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HR-positive, HER2-negative Breast NeoplasmsPhase 3NCT05365178

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

A Phase 3 study testing TQB3616 capsule and Fulvestrant injection in people with HR-positive, HER2-negative Breast Neoplasms, run by Chia Tai Tianqing Pharmaceutical Group Co., Ltd. at 88 sites in China.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
Search all trials

Trial 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). Read more about this study

Who is it for?
Ages 18 to 75 years, women only
What is being tested?
TQB3616 capsule and Fulvestrant injection
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
432 participants
Where
88 sitesChina
Study dates
1 Jul 2022to Jun 2026
Phase
Phase 3
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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：
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  • Routine blood examination should meet the following criteria: (No blood transfusion and no hematopoietic stimulation drugs within 7 days before screening)
  • Hemoglobin (HB) ≥100 g/L;
  • Absolute value of neutrophils (NEUT) ≥ 1.5×109/L;
  • Platelet count (PLT) ≥ 90 ×109/L.
  • Biochemical blood tests shall meet the following criteria：
  • Total bilirubin (TBIL) ≤ 1.5 times normal upper limit (ULN);
  • Alanine transferase (ALT) and aspartate transferase (AST) ≤ 2.5×ULN; ALT and AST≤ 3×ULN for patients with liver metastasis;
  • Serum creatinine (Cr) ≤ 1.5×ULN, or creatinine clearance (Ccr) ≥ 60 mL /min；
  • Coagulation function tests shall meet the following criteria：
  • Prothrombin time (PT), activated partial thrombin time (APTT), international standardized
  • 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.

Who cannot join

  • Associated diseases and history：
  • 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)];
  • 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);
  • Patients with a history of severe pneumonia such as interstitial lung disease;
  • 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;
  • Major surgery or significant traumatic injury within 28 days prior to randomization;
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  • Long-term unhealed wounds, ulcers or fractures;
  • 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.;
  • History of psychotropic drug abuse and can't get rid of it or with mental disorders;
  • Subject with any severe and/or uncontrolled disease, including：
  • 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;
  • Active or uncontrolled severe infection (≥CTCAE grade 2 infection) or unexplained fever > 38.5℃ within 28 days prior to randomization;
  • Decompensated cirrhosis (Child-Pugh liver function score B or C), active hepatitis ;
  • Patients with renal failure requiring hemodialysis or peritoneal dialysis;
  • 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；
  • Visceral crisis exists;
  • Severe bone injury due to bone metastasis of tumor;
  • 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;
  • Prior medical treatment with fulvestrant, everolimus or CDK4/6 inhibitor;
  • 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.

Trial locations and contacts

88 sites in 1 country.

