CompletedNCT05375461Updated Apr 8, 2026

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

A Phase 3 interventional study of TQB3616 capsules and TQB3616-matching placebo in HR-positive,HER2-negative in Advanced Breast Cancer, sponsored by Chia Tai Tianqing Pharmaceutical Group Co., Ltd.. Completed at 2 sites in China. Open to female participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-04-08.

Sponsored by Chia Tai Tianqing Pharmaceutical Group Co., Ltd. · Phase 3, Interventional, and Treatment

Phase: Phase 3
Study type: Interventional
Enrollment: 293
Allocation: Randomized
Ages: 18 Years to 75 Years
Sex: Female

Study summary

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 studied

HR-positive,HER2-negative in Advanced Breast Cancer

In context

Lead sponsor

Chia Tai Tianqing Pharmaceutical Group Co., Ltd. is the lead sponsor of 313 studies on the registry; 75 are open to participants now.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years to 75 Years
Sexes eligible: Female
Accepts healthy volunteers: No

Inclusion criteria

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%.

Exclusion criteria

Exclusion Criteria:

1 Complicated diseases and medical history:
1. Has had other malignant tumors within 3 years or currently has other malignant tumors;
2. Have a variety of factors that affect oral medication (such as inability to swallow, chronic diarrhea, and intestinal obstruction);
3. Unmitigated toxicity above CTCAE1 grade due to any prior treatment;
4. Severe infections (≥CTCAE2 grade) that were active or uncontrolled before the study treatment started;
5. Cirrhosis, active hepatitis；
6. 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:
1. Clinical evidence or history of central nervous system metastases (CNS) and/or cancerous meningitis or pneumomeningeal disease;
2. 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);
3. 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.

Study design

Phase: Phase 3
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel assignment
Masking: Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment: 293 participants (actual)

Study arms

Experimental
TQB3616 capsules plus fulvestrant
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.
Drug: TQB3616 capsules · Drug: Fluvestrin injection
Placebo comparator
TQB3616-matching placebo plus fulvestrant
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.
Drug: TQB3616-matching placebo · Drug: Fluvestrin injection

Interventions

DrugTQB3616 capsules
The dose of TQB3616 capsules is 180mg, taken orally on an empty stomach, once a day for 28 consecutive days as one treatment cycle.
DrugTQB3616-matching placebo
The dose of placebo is 180mg, taken orally on an empty stomach, once a day for 28 consecutive days as one treatment cycle.
DrugFluvestrin injection
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.

What researchers measure

Primary outcomes

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

Secondary outcomes

Progression-free survival (PFS) by Independent Review Committee
Progression-free survival（First-time progression of disease/ recurrence /death）
Time frame: Baseline up to 24 months
Overall survival (OS)
Overall survival (Baseline up to death)
Time frame: 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）
Time frame: Baseline up to 24 months
Duration of Response (DOR)
Duration of Response(Baseline up to progression of disease/ recurrence /death)
Time frame: Baseline up to 24 months

Study locations

2 sites

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

References and documents

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 ↗

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Apr 8, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT05375461
Lead sponsor: Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
Responsible party: Sponsor
First posted: May 16, 2022
Start date: Mar 18, 2022
Primary completion: Jan 16, 2024
Completion: Dec 9, 2025
Last update: Apr 8, 2026

Oversight

FDA-regulated drug: No
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Apr 2026. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies from this sponsor

Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

Start the discussion