New pill combo aims to slow advanced breast cancer

NCT ID NCT05365178

Disease control Sponsor: Chia Tai Tianqing Pharmaceutical Group Co., Ltd. Source: ClinicalTrials.gov ↗

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This phase 3 trial tests whether adding an experimental drug (TQB3616) to standard hormone therapy (fulvestrant) can delay cancer growth in people with HR-positive, HER2-negative advanced breast cancer. About 432 participants will receive either the combination or a placebo plus fulvestrant. The main goal is to see how long the cancer stays under control.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance: TQB3616 (a CDK 2/4/6 inhibitor) combined with fulvestrant
What this could lead to: If successful, this combination could offer a new treatment option to delay cancer growth in people with HR-positive, HER2-negative advanced breast cancer.
What could go wrong: This is a phase 3 trial, but results are not yet available. The drug may not improve outcomes significantly, and side effects from the combination are possible.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

432 people

The number who actually took part.

Started

Jul 2022

Expected to finish

Jun 2026

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 75 years

Sex

Female participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

hormone receptor-positive breast cancer

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

HR-positive, HER2-negative breast neoplasms

Contacts and locations

Locations

Affiliated Cancer Hospital of Harbin Medical University

Harbin, Heilongjiang, 150081, China
Affiliated Hangzhou First People's Hospital, Zhejiang University School of Medcine

Hangzhou, Zhejiang, 310006, China
Affiliated Hospital of Chengde Medical University

Chengde, Hebei, 067020, China
Affiliated Hospital of Chifeng University

Chifeng, Neimenggu, 024005, China
Affiliated Hospital of Jining Medical University

Jining, Shandong, 272000, China
Affiliated Hospital of Nantong University

Nantong, Jiangsu, 226001, China
Affiliated Zhongshan Hospital of Dalian University

Dalian, Liaoning, 116001, China
Beijing Cancer Hospital

Beijing, Beijing Municipality, 100142, China
Binzhou Medical College Affiliated Hospital

Binzhou, Shandong, 256699, China
Cancer Hospital affiliated to Xinjiang Medical University

Ürümqi, Xinjiang, 830011, China
Cangzhou Central Hospital

Cangzhou, Hebei, 061013, China
Changzhi People's Hospital

Changzhi, Shanxi, 046000, China
Changzhou Cancer Hospital

Changzhou, Jiangsu, 213000, China
Chinese People's Liberation Army Western Theater General Hospital

Chengdu, Sichuan, 610083, China
Chongqing University Cancer Hospital

Chongqing, Chongqing Municipality, 400000, China
First Affiliated University Hospital of PLA Air Force Military Medical

Xi'an, Shaanxi, 710032, China
Fujian Provincial Cancer Hospital

Fuzhou, Fujian, 350014, China
Gansu Provincial Cancer Hospital

Lanzhou, Gansu, 730000, China
Gansu Wuwei Tumour Hospital

Wuwei, Gansu, 730000, China
General Hospital of Ningxia Medical

Yinchuan, Ningxia, 750003, China
Hebei Cangzhou Hospital of Integrated Traditional Chinese

Cangzhou, Hebei, 061013, China
Hebei Petro China Central Hospital

Langfang, Hebei, 065000, China
Henan Cancer Hospital

Zhengzhou, Henan, 45008, China
Huadong Hospital

Shanghai, Shanghai Municipality, 200040, China
Huai'an First People's Hospital

Huai'an, Jiangsu, 223300, China
Hunan Cancer Hospital

Changsha, Hunan, 410031, China
Inner Mongolia Autonomous Region Cancer Hospital

Hohhot, Neimenggu, 010000, China
Jiamusi Cancer Hospital

Jiamusi, Heilongjiang, 154007, China
Jiangsu province hospital

Nanjing, Jiangsu, 210029, China
Jieyang People's Hospital

Jieyang, Guangdong, 522095, China
Jilin Cancer Hospital

Changchun, Jilin, 130012, China
Lanzhou University Second Hospital

Lanzhou, Gansu, 730030, China
Liaoning Cancer Hospital & Institute

Shenyang, Liaoning, 110042, China
Linyin Cancer Hospital

Linyi, Shandong, 276000, China
Luoyang Central Hospital

Luoyang, Henan, 471003, China
Maoming people's hospital

Maoming, Guangdong, 525000, China
Nanfang Hospital Southern Medical University

Guangzhou, Guangdong, 510080, China
Nanjing Drum Tower Hospital

Nanjing, Jiangsu, 210008, China
Nanyang Central Hospital

Nanyang, Henan, 473000, China
PeKing University ShenZhen Hosipital

Shenzhen, Guangdong, 518036, China
Peking University First Hospital

Beijing, Beijing Municipality, 100034, China
Qingdao University Affiliated Hospital

