HR-positive,HER2-negative in Advanced Breast CancerPhase 3NCT05375461

TQB3616 Capsules Plus Fulvestrant Compared to Placebo Plus Fulvestrant in Previously Treated Breast Cancer in Clinical Trail

A Phase 3 study testing TQB3616 capsules and Fluvestrin injection in people with HR-positive,HER2-negative in Advanced Breast Cancer, run by Chia Tai Tianqing Pharmaceutical Group Co., Ltd. at 2 sites in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 to 75 years, women only
Conditions the study is for: HR-positive,HER2-negative in Advanced Breast Cancer
What is being tested?: TQB3616 capsules and Fluvestrin injection
Type of treatment: Pill or oral medicine, Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 293 participants
Where: 2 sitesChina
Study dates: 18 Mar 2022to 9 Dec 2025
Phase: Phase 3

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

1 The subjects voluntarily joined the study and signed the informed consent, with good compliance.
2 Age: 18-75 years old (upon signing the informed consent);ECOG PS score: 0~1; Expected survival ≥3 months.
3 participants with estrogen receptor-positive, HER2-Negative Advanced Breast Cancer were identified by pathological testing.
4 Patients at the relapse/metastatic stage were allowed to receive no more than 1 line of rescue chemotherapy or rescue endocrine therapy.
5 Confirmation of at least one measurable lesion according to RECIST1.1 criteria.
6 The main organs are functioning well and meet the following criteria: Routine blood examination criteria (no blood transfusion or hematopoietic stimulus drug correction within 7 days before screening) : a) hemoglobin (Hb) ≥100g/L; b) neutrophils absolute value (NEUT) ≥1.5×10^9/L; c) Platelet count (PLT) ≥90×10^9/L.
Biochemical tests should meet the following criteria: a) Total bilirubin (TBIL) ≤2.5 times the upper limit of normal (ULN); b) Alanine transferase (ALT) and aspartate transferase (AST) ≤2.5×ULN.ALT and AST≤5×ULN with liver metastasis. c) Serum creatinine (Cr) ≤1.5×ULN, or creatinine clearance rate (CCR) ≥60ml/min.
The blood coagulation function test should meet the following criteria: prothrombin time (PT), activated partial thromboplastin time (APTT), international standardized ratio (INR) ≤1.5×ULN (no anticoagulant therapy); Cardiac ultrasound evaluation: left ventricular ejection fraction (LVEF)≥50%.

Who cannot join

1 Complicated diseases and medical history:
Has had other malignant tumors within 3 years or currently has other malignant tumors;
Have a variety of factors that affect oral medication (such as inability to swallow, chronic diarrhea, and intestinal obstruction);
Unmitigated toxicity above CTCAE1 grade due to any prior treatment;
Severe infections (≥CTCAE2 grade) that were active or uncontrolled before the study treatment started;
Cirrhosis, active hepatitis；

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Have a history of immunodeficiency, including HIV positive or other acquired or congenital immunodeficiency diseases, or have a history of organ transplantation;
2 Tumor-related symptoms and treatment:
Clinical evidence or history of central nervous system metastases (CNS) and/or cancerous meningitis or pneumomeningeal disease;
Had received chemotherapy within 3 weeks prior to the start of study treatment, and had received radiotherapy (except palliative radiotherapy for non-target lesions), hormone therapy, or other anti-tumor therapy within 2 weeks prior to the start of study treatment (washout period was calculated from the end of last treatment);
Uncontrolled pleural effusion, pericardial effusion, or ascites that still require repeated drainage (as determined by the investigator).
3 Known to be allergic to fluvestone, TQB3616 or any excipient.
4 Participated in clinical trials of other antitumor drugs within 4 weeks prior to the initiation of study therapy.
5 Has other conditions that make it inappropriate for the patient to be enrolled based on investigator's opinion.

Trial locations and contacts

2 sites in 1 country.

China2 sites

The Fifth Medical Center of PLA General Hospital
Beijing, Beijing Municipality, 100039
Beijing Cancer Hosptital
Beijing, Beijing Municipality, 100142

Other trials in China

About this study

Official title: A Phase III,Randomized, Double-blind, Paralle, Multi-center Study to Evaluate the Efficacy and Safety of TQB3616 Capsules Plus Fulvestrant Compared to Placebo Plus Fulvestrant in Participants With Hormone Receptor (HR)-Positive, Human Epidermal Growth Factor Receptor(EGFR) 2-Negative Advanced Breast Cancer

This is a Phase III, a randomized, double-blind, parallel , multi-center trail to evaluate the efficacy and safety of TQB3616 capsules plus fulvestrant compared to placebo plus fulvestrant in participants with estrogen receptor-positive, HER2-Negative Advanced Breast Cancer. Approximately 287 women will be randomized to either TQB3616 plus fulvestrant or TQB3616-matching placebo plus fulvestrant. Randomization will follow a 2:1 randomization ratio,the experimental is 191; the Placebo Comparator is 96.

