Actively Recruiting
A Clinical Study of HRS-6209 Combined With Other Treatment Regimens in Patients With Breast Cancer
Led by Jiangsu HengRui Medicine Co., Ltd. · Updated on 2025-12-30
80
Participants Needed
1
Research Sites
27 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This is a study to evaluate the safety, tolerability, and pharmacokinetic characteristics of HRS-6209 combined with other treatment regimens in breast cancer patients, and preliminarily observe its anti-tumor efficacy.
CONDITIONS
Official Title
A Clinical Study of HRS-6209 Combined With Other Treatment Regimens in Patients With Breast Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Women aged 18-75 years
- ECOG performance status of 0-1
- Menopausal status
- Evidence of radiographic disease progression during or after last systemic anti-tumor therapy before starting study drug
- At least one measurable extracranial lesion at baseline meeting RECIST v1.1 criteria
- Expected survival longer than 3 months
- Women of childbearing potential must agree to use effective contraception during treatment and for 6 months after
- Negative serum HCG test within 7 days before enrollment for women of childbearing potential
- Not breastfeeding
- Willing and able to comply with study visits and procedures and have signed informed consent form
You will not qualify if you...
- Symptomatic visceral metastasis or other conditions unsuitable for endocrine therapy
- History of serious cardiovascular disease
- Abnormal ECG examination
- Clinically significant endometrial abnormalities, including endometrial hyperplasia or dysfunctional uterine bleeding
- Acute infection or active tuberculosis requiring treatment
- Surgery, chemotherapy, immunotherapy, or macromolecular targeted therapy within 4 weeks before first medication
- Pregnant or lactating women, or intending to become pregnant during the study
- History of neurological or mental disorders, psychotropic drug abuse, or drug abuse
- Expected to receive other anti-tumor treatments or drugs during the study
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Tianjin Medical University Cancer Institute and Hospital
Tianjin, Tianjin Municipality, China, 300060
Actively Recruiting
Research Team
X
Xiaoyu Zhu
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
2
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