Evaluation of TQB3616 Capsules in a Phase II Clinical Trial for Recurrent/Metastatic Breast Cancer
NCT ID: NCT06702618
Last Updated: 2024-12-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
NOT_YET_RECRUITING
PHASE2
33 participants
INTERVENTIONAL
2025-01-31
2026-12-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
TQB3616 capsule+Fulvestrant Injection
TQB3616 capsule+Fulvestrant Injection
TQB3616 capsule is a CDK2/4/6 inhibitor and Fulvestrant injection is an anti-estrogen medication, and its pharmacological mechanism mainly exerts its therapeutic effect by inhibiting the action of aromatase.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
TQB3616 capsule+Fulvestrant Injection
TQB3616 capsule is a CDK2/4/6 inhibitor and Fulvestrant injection is an anti-estrogen medication, and its pharmacological mechanism mainly exerts its therapeutic effect by inhibiting the action of aromatase.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Aged 18 to 75 years, with an Eastern Cooperative Oncology Group Performance Status (ECOG PS) score of 0\~1; expected survival time of more than 3 months.
* Postmenopausal or premenopausal/perimenopausal female patients
* Progressed after prior treatment with CDK4/6 inhibitors
* At least one measurable lesion according to Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria
* Good major organ function
* Women of childbearing potential must agree to use contraception during the study and for 6 months after its completion.
Exclusion Criteria
* Subjects with inflammatory breast cancer or occult breast cancer.
* Subjects who have had or currently have other malignant tumors within 5 years prior to randomization.
* Subjects with unresolved toxicity (greater than Common Terminology Criteria for Adverse Events (CTCAE) Grade 1) from prior treatment, excluding alopecia.
* Subjects who have undergone major surgical procedures, incisional biopsies, or significant traumatic injuries within 28 days prior to the first dose.
* Subjects with non-tumor-related unresolved wounds, ulcers, or fractures.
* Subjects with multiple factors affecting oral medication intake and absorption.
* Subjects with arterial or deep vein thrombotic events within 6 months prior to the first dose.
* Subjects with ≥ Grade 2 myocardial ischemia or myocardial infarction, arrhythmia, angina requiring anti-anginal medication, clinically significant valvular heart disease, or uncontrolled hypertension.
* Subjects with a history of interstitial lung disease/pneumonitis (non-infectious) requiring steroid intervention or currently having interstitial lung disease/pneumonitis, or subjects with suspected interstitial lung disease/pneumonitis on screening imaging that cannot be excluded.
* Subjects with active or uncontrolled serious infections (≥CTCAE Grade 2 infection) or unexplained fever \>38.5°C within 28 days prior to the first dose.
* Subjects with a history of abuse of psychotropic drugs that cannot be abstained from or those with psychiatric disorders.
* Subjects with (pseudo) cirrhosis, active hepatitis.
* Subjects with renal failure requiring hemodialysis or peritoneal dialysis.
* Subjects with a history of immunodeficiency diseases, organ transplants, or hematopoietic stem cell transplants.
* Subjects who have previously received fulvestrant or other oral Selective Estrogen Receptor Degrader (SERD) class drugs.
* Subjects who have previously received anti-HER2 therapy.
* Subjects who have previously received antibody-drug conjugate therapy.
* Subjects who have participated in other anti-tumor clinical trials and taken investigational drugs within 4 weeks prior to the first dose.
* Subjects judged by the investigator to have serious accompanying diseases that severely endanger the safety of the subject or affect the completion of the study, or subjects who are deemed unsuitable for enrollment for other reasons
18 Years
75 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
The First Affilliated Hospital of Bengbu Medical University
Bengbu, Anhui, China
Jiangmen Central Hospital
Jiangmen, Guangdong, China
Xingtai People's Hospital
Xingtai, Hebei, China
Harbin Medical University Cancer Hostipal
Harbin, Heilongjiang, China
Luohe Central Hospital
Luohe, Henan, China
Hunan Cancer Hospital
Changsha, Hunan, China
Jiangsu Provincial People's Hospital
Nanjing, Jiangsu, China
Hai'an People's Hospital
Nantong, Jiangsu, China
Liaoning Cancer Hospital
Shenyang, Liaoning, China
Cancer Hospital of Shandong First Medical University(Shandong Cancer Institute, Shandong Cancer Hospital)
Jinan, Shandong, China
The First Affiliated Hospital of Xi'an Jiao Tong University
Xi’an, Shanxi, China
The Affiliated Hospital of Southwest Medical University
Luzhou, Sichuan, China
Tianjin Medical University Cancer Institute & Hospital
Tianjin, Tianjin Municipality, China
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Hongtao Li, Bachelor
Role: primary
Xiaoping Li, Doctor
Role: primary
Li Wang, Doctor
Role: primary
Li Cai, Bachelor
Role: primary
TianJiang Ma, Bachelor
Role: primary
Quchang Ou Yang, Doctor
Role: primary
Yongmei Yin, Doctor
Role: primary
Bo Shen, Doctor
Role: primary
Tao Sun, Doctor
Role: primary
Yongsheng Wang, Doctor
Role: primary
Jin Yang, Doctor
Role: primary
Lijia He, Bachelor
Role: primary
Yehui Shi, Doctor
Role: primary
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
TQB3616-II-04
Identifier Type: -
Identifier Source: org_study_id