88 sites in 1 country

China88 sites

  • The Affiliated Hospital of Hebei University

    Baoding, Hebei, 071000

  • Peking University First Hospital

    Beijing, Beijing Municipality, 100034

  • Beijing Cancer Hospital

    Beijing, Beijing Municipality, 100142

  • The First Affiliated Hospital of Bengbu Medical College

    Bengbu, Anhui, 233099

  • Binzhou Medical College Affiliated Hospital

    Binzhou, Shandong, 256699

  • Cangzhou Central Hospital

    Cangzhou, Hebei, 061013

  • Hebei Cangzhou Hospital of Integrated Traditional Chinese

    Cangzhou, Hebei, 061013

  • Jilin Cancer Hospital

    Changchun, Jilin, 130012

  • The First Hospital of Jilin University

    Changchun, Jilin, 130021

  • Second Hospital of Jilin University

    Changchun, Jilin, 130041

  • The First People's Hospital of Changde

    Changde, Hunan, 415003

  • The Second Xiangya Hospital of Central South University

    Changsha, Hunan, 410000

  • Xiangya Hospital of Central South University

    Changsha, Hunan, 410000

  • Hunan Cancer Hospital

    Changsha, Hunan, 410031

  • Changzhi People's Hospital

    Changzhi, Shanxi, 046000

  • Changzhou Cancer Hospital

    Changzhou, Jiangsu, 213000

  • Affiliated Hospital of Chengde Medical University

    Chengde, Hebei, 067020

  • Chinese People's Liberation Army Western Theater General Hospital

    Chengdu, Sichuan, 610083

  • Affiliated Hospital of Chifeng University

    Chifeng, Neimenggu, 024005

  • Chongqing University Cancer Hospital

    Chongqing, Chongqing Municipality, 400000

  • The Southwest Hospital of AMU

    Chongqing, Chongqing Municipality, 400083

  • The Second Hosptial of DaLian Medical University

    Dalian, Liaoning, 116000

  • Affiliated Zhongshan Hospital of Dalian University

    Dalian, Liaoning, 116001

  • Fujian Provincial Cancer Hospital

    Fuzhou, Fujian, 350014

  • The First Affiliated Hospital of Gannan Medical University

    Ganzhou, Jiangxi, 341099

  • Sun Yat-sen Memorial Hospital, Sun Yat-sen University

    Guangzhou, Guangdong, 510060

  • Nanfang Hospital Southern Medical University

    Guangzhou, Guangdong, 510080

  • The Third Affiliated Hospital of Sun Yat-Sen University

    Guangzhou, Guangdong, 510630

  • The Second Affiliated Hospital of Guilin Medical University

    Guilin, Guangxi, 541199

  • Affiliated Hangzhou First People's Hospital, Zhejiang University School of Medcine

