Actively Recruiting
Adebrelimab Combined With Dalpiciclib and Standard Endocrine Therapy for HR+/HER2 - Advanced Breast Cancer
Led by Tongji Hospital · Updated on 2024-04-15
82
Participants Needed
1
Research Sites
150 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This is a prospective, single-arm, multicenter Phase II study of patients with advanced HR+/HER2- breast cancer who are untreated or have failed previous first-line endocrine therapy。The primary objective of this study was to explore the efficacy and safety of the PD-L1 inhibitor adebrelimab in combination with the CDK4/6 inhibitor Dalpiciclib and standard endocrine therapy in advanced HR+/ HER2-breast cancer.
CONDITIONS
Official Title
Adebrelimab Combined With Dalpiciclib and Standard Endocrine Therapy for HR+/HER2 - Advanced Breast Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Female patients aged 18 to 75 years, premenopausal, perimenopausal, or postmenopausal
- Histologically confirmed HR+/HER2- invasive breast cancer
- Locally advanced or recurrent metastatic breast cancer not suitable for radical local treatment
- No systemic anti-cancer therapy at recurrence/metastasis stage or failed first-line endocrine therapy
- Allowed to have received one or fewer lines of chemotherapy
- At least one measurable lesion according to RECIST version 1.1
- Adequate blood counts and organ function as specified (including hemoglobin >9 g/dL, ANC ≥1.5×10⁹/L, platelets ≥75×10⁹/L, liver and kidney function within limits)
- ECOG performance status of 0 or 1 and life expectancy of at least 3 months
- Fertile women must use medically approved contraception during treatment and for 3 months after last dose
- Willingness to participate, sign informed consent, comply with study and follow-up
You will not qualify if you...
- Previous treatment with CDK4/6 inhibitors or PD1/PD-L1 monoclonal antibodies
- Uncontrolled central nervous system metastases requiring symptom control
- Significant or uncontrolled heart disease including recent myocardial infarction or arrhythmias
- Radiotherapy, surgery, or other targeted/immunotherapy within 4 weeks before first study drug dose
- Pregnant or breastfeeding
- Malignant tumors within the past 3 years except cured basal cell carcinoma and cervical carcinoma in situ
- Significant comorbidities or mental illnesses impacting study participation
- Recent anti-tumor or live vaccine within 4 weeks prior to study drug
- Active hepatitis B or C infection or abnormal liver function related to these infections
- History of active autoimmune disease or immunodeficiency conditions
- History of interstitial lung disease or non-infectious pneumonia
- Active infection or recent immune stimulating factor treatment within 4 weeks
- Known allergy to study drugs or other monoclonal antibodies
- Previous thyroid dysfunction
- Any other condition deemed unsuitable by the investigator for participation
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Tongji Hospital Affiliated of Tongji Medical College Huazhong University of Science and Technology
Wuhan, Hubei, China, 430000
Actively Recruiting
Research Team
X
Xiong huihua
CONTACT
C
Chao tengfei
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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