Conditions: HR-positive,HER2-negative in Advanced Breast Cancer
Being tested: TQB3616 capsules, TQB3616-matching placebo, Fluvestrin injection

What participants receive

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

TQB3616 capsulesDrug
The dose of TQB3616 capsules is 180mg, taken orally on an empty stomach, once a day for 28 consecutive days as one treatment cycle.
TQB3616-matching placeboDrug
The dose of placebo is 180mg, taken orally on an empty stomach, once a day for 28 consecutive days as one treatment cycle.
Fluvestrin injectionDrug
Fluvestrin injection was given at a fixed dose of 500mg on day 1, day 15 of the first treatment cycle and day 1 of each subsequent treatment cycle, and a treatment cycle of 28 days.

Study groups in NCT05375461
Study group	Role	What they receive
TQB3616 capsules plus fulvestrant	Experimental	The dose of TQB3616 capsules is 180mg, taken orally on an empty stomach, once a day for 28 consecutive days as one treatment cycle. Fluvestrin injection was given at a fixed dose of 500mg on day 1, day 15 of the first treatment cycle and day 1 of each subsequent treatment cycle, and a treatment cycle of 28 days. Receives: Drug: TQB3616 capsules; Drug: Fluvestrin injection
TQB3616-matching placebo plus fulvestrant	Placebo comparator	The dose of placebo is 180mg, taken orally on an empty stomach, once a day for 28 consecutive days as one treatment cycle. Fluvestrin injection was given at a fixed dose of 500mg on day 1, day 15 of the first treatment cycle and day 1 of each subsequent treatment cycle, and a treatment cycle of 28 days. Receives: Drug: TQB3616-matching placebo; Drug: Fluvestrin injection

What is being measured

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

Progression-free survival (PFS)
Progression-free survival (First-time progression of disease/ recurrence /death)
Measured: Baseline up to 24 months

Secondary outcomes (4)

Progression-free survival (PFS) by Independent Review Committee
Progression-free survival（First-time progression of disease/ recurrence /death）
Measured: Baseline up to 24 months
Overall survival (OS)
Overall survival (Baseline up to death)
Measured: Baseline up to 24 months
Clinical benefit rate (CBR)
Percentage of subjects with complete (CR) or partial response (PR) or stable disease (SD)（ Baseline up to progression of disease/ recurrence /death）
Measured: Baseline up to 24 months
Duration of Response (DOR)
Duration of Response(Baseline up to progression of disease/ recurrence /death)
Measured: Baseline up to 24 months

Timeline

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

18 Mar 20229 Dec 2025

First posted16 May 2022
Study start18 Mar 2022
Primary completion16 Jan 2024
Study completion9 Dec 2025

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (2)Papers the sponsor has linked to this study.
Other trials for HR-positive,HER2-negative in Advanced Breast CancerStudies of the same condition, open and under way.
More trials run by Chia Tai Tianqing Pharmaceutical Group Co., Ltd.The sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

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: 293 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05375461
Sponsor's protocol ID: TQB3616-III-01
Status last verified: Apr 2026
First submitted: 11 May 2022
Last updated: 8 Apr 2026
Results posted: No
FDA-regulated drug: No
FDA-regulated device: No

Publications

Yin Y, Zhang Q, Sun T, Hao C, Wang Z, Yang J, Wang Y, Shi Y, Sun J, Ouyang Q, Su H, Wu J, Gan L, Han M, Gao L, Wang X, Zhao B, Li H, Zhao J, Yang H, Ning F, Tian F, Zhang J, Sun H, Niu Z, Zong H, Zang A, Wang X, Qian X, Wu S, Nie J, He L, Cheng Y, Hao Y, Zhai Y, Li H, Wang J, Wei S, Li M, Liu Y, Guo H, Hu Q, Liu L, Han X, Luo R, Ni M, Tang X, Zhai Z, Ding M, Wang H, Shen P, Wang X, Liu L, Chen W, Liu G, Cai Z, Jiang Z. Novel CDK2/4/6 inhibitor culmerciclib (TQB3616) plus fulvestrant in previously treated, HR-positive, HER2-negative advanced breast cancer: a randomized, double-blind, phase 3 trial. Signal Transduct Target Ther. 2025 Dec 18;10(1):414. doi: 10.1038/s41392-025-02475-6.
PubMed 41413016
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

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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