Qingdao, Shandong, 266071, China
Qinghai University affiliated hospital

Xining, Qinghai, 810000, China
Second Affiliated Hospital of PLA Air Force Military Medical

Xi'an, Shaanxi, 710038, China
Second Hospital of Jilin University

Changchun, Jilin, 130041, China
Shandong Cancer Hospital

Jinan, Shandong, 250117, China
Shanghai Changhai Hospital

Shanghai, Shanghai Municipality, 200433, China
Shanghai Oriental Hospital

Shanghai, Shanghai Municipality, 200123, China
Shanxi Cancer Hospital

Taiyuan, Shanxi, 030013, China
ShenZhen People's Hospital

Shenzhen, Guangdong, 518020, China
Suining Central Hospital

Suining, Sichuan, 629000, China
Sun Yat-sen Memorial Hospital, Sun Yat-sen University

Guangzhou, Guangdong, 510060, China
The Affiliated Hospital of Hebei University

Baoding, Hebei, 071000, China
The Affiliated Hospital of Southwest Medical University

Luzhou, Sichuan, 646000, China
The Affiliated Hospital of Xuzhou Medical University

Xuzhou, Jiangsu, 221004, China
The Affilliate Hospital of Inner Mongolia Medical Univercity

Hohhot, Neimenggu, 010000, China
The Fifth Affiliated Hospital of Sun Yat-Sen University

Zhuhai, Guangdong, 519099, China
The First Affiliated Hospital of Bengbu Medical College

Bengbu, Anhui, 233099, China
The First Affiliated Hospital of China Medical University

Shenyang, Liaoning, 110002, China
The First Affiliated Hospital of Gannan Medical University

Ganzhou, Jiangxi, 341099, China
The First Affiliated Hospital of Jinzhou Medical University

Jinzhou, Liaoning, 121012, China
The First Affiliated Hospital of Wannan Medical College

Wuhu, Anhui, 241000, China
The First Affiliated Hospital of Xi'an Jiaotong University

Xi'an, Shaanxi, 710000, China
The First Affiliated Hospital of Zhengzhou University

Zhengzhou, Henan, 450052, China
The First Hospital of Jilin University

Changchun, Jilin, 130021, China
The First People's Hospital of Changde

Changde, Hunan, 415003, China
The Fourth Hospital of Hebei Medical University

Shijiazhuang, Hebei, 050011, China
The Second Affiliated Hospital Zhejiang University School of Medicine

Hangzhou, Zhejiang, 310009, China
The Second Affiliated Hospital of Guilin Medical University

Guilin, Guangxi, 541199, China
The Second Affiliated Hospital of Harbin Medical University

Harbin, Heilongjiang, 150086, China
The Second Hosptial of DaLian Medical University

Dalian, Liaoning, 116000, China
The Second Xiangya Hospital of Central South University

Changsha, Hunan, 410000, China
The Southwest Hospital of AMU

Chongqing, Chongqing Municipality, 400083, China
The Third Affiliated Hospital of Sun Yat-Sen University

Guangzhou, Guangdong, 510630, China
The Third Hospital of Nanchang

Nanchang, Jiangxi, 330000, China
Tianjin Medical University Cancer Hospital

Tianjin, Tianjin Municipality, 300060, China
Tianjin Medical University Cancer Hospital Konggang Hospital

Tianjin, Tianjin Municipality, 300308, China
Weifang Hospital of Traditional Chinese Midicine

Weifang, Shandong, 261000, China
Xi'an International Medical Center Hospital

Xi'an, Shaanxi, 710100, China
Xiangya Hospital of Central South University

Changsha, Hunan, 410000, China
Yantai Yantai Mountain hospital

Yantai, Shandong, 264008, China
Yichang Central People's Hospital

Yichang, Hubei, 443003, China
Yue Bei People's Hospital

Shaoguan, Guangdong, 512025, China
Yulin First People's Hospital

Yulin, Guangxi, 537000, China
Yunnan Cancel Hospital

Kunming, Yunan, 650106, China
Zhejiang Cancer Hospital

Hangzhou, Zhejiang, 310022, China
Zhongshan City People's Hospital

Zhongshan, Guangdong, 528403, China
Zibo Central Hospital

Zibo, Shandong, 255020, China