Actively Recruiting
Clinical Study of HRS-8080 in Combination With Dalpiciclib Isethionate Tablets in Patients With Unresectable or Metastatic Breast Cancer
Led by Shandong Suncadia Medicine Co., Ltd. · Updated on 2026-01-09
146
Participants Needed
2
Research Sites
127 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This is a multicenter, open phase Ib/II clinical study, which is divided into two phases: dose exploration and efficacy expansion. Participants entering the study will receive HRS-8080 combined with Dalpiciclib Isethionate Tablets therapy.
CONDITIONS
Official Title
Clinical Study of HRS-8080 in Combination With Dalpiciclib Isethionate Tablets in Patients With Unresectable or Metastatic Breast Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Women aged 18 to 75 years
- ECOG physical status of 0 or 1
- Histologically confirmed metastatic or locally advanced breast cancer
- Dose-exploration stage: advanced stage with at least 1 prior line of endocrine therapy progression
- Efficacy expansion stage: no prior systemic treatment for advanced disease
- Radiographic confirmation of disease progression or receiving first-line standard endocrine therapy without progression
- At least one measurable extracranial lesion
- Expected survival longer than 3 months
- Adequate organ function as required by the study
- Fertile females must use highly effective contraception during and for 7 months after treatment, have negative serum HCG within 7 days before enrollment, and be non-lactating
- Voluntary participation with ability to comply with study procedures and signed informed consent
You will not qualify if you...
- Symptoms of visceral metastasis
- Previous treatment not meeting study requirements
- Received nitrosourea or mitomycin within 6 weeks prior to first dose
- Major organ surgery, cytotoxic drugs, immunotherapy, targeted therapy, traditional Chinese medicine, or other investigational drugs within 4 weeks prior to first dose
- Endocrine therapy or palliative radiotherapy within 2 weeks prior to first dose
- Treatment with strong CYP3A4 inducer within 14 to 28 days prior to first dose
- Active brain metastases, cancerous meningitis, spinal cord compression, or primary CNS tumors
- History of severe cardiovascular disease
- Uncontrolled tumor-related pain
- Immunosuppressive agents or systemic hormone therapy for immunosuppression within 2 weeks prior to first dose
- Recovery not complete from prior treatment-related damage
- Severe infection within 4 weeks prior to second dose
- Arteriovenous thrombosis within 6 months prior to medication
- Clinically significant endometrial abnormalities
- Untreated active hepatitis
- Other malignancies within past 5 years or currently
- Inherited or acquired bleeding disorders
- History of active autoimmune or immune deficiency diseases
- Factors affecting oral medication intake
- Active infections requiring medication including tuberculosis
- Known allergy to HRS-8080, Dalpiciclib, or their ingredients
- Pregnant, lactating, or planning pregnancy during the study
- History of neurological or psychiatric disorders or substance abuse
- Other serious illnesses or lab abnormalities increasing risk or affecting study participation, as judged by investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 2 locations
1
Chinese PLA General Hospital Fifth Medical Center
Beijing, Beijing Municipality, China, 100000
Actively Recruiting
2
Sun Yat-sen University Cancer Center (SYSUCC)
Guangzhou, Guangdong, China, 510060
Actively Recruiting
Research Team
M
Min Li
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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