    Hangzhou, Zhejiang, 310006

  • The Second Affiliated Hospital Zhejiang University School of Medicine

    Hangzhou, Zhejiang, 310009

  • Zhejiang Cancer Hospital

    Hangzhou, Zhejiang, 310022

  • Affiliated Cancer Hospital of Harbin Medical University

    Harbin, Heilongjiang, 150081

  • The Second Affiliated Hospital of Harbin Medical University

    Harbin, Heilongjiang, 150086

  • Inner Mongolia Autonomous Region Cancer Hospital

    Hohhot, Neimenggu, 010000

  • The Affilliate Hospital of Inner Mongolia Medical Univercity

    Hohhot, Neimenggu, 010000

  • Huai'an First People's Hospital

    Huai'an, Jiangsu, 223300

  • Jiamusi Cancer Hospital

    Jiamusi, Heilongjiang, 154007

  • Jieyang People's Hospital

    Jieyang, Guangdong, 522095

  • Shandong Cancer Hospital

    Jinan, Shandong, 250117

  • Affiliated Hospital of Jining Medical University

    Jining, Shandong, 272000

  • The First Affiliated Hospital of Jinzhou Medical University

    Jinzhou, Liaoning, 121012

  • Yunnan Cancel Hospital

    Kunming, Yunan, 650106

  • Hebei Petro China Central Hospital

    Langfang, Hebei, 065000

  • Gansu Provincial Cancer Hospital

    Lanzhou, Gansu, 730000

  • Lanzhou University Second Hospital

    Lanzhou, Gansu, 730030

  • Linyin Cancer Hospital

    Linyi, Shandong, 276000

  • Luoyang Central Hospital

    Luoyang, Henan, 471003

  • The Affiliated Hospital of Southwest Medical University

    Luzhou, Sichuan, 646000

  • Maoming people's hospital

    Maoming, Guangdong, 525000

  • The Third Hospital of Nanchang

    Nanchang, Jiangxi, 330000

  • Nanjing Drum Tower Hospital

    Nanjing, Jiangsu, 210008

  • Jiangsu province hospital

    Nanjing, Jiangsu, 210029

  • Affiliated Hospital of Nantong University

    Nantong, Jiangsu, 226001

  • Nanyang Central Hospital

    Nanyang, Henan, 473000

  • Qingdao University Affiliated Hospital

    Qingdao, Shandong, 266071

  • Huadong Hospital

    Shanghai, Shanghai Municipality, 200040

  • Shanghai Oriental Hospital

    Shanghai, Shanghai Municipality, 200123

  • Shanghai Changhai Hospital

    Shanghai, Shanghai Municipality, 200433

  • Yue Bei People's Hospital

    Shaoguan, Guangdong, 512025

  • The First Affiliated Hospital of China Medical University

    Shenyang, Liaoning, 110002

  • Liaoning Cancer Hospital & Institute

    Shenyang, Liaoning, 110042

  • ShenZhen People's Hospital

    Shenzhen, Guangdong, 518020

  • PeKing University ShenZhen Hosipital

    Shenzhen, Guangdong, 518036

  • The Fourth Hospital of Hebei Medical University

    Shijiazhuang, Hebei, 050011

  • Suining Central Hospital

    Suining, Sichuan, 629000

  • Shanxi Cancer Hospital

    Taiyuan, Shanxi, 030013

  • Tianjin Medical University Cancer Hospital

    Tianjin, Tianjin Municipality, 300060

  • Tianjin Medical University Cancer Hospital Konggang Hospital

    Tianjin, Tianjin Municipality, 300308

  • Cancer Hospital affiliated to Xinjiang Medical University

    Ürümqi, Xinjiang, 830011

  • Weifang Hospital of Traditional Chinese Midicine

    Weifang, Shandong, 261000

  • The First Affiliated Hospital of Wannan Medical College

    Wuhu, Anhui, 241000

  • Gansu Wuwei Tumour Hospital

    Wuwei, Gansu, 730000

  • The First Affiliated Hospital of Xi'an Jiaotong University

    Xi'an, Shaanxi, 710000

  • First Affiliated University Hospital of PLA Air Force Military Medical

    Xi'an, Shaanxi, 710032

  • Second Affiliated Hospital of PLA Air Force Military Medical

    Xi'an, Shaanxi, 710038

  • Xi'an International Medical Center Hospital

    Xi'an, Shaanxi, 710100

  • Qinghai University affiliated hospital

    Xining, Qinghai, 810000

  • The Affiliated Hospital of Xuzhou Medical University

    Xuzhou, Jiangsu, 221004

  • Yantai Yantai Mountain hospital

    Yantai, Shandong, 264008

  • Yichang Central People's Hospital

    Yichang, Hubei, 443003

  • General Hospital of Ningxia Medical

    Yinchuan, Ningxia, 750003

  • Yulin First People's Hospital

    Yulin, Guangxi, 537000

  • The First Affiliated Hospital of Zhengzhou University

    Zhengzhou, Henan, 450052

  • Henan Cancer Hospital

    Zhengzhou, Henan, 45008

  • Zhongshan City People's Hospital

    Zhongshan, Guangdong, 528403

  • The Fifth Affiliated Hospital of Sun Yat-Sen University

    Zhuhai, Guangdong, 519099

  • Zibo Central Hospital

    Zibo, Shandong, 255020

Other trials in China

About this study

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

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.

Being tested
TQB3616 capsule, Placebo, Fulvestrant injection

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • TQB3616 capsuleDrug

    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

  • PlaceboDrug

    It is a placebo

  • Fulvestrant injectionDrug

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

Study groups in NCT05365178
Study groupRoleWhat they receive
TQB3616 capsule + Fulvestrant injectionExperimentalTQB3616 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
Receives: Drug: TQB3616 capsule; Drug: Fulvestrant injection
Placebo capsule + Fulvestrant injectionPlacebo comparatorPlacebo 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
Receives: Drug: Placebo; Drug: Fulvestrant injection

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Progression-free survival as assessed by the investigator

    The time from enrollment to the date of the first documentation of objective progression of disease or death due to any cause, whichever occurs first.

    Measured: Baseline up to progressive disease (PD)/die, about 25.8 months

Secondary outcomes (8)

  1. Progression-free survival (PFS) by independent imaging assessment

    The time from enrollment to the date of the first documentation of objective progression of disease or death due to any cause, whichever occurs first.

    Measured: Baseline up to PD/die, about 25.8 months

  2. Overall survival

    Overall survival was defined as the time from randomization to death from any cause.

    Measured: Baseline up to die, about 36months

  3. 3-Year Overall Survival (OS)

    The percentage of participants of survival above 3 years

    Measured: Baseline to 3 years

  4. Objective Response Rate (ORR)

    Measured: Baseline to CR/PR，about 1 year

  5. Clinical Benefit Rate(CBR)

    Calculated as the percentage of participants with best overall response of CR, PR, stable disease (SD) and Non-CR/Non-progressive disease (PD).

    Measured: Baseline to CR/PR/SD，about 1 year

  6. Duration of Overall Response (DOR)

    The time from the date of participants with a first overall response defined as complete response (CR) or partial response (PR) to the date of the first documentation of objective progression of disease or death due to any cause, whichever occurs first.

    Measured: CR/PR assessment, up to PD/die, about 20 months

  7. The European Organization for Research and Treatment of Cancer Quality of Life questionnaire

    Sense of satisfaction, life quality of participants since the enrollment of the study

    Measured: Baseline to the end of the study, about 3 years

  8. Incidence of adverse events (AEs), serious adverse events (SAEs) and treatment-related adverse events (TEAEs).

    The occurrence of all adverse events (AEs), serious adverse events (SAEs) and treatment-related adverse events (TEAEs).

    Measured: Baseline to the end of the study, about 3 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 May 2022
  2. Study start1 Jul 2022
  3. Primary completion2 Jul 2025
  4. Study completionJun 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
432 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05365178
Sponsor's protocol ID
TQB3616-Ⅲ-02
Status last verified
Jul 2025
First submitted
26 Apr 2022
Last updated
7 Jan 2026
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • 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.

    PubMed 38670537

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing TQB3616 capsule and Fulvestrant injection in people with HR-positive, HER2-negative Breast Neoplasms, run by Chia Tai Tianqing Pharmaceutical Group Co., Ltd. at 88 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 18 inclusion and 25 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 7 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 88 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Progression-free survival as assessed by the investigator (time frame: Baseline up to progressive disease (PD)/die, about 25.8 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05365178, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jan 2026.

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