Actively Recruiting
Study of HRS-8080 or SHR-A2009 Combined With Anti-tumor Therapy in Patients With Unresectable or Metastatic Breast Cancer
Led by Shandong Suncadia Medicine Co., Ltd. · Updated on 2024-11-25
350
Participants Needed
1
Research Sites
140 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This study is designed to determine if treatments with the combination of HRS-8080 and SHR-A1811, the combination of HRS-8080 and SHR-A2009, the combination of SHR-A2009 and SHR-1316 are safe, tolerable, and has anti-cancer activity in patients with unresectable or metastatic breast cancer.
CONDITIONS
Official Title
Study of HRS-8080 or SHR-A2009 Combined With Anti-tumor Therapy in Patients With Unresectable or Metastatic Breast Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Female aged 18 to 75 years
- ECOG performance status 0 to 1
- Metastatic or locally advanced breast cancer confirmed by histology (ER positive, HER2 positive/negative, or triple negative breast cancer)
- Provide tumor tissue samples for tumor marker detection
- Menopausal status
- Disease progression confirmed by imaging during or after last systemic treatment
- At least one measurable extracranial lesion per RECIST v1.1
- Expected survival longer than 3 months
- Good organ function
- Female subjects with childbearing potential must agree to use highly effective contraception during and for 7 months after study treatment and have a negative HCG test within 7 days before enrollment
- Voluntarily agree to participate and comply with study procedures and visits with signed informed consent
You will not qualify if you...
- Active brain metastasis without medical control or symptoms
- History of lung diseases
- History of severe cardiovascular disease
- Received immunosuppressants or systemic hormone therapy for immunosuppression within 2 weeks before first dose (excluding nasal or inhaled hormones)
- Unrecovered damage from prior treatments (NCI-CTCAE V5.0 grade >1, excluding hair loss and tolerable adverse events)
- Serious infections within 4 weeks before first medication
- Untreated active hepatitis
- Other malignant tumors within past 5 years or currently, except cured cervical carcinoma in situ and some skin cancers
- Active autoimmune disease
- History of immunodeficiency or organ transplantation
- Acute infection or active tuberculosis requiring treatment
- Allergic to study drug components or have severe allergic reactions to monoclonal antibodies
- Other serious physical or mental illnesses or lab abnormalities that increase study risk or interfere with results as judged by researcher
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Hunan Cancer Hospital
Changsha, Hunan, China, 410031
Actively Recruiting
Research Team
N
Na An
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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