Status:
UNKNOWN
A Trial of HRS-8080 Tablets in Metastatic or Local Advanced Breast Cancer of Adults
Lead Sponsor:
Shandong Suncadia Medicine Co., Ltd.
Conditions:
Metastatic or Local Advanced Breast Cancer of Patients
Eligibility:
FEMALE
18-75 years
Phase:
PHASE1
Brief Summary
The study is being conducted to evaluate the tolerance, and safety of HRS-8080 tablets monotherapy and combined with other anti-cancer therapy for metastatic or local advanced breast cancer in adults....
Eligibility Criteria
Inclusion
- ECOG performance status score: 0-1;
- Histopathologically documented local advanced or metastatic breast cancer ;
- Female of not childbearing potential must the related requirement;
- During or after the last systematic therapy before enrolment, disease progression occurred with clinical or radiographical documentation;
- Adequate organ functions as defined;
- Ability to understand and voluntarily agrees to participate by giving written informed consent for the study.
Exclusion
- For the case of symptomatic visceral metastasis, the investigators judged that it was not suitable to use relevant treatment;
- patients with active brain metastasis (without medical control or with clinical symptoms), cancerous meningitis, spinal cord compression, or patients with a history of primary tumors of the central nervous system ;
- History of clinically significant cardiovascular or cerebrovascular diseases;
- The subject has one of many factors affecting oral drugs;
- Active infection or fever with unknown cause \> 38.5 °C;
- Active autoimmune diseases, History of immunodeficiency, including positive HIV serum test result and other acquired or congenital immunodeficiency diseases, or history of organ transplantation;
- Known history of allergy to study drug ingredients.
Key Trial Info
Start Date :
February 17 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 31 2025
Estimated Enrollment :
156 Patients enrolled
Trial Details
Trial ID
NCT05189717
Start Date
February 17 2022
End Date
July 31 2025
Last Update
April 5 2022
Active Locations (2)
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1
Fifth Medical Center of People's Liberation Army of China General Hospital
Beijing, Beijing Municipality, China, 100071
2
Jilin Cancer Hospital
Changchun, Jilin, China, 130012