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Evaluation of TQB3616 Capsules in a Phase II Clinical Trial for Recurrent/Metastatic Breast Cancer
Sponsor: Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
Summary
Evaluation of the Efficacy and Safety of TQB3616 Capsules Combined with Hormonal Therapy in a Phase II Clinical Trial for Cyclin-dependent Kinases 4 and 6 (CDK4/6) Inhibitor-Resistant, HR-Positive, HER2-Negative Recurrent/Metastatic Breast Cancer.
Official title: Evaluation of the Efficacy and Safety of TQB3616 Capsules Combined With Hormonal Therapy in a Phase II Clinical Trial for Cyclin-dependent Kinases 4 and 6(CDK4/6)Inhibitor-Resistant, Hormone Receptor(HR)-Positive, Human Epidermal Growth Factor Receptor 2(HER2)-Negative Recurrent/Metastatic Breast Cancer
Key Details
Gender
All
Age Range
18 Years - 75 Years
Study Type
INTERVENTIONAL
Enrollment
33
Start Date
2025-02-20
Completion Date
2026-12
Last Updated
2026-04-09
Healthy Volunteers
No
Conditions
Interventions
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.
Locations (13)
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