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NCT05365178

PHASE3

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

Sponsor: Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

View on ClinicalTrials.gov

Summary

A randomized, double-blind, parallel-controlled, multicenter trial design was used in this study. Subjects who meet the criteria will be randomly divided into 2:1 groups to receive TBQ3616 capsule combined with Fulvestrant injection (experimental group) or placebo capsule combined with fulvestrant (control group). A total of 428 subjects were required.

Official title: A Randomized, Double-blind, Parallel-controlled Phase III Trial Evaluating the Efficacy and Safety of TQB3616 in Combination With Fulvestrant Versus Placebo in Combination With Fulvestrant in Previously Untreated HR-positive, HER2-negative Advanced Breast Cancer

Key Details

Gender

FEMALE

Age Range

18 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

432

Start Date

2022-07-01

Completion Date

2026-06

Last Updated

2026-01-07

Healthy Volunteers

Conditions

HR-positive, HER2-negative Breast Neoplasms

Interventions

DRUG

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

DRUG

Placebo

It is a placebo

DRUG

Fulvestrant injection

Fulvestrant is a competitive estrogen receptor antagonist, and its mechanism is related to the down-regulation of estrogen receptor (ER) protein level

Inclusion Criteria: * Subjects voluntarily participate in this study and sign informed consent with good compliance; * 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: * Associated diseases and history： 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.

Locations (88)

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

Clinical Research Directory

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

Summary

Key Details

Conditions

Interventions

Eligibility Criteria

Locations (88)