Actively Recruiting
A Study of Chidamide Plus Endocrine in Maintenance Treatment of HR+/HER2- Breast Cancer After First-line Chemotherapy
Led by Tianjin Medical University Cancer Institute and Hospital · Updated on 2023-06-06
60
Participants Needed
1
Research Sites
176 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
To explore the efficacy and safety of Chidamide combined with endocrine for maintenance therapy after first-line chemotherapy for HR+/HER2- breast cancer
CONDITIONS
Official Title
A Study of Chidamide Plus Endocrine in Maintenance Treatment of HR+/HER2- Breast Cancer After First-line Chemotherapy
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Female patients aged 18 to 70 years
- Confirmed HR positive, HER2 negative breast cancer by histology
- Locally advanced, recurrent, or metastatic breast cancer confirmed by tissue tests
- Untreated advanced stage or previously treated with CDK4/6 inhibitors plus endocrine therapy
- Completed 4 to 8 cycles of first-line chemotherapy with disease stable or improved
- At least one measurable lesion based on RECIST v1.1 criteria
- ECOG performance status of 0 to 2
- Acute toxic reactions from prior anti-cancer therapy reduced to grade 0 or 1 excluding hair loss
- Adequate bone marrow function: neutrophils ≥1.5 x 10^9/L, platelets ≥100 x 10^9/L, hemoglobin ≥90 g/L
- Adequate liver and kidney function within specified limits
- Voluntary participation with signed informed consent
You will not qualify if you...
- Difficulty swallowing or conditions affecting oral drug absorption such as chronic diarrhea or intestinal obstruction
- Previous treatment with HDAC inhibitors for cancer
- Known allergy to study drugs
- Other malignant tumors within the past 5 years except certain cured skin or cervical cancers
- Participation in other clinical trials within 4 weeks before enrollment
- History of immune deficiency, positive HIV test, or history of organ transplant
- Uncontrolled significant cardiovascular disease including long QT, severe heart failure, unstable angina, or recent myocardial infarction
- Pregnant or breastfeeding women, or unwillingness to use effective contraception during and 8 weeks after treatment
- Serious conditions judged by researchers that may endanger patient safety
- History of neurological or psychiatric disorders such as epilepsy or dementia
- Active hepatitis B or C infection above specified viral load
- Any 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
天津市肿瘤医院
Tianjin, China
Actively Recruiting
Research Team
L
Li Zhang
CONTACT
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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