury within 28 days prior to randomization;
6. Long-term unhealed wounds, ulcers or fractures;
7. Occurrence of arteriovenous/venous thrombosis events within 6 months, such as cerebrovascular accident (including transient ischemic attack, cerebral hemorrhage, cerebral infarction), deep vein thrombosis and pulmonary embolism, etc.;
8. History of psychotropic drug abuse and can't get rid of it or with mental disorders;
9. Subject with any severe and/or uncontrolled disease, including：
1. Arrhythmias requiring treatment with grade≥2 myocardial ischemia, myocardial infarction, and congestive heart failure (NYHA(New York Heart Association) classification) within 6 months prior to study enrollment (including qtc≥480ms during screening period); And uncontrolled high blood pressure;
2. Active or uncontrolled severe infection (≥CTCAE grade 2 infection) or unexplained fever \> 38.5℃ within 28 days prior to randomization;
3. Decompensated cirrhosis (Child-Pugh liver function score B or C), active hepatitis ;
4. Patients with renal failure requiring hemodialysis or peritoneal dialysis;
5. A history of immunodeficiency, including HIV ( Human Immunodeficiency Virus) positive or other acquired or congenital immunodeficiency diseases, or a history of organ transplantation or hematopoietic stem cell transplantation;
* Tumor-related symptoms and treatment；
1. Visceral crisis exists;
2. Severe bone injury due to bone metastasis of tumor;
3. Received radiotherapy (except palliative radiotherapy for non-target lesions) and other anti-tumor therapies (the washout period was calculated from the end of the last treatment) within 2 weeks prior to randomization;
4. Prior medical treatment with fulvestrant, everolimus or CDK4/6 inhibitor;
5. The presence of clinically uncontrolled pleural, ascites and pericardial effusion requiring repeated drainage or medical intervention (14 days prior to randomization);
* Known allergy to fulvestrant, Luteal Hormone Releasing Hormone (LHRH) agonists (e.g. Goserelin), TQB3616/ placebo or any supplement;
* History of live attenuated vaccine vaccination within 28 days prior to randomization or planned live attenuated vaccine vaccination during the study period;
* Participated in clinical trials of other antitumor drugs within 4 weeks pior to randomization;
* With other serious physical or mental diseases or abnormal laboratory tests that may increase the risk of study participation or interfere with the study results, or unsuitable for the study for other reasons considered by investigators.
18 Years
75 Years
FEMALE
No
Sponsors
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Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
INDUSTRY
Responsible Party
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Locations
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The First Affiliated Hospital of Bengbu Medical College
Bengbu, Anhui, China
The First Affiliated Hospital of Wannan Medical College
Wuhu, Anhui, China
Peking University First Hospital
Beijing, Beijing Municipality, China
Beijing Cancer Hospital
Beijing, Beijing Municipality, China
Chongqing University Cancer Hospital
Chongqing, Chongqing Municipality, China
The Southwest Hospital of AMU
Chongqing, Chongqing Municipality, China
Fujian Provincial Cancer Hospital
Fuzhou, Fujian, China
Gansu Provincial Cancer Hospital
Lanzhou, Gansu, China
Lanzhou University Second Hospital
Lanzhou, Gansu, China
Gansu Wuwei Tumour Hospital
Wuwei, Gansu, China
Sun Yat-sen Memorial Hospital, Sun Yat-sen University
Guangzhou, Guangdong, China
Nanfang Hospital Southern Medical University
Guangzhou, Guangdong, China
The Third Affiliated Hospital of Sun Yat-Sen University
Guangzhou, Guangdong, China
Jieyang People's Hospital
Jieyang, Guangdong, China
Maoming people's hospital
Maoming, Guangdong, China
Yue Bei People's Hospital
Shaoguan, Guangdong, China
ShenZhen People's Hospital
Shenzhen, Guangdong, China
PeKing University ShenZhen Hosipital
Shenzhen, Guangdong, China
Zhongshan City People's Hospital
Zhongshan, Guangdong, China
The Fifth Affiliated Hospital of Sun Yat-Sen University
Zhuhai, Guangdong, China
The Second Affiliated Hospital of Guilin Medical University
Guilin, Guangxi, China
Yulin First People's Hospital
Yulin, Guangxi, China
The Affiliated Hospital of Hebei University
Baoding, Hebei, China
Cangzhou Central Hospital
Cangzhou, Hebei, China
Hebei Cangzhou Hospital of Integrated Traditional Chinese
Cangzhou, Hebei, China
Affiliated Hospital of Chengde Medical University
Chengde, Hebei, China
Hebei Petro China Central Hospital
Langfang, Hebei, China
The Fourth Hospital of Hebei Medical University
