Actively Recruiting
Chidamide/Everolimus for PIK3CA Wild-type/Mutant HR+/HER2- Advanced Breast Cancer
Led by Cancer Institute and Hospital, Chinese Academy of Medical Sciences · Updated on 2023-08-09
102
Participants Needed
1
Research Sites
208 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
To explore the efficacy and safety of chidamide combined with endocrine in phosphoinositide-3-kinase,catalytic,alpha gene(PI3KCA) wild type hormone receptor positive(HR+)/human epidermal growth factor receptor 2 negative (HER2-) advanced breast cancer patients and to explore the efficacy and safety of Everolimus combined with endocrine therapy in patients with PI3KCA Mutant HR+/HER2- advanced breast cancer.
CONDITIONS
Official Title
Chidamide/Everolimus for PIK3CA Wild-type/Mutant HR+/HER2- Advanced Breast Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Female patients aged between 18 and 75 years
- Hormone receptor-positive breast cancer with ER expression 3 10% and HER2 negative confirmed by histology
- Locally advanced or recurrent/metastatic breast cancer without radical local treatment
- Previous progression after first or second-line treatment with CDK4/6 inhibitors plus endocrine therapy
- PIK3CA gene mutation status determined (mutant enrolled in cohort A; wild-type in cohort B)
- At least one measurable primary lesion before enrollment
- Eastern Oncology Collaborative Group (ECOG) performance status 0-2
- Side effects from prior anti-tumor therapy resolved to grade 0-1 (except hair loss)
- Adequate organ function including blood counts, liver and kidney function, cardiac function (LVEF 3 50%), and ECG within acceptable limits
- Expected survival time of at least 3 months
- Willing and able to provide written informed consent
You will not qualify if you...
- Prior treatment with mTOR or HDAC inhibitors
- Received chemotherapy, targeted therapy, immunotherapy, or other systemic anti-tumor treatments within 4 weeks before study drug start, or radiotherapy within 3 weeks
- Major surgery or significant trauma within 4 weeks before enrollment or planned major surgery
- Brain or subdural metastases unless stable for at least 4 weeks or asymptomatic
- Serious concurrent diseases such as severe hypertension, thyroid disease, hyperlipidemia, active infection
- Poorly controlled diabetes
- Significant gastrointestinal issues affecting drug intake or absorption
- Severe cardiovascular disease including recent heart attack or severe arrhythmia
- Active hepatitis B or C infection or known HIV positive status
- Pregnancy, lactation, or unwillingness to use effective contraception during and 90 days after the study
- History of neurological or mental disorders including epilepsy or dementia
- Any other condition deemed unsuitable by the investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College
Beijing, Beijing Municipality, China, 100021
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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