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

NCT05375461 | Completed Phase 3

• 1 other identifier: TQB3616-III-01
• Study Type: interventional
• Target: 293
• Locations: 1 country
• Sites: 2

Brief 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

HR-positive,HER2-negative in Advanced Breast Cancer

Outcome Measures

Primary Outcomes (1)

• Progression-free survival (PFS)

  Progression-free survival (First-time progression of disease/ recurrence /death)

  Baseline up to 24 months

Secondary Outcomes (4)

• Progression-free survival (PFS) by Independent Review Committee

  Baseline up to 24 months

• Overall survival (OS)

  Baseline up to 24 months

• Clinical benefit rate (CBR)

  Baseline up to 24 months

• Duration of Response (DOR)

  Baseline up to 24 months

Study Arms (2)

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.

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.

Drug: TQB3616-matching placebo; Drug: Fluvestrin injection

Interventions

TQB3616 capsules DRUG

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 capsules plus fulvestrant

TQB3616-matching placebo DRUG

The dose of placebo is 180mg, taken orally on an empty stomach, once a day for 28 consecutive days as one treatment cycle.

TQB3616-matching placebo plus fulvestrant

Fluvestrin injection DRUG

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.

TQB3616 capsules plus fulvestrant; TQB3616-matching placebo plus fulvestrant

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• The subjects voluntarily joined the study and signed the informed consent, with good compliance.
• Age: 18-75 years old (upon signing the informed consent);ECOG PS score: 0\~1; Expected survival ≥3 months.
• participants with estrogen receptor-positive, HER2-Negative Advanced Breast Cancer were identified by pathological testing.
• Patients at the relapse/metastatic stage were allowed to receive no more than 1 line of rescue chemotherapy or rescue endocrine therapy.
• Confirmation of at least one measurable lesion according to RECIST1.1 criteria.
• 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%.

You may not qualify if:

• 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；
• Have a history of immunodeficiency, including HIV positive or other acquired or congenital immunodeficiency diseases, or have a history of organ transplantation;
• 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).
• Known to be allergic to fluvestone, TQB3616 or any excipient.
• Participated in clinical trials of other antitumor drugs within 4 weeks prior to the initiation of study therapy.
• Has other conditions that make it inappropriate for the patient to be enrolled based on investigator's opinion.

Sponsors & Collaborators

• Chia Tai Tianqing Pharmaceutical Group Co., Ltd.: lead

Study Sites (2)

The Fifth Medical Center of PLA General Hospital

Beijing, Beijing Municipality, 100039, China

Location

Beijing Cancer Hosptital

Beijing, Beijing Municipality, 100142, China

Location

Related Publications (2)

• 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.

  PMID: 41413016 DERIVED

• 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.

  PMID: 38670537 DERIVED

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 11, 2022
• First Posted: May 16, 2022
• Study Start: March 18, 2022
• Primary Completion: January 16, 2024
• Study Completion: December 9, 2025
• Last Updated: April 8, 2026

Record last verified: 2026-04

Locations

CN (2)