Shijiazhuang, Hebei, China
Affiliated Cancer Hospital of Harbin Medical University
Harbin, Heilongjiang, China
The Second Affiliated Hospital of Harbin Medical University
Harbin, Heilongjiang, China
Jiamusi Cancer Hospital
Jiamusi, Heilongjiang, China
Luoyang Central Hospital
Luoyang, Henan, China
Nanyang Central Hospital
Nanyang, Henan, China
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, China
Henan Cancer Hospital
Zhengzhou, Henan, China
Yichang Central People's Hospital
Yichang, Hubei, China
The First People's Hospital of Changde
Changde, Hunan, China
The Second Xiangya Hospital of Central South University
Changsha, Hunan, China
Xiangya Hospital of Central South University
Changsha, Hunan, China
Hunan Cancer Hospital
Changsha, Hunan, China
Changzhou Cancer Hospital
Changzhou, Jiangsu, China
Huai'an First People's Hospital
Huai'an, Jiangsu, China
Nanjing Drum Tower Hospital
Nanjing, Jiangsu, China
Jiangsu province hospital
Nanjing, Jiangsu, China
Affiliated Hospital of Nantong University
Nantong, Jiangsu, China
The Affiliated Hospital of Xuzhou Medical University
Xuzhou, Jiangsu, China
The First Affiliated Hospital of Gannan Medical University
Ganzhou, Jiangxi, China
The Third Hospital of Nanchang
Nanchang, Jiangxi, China
Jilin Cancer Hospital
Changchun, Jilin, China
The First Hospital of Jilin University
Changchun, Jilin, China
Second Hospital of Jilin University
Changchun, Jilin, China
The Second Hosptial of DaLian Medical University
Dalian, Liaoning, China
Affiliated Zhongshan Hospital of Dalian University
Dalian, Liaoning, China
The First Affiliated Hospital of Jinzhou Medical University
Jinzhou, Liaoning, China
The First Affiliated Hospital of China Medical University
Shenyang, Liaoning, China
Liaoning Cancer Hospital & Institute
Shenyang, Liaoning, China
Affiliated Hospital of Chifeng University
Chifeng, Neimenggu, China
Inner Mongolia Autonomous Region Cancer Hospital
Hohhot, Neimenggu, China
The Affilliate Hospital of Inner Mongolia Medical Univercity
Hohhot, Neimenggu, China
General Hospital of Ningxia Medical
Yinchuan, Ningxia, China
Qinghai University affiliated hospital
Xining, Qinghai, China
The First Affiliated Hospital of Xi'an Jiaotong University
Xi'an, Shaanxi, China
First Affiliated University Hospital of PLA Air Force Military Medical
Xi'an, Shaanxi, China
Second Affiliated Hospital of PLA Air Force Military Medical
Xi'an, Shaanxi, China
Xi'an International Medical Center Hospital
Xi'an, Shaanxi, China
Binzhou Medical College Affiliated Hospital
Binzhou, Shandong, China
Shandong Cancer Hospital
Jinan, Shandong, China
Affiliated Hospital of Jining Medical University
Jining, Shandong, China
Linyin Cancer Hospital
Linyi, Shandong, China
Qingdao University Affiliated Hospital
Qingdao, Shandong, China
Weifang Hospital of Traditional Chinese Midicine
Weifang, Shandong, China
Yantai Yantai Mountain hospital
Yantai, Shandong, China
Zibo Central Hospital
Zibo, Shandong, China
Huadong Hospital
Shanghai, Shanghai Municipality, China
Shanghai Oriental Hospital
Shanghai, Shanghai Municipality, China
Shanghai Changhai Hospital
Shanghai, Shanghai Municipality, China
Changzhi People's Hospital
Changzhi, Shanxi, China
Shanxi Cancer Hospital
Taiyuan, Shanxi, China
Chinese People's Liberation Army Western Theater General Hospital
Chengdu, Sichuan, China
The Affiliated Hospital of Southwest Medical University
Luzhou, Sichuan, China
Suining Central Hospital
Suining, Sichuan, China
Tianjin Medical University Cancer Hospital
Tianjin, Tianjin Municipality, China
Tianjin Medical University Cancer Hospital Konggang Hospital
Tianjin, Tianjin Municipality, China
Cancer Hospital affiliated to Xinjiang Medical University
Ürümqi, Xinjiang, China
Yunnan Cancel Hospital
Kunming, Yunan, China
Affiliated Hangzhou First People's Hospital, Zhejiang University School of Medcine
Hangzhou, Zhejiang, China
The Second Affiliated Hospital Zhejiang University School of Medicine
Hangzhou, Zhejiang, China
Zhejiang Cancer Hospital
Hangzhou, Zhejiang, China
Countries
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References
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Xu Z, Liu Y, Song B, Ren B, Xu X, Lin R, Zhu X, Chen C, Yang S, Zhu Y, Jiang W, Li W, Xia Y, Hu L, Chen S, Chan CC, Li J, Zhang X, Yang L, Tian X, Ding CZ. Discovery and preclinical evaluations of TQB3616, a novel CDK4-biased inhibitor. Bioorg Med Chem Lett. 2024 Jul 15;107:129769. doi: 10.1016/j.bmcl.2024.129769. Epub 2024 Apr 24.
Other Identifiers
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TQB3616-Ⅲ-02
Identifier Type: -
Identifier Source: org_study_id
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