Actively Recruiting
A Study of HRS-6208 in Combination With HRS-8080, or Fulvestrant, or Letrozole, With or Without HRS-6209 in Patients With Advanced Unresectable or Metastatic Breast Cancer
Led by Shandong Suncadia Medicine Co., Ltd. · Updated on 2026-04-03
180
Participants Needed
2
Research Sites
140 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This study aims to evaluate the safety, tolerability, efficacy and pharmacokinetics of HRS-6208 in combination with HRS-8080 ± HRS-6209, or in combination with fulvestrant ± HRS-6209, or in combination with letrozole ± HRS-6209 in patients with advanced unresectable or metastatic breast cancer.
CONDITIONS
Official Title
A Study of HRS-6208 in Combination With HRS-8080, or Fulvestrant, or Letrozole, With or Without HRS-6209 in Patients With Advanced Unresectable or Metastatic Breast Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Female, aged 18 to 75 years inclusive
- ECOG performance status score of 0 to 1
- Estimated survival time of at least 12 weeks
- Adequate bone marrow and organ function
- Women of reproductive potential agree to use effective contraception during treatment and for 2 years after last dose
- Willing and able to provide written informed consent before participation
You will not qualify if you...
- Other cancers within 5 years prior to first dose, except treated cervical carcinoma in situ, basal or squamous cell skin cancer, and treated thyroid papillary carcinoma
- Active brain metastasis, carcinomatous meningitis, spinal cord compression, or history of primary CNS tumors
- Severe bone damage from tumor bone metastasis
- Unresolved adverse events from prior anti-tumor treatments
- Conditions affecting oral medication intake
- History of severe cardiovascular or cerebrovascular diseases
- Presence of severe infections
- Significant bleeding within 3 months before first dose
- Active autoimmune diseases, immune deficiency, or history of diseases requiring systemic steroids or immunosuppressants
- Active untreated hepatitis
- History of active tuberculosis within 1 year, or untreated past tuberculosis
- Insufficient washout period from prior treatments
- Prior use of prohibited drugs listed in protocol
- Pregnant, breastfeeding, or planning pregnancy within 2 years after last dose
- History of neurological or psychiatric disorders, psychiatric drug abuse, or drug addiction
- Allergic reactions to study drugs or excipients
- Any other factors deemed unsuitable by investigator
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 2 locations
1
The Second Affiliated Hospital of Dalian Medical University
Dalian, Liaoning, China, 116031
Actively Recruiting
2
West China Hospital, Sichuan University
Chengdu, Sichuan, China, 610044
Actively Recruiting
Research Team
Y
Yunxia Feng
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
3
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