Actively Recruiting
SNF Platform Study of HR+/ HER2-advanced Breast Cancer
Led by Fudan University · Updated on 2024-10-04
620
Participants Needed
1
Research Sites
204 weeks
Total Duration
On this page
Sponsors
F
Fudan University
Lead Sponsor
P
Peking University Cancer Hospital & Institute
Collaborating Sponsor
AI-Summary
What this Trial Is About
The purpose of this study is to establish a prospective, multi-center platform research based on clinical subtypes to explore precision therapy in patients hormone-receptor-positive HER2-negative advanced breast cancer who had previously used CDK4/6 inhibitors.
CONDITIONS
Official Title
SNF Platform Study of HR+/ HER2-advanced Breast Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Female aged 18 years or older
- Confirmed hormone-receptor-positive, HER2-negative invasive breast cancer by histology (ER >10% or PR >10% positive tumor cells; HER2 0-1+ or HER2+ but negative by FISH)
- Locally advanced breast cancer not suitable for radical local treatment or recurrent metastatic breast cancer
- Previously treated with CDK4/6 inhibitor therapy
- At least one measurable lesion per RECIST 1.1 criteria (CT scan lesion ≥20 mm or spiral CT scan lesion ≥10 mm, untreated by radiotherapy)
- Normal major organ function meeting specified blood counts and biochemical test criteria
- No radiotherapy, molecular targeted therapy, or surgery within 3 weeks before study start and recovered from acute toxicity
- ECOG performance status 0 to 2 and life expectancy of at least 3 months
- Fertile females agree to use approved contraception during treatment and for at least 3 months after last study drug use
- Voluntary consent to participate, good compliance, and willingness to follow up
You will not qualify if you...
- Received radiotherapy (except palliative), chemotherapy, or immunotherapy within 3 weeks before treatment start, except bisphosphonates for bone metastasis
- Uncontrolled or symptomatic central nervous system metastases requiring glucocorticoids or mannitol
- History of significant or uncontrolled heart disease within the past 6 months
- Ongoing grade 1 or higher adverse reactions from previous treatments, except hair loss or conditions not requiring exclusion
- Major surgery within 3 weeks before first treatment dose (minor outpatient procedures allowed)
- Pregnant or breastfeeding
- Other malignancies within the past 5 years except cured basal cell carcinoma of the skin or carcinoma in situ of the cervix
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Breast cancer institute of Fudan University Cancer Hospital
Shanghai, Shanghai Municipality, China, 200032
Actively Recruiting
Research Team
Z
Zhimin Shao, M.D
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
26
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