HR+/HER2- Breast Cancer
Conditions
Brief summary
This study is looking to see whether the combination of Tucidinostat and nab-paclitaxel is safe and effective in participants with advanced HR+/HER2- breast cancer.
Interventions
DRUGTucidinostat
20mg, po., biw, q3w
DRUGnab-paclitaxel
125mg/m2, d1, iv.drip, q7d
Sponsors
Hunan Cancer Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
1. Age≥18 years, ≤75, female; 2. Histologically confirmed HR positive and HER2 negative postmenopausal metastatic breast cancer patients \[HER2 negative is defined as immunohistochemistry(IHC) 0 or IHC 1+, and if the score of IHC is 2+, fluorescence in situ hybridization technology (FISH) test must be negative, HR positve is defined as ER or PR ≥1%\]; 3. Primary endocrine resistance or at least experienced one line of endocrine therapy for recurrent or metastatic disease; 4. No more than 1 prior line of chemothrapy for recurrent or metastatic disease; 5. Patients who have been exposed to taxanes in neoadjuvant or adjuvant setting will be allowed to enroll, if they have obtained benifits from neoadjuvant treatment or have progressed ≥ 12 months from completion of adjuvant treatment; 6. ECOG performance status ≤ 1; 7. At least one measurable disease based on RECIST v1.1 8. Adequate organ function; 9. Life expectancy is more than 3 months; 10. Willing and able to provide written informed consent.
Exclusion criteria
1. Prior exposed to histone deacetylase inhibitors, or received taxanes for metastatic disease; 2. Known hypersensitivity to any formulation component of the study drug; 3. Received chemotherapy, targeted therapy, Chinese herbal medicine with anti-tumor indications, or immunomodulatory drugs (including thymosin, interferon, interleukin, etc.) within 4 weeks before enrollment, or still within 5 half-lives of such drugs; 4. Toxicities that did not recover to National Cancer Institute Common Adverse Event Terminology Version 5.0 (NCICTCAEv5.0) grade 0 or 1 toxicity from prior antineoplastic therapy prior to the first dose of study treatment(alopecia, grade 2 fatigue, grade 2 anemia, non-clinically critical and asymptomatic laboratory abnormalities can be enrolled); 5. Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis. 6. Pregnant or lactating female. 7. Any other conditions deemed inappropriate by the investigator to participate in this study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Objective Response Rate（ORR） | 2 years | ORR by RECIST 1.1,the total proportion of patients with complete response（CR）, partial response（PR） |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Progression-free survival(PFS) | 2 years | Time from treatment until disease progression or death |
| Disease Control Rate （DCR） | 2 years | the total proportion of patients with complete response（CR）, partial response（PR）and Stable Disease（SD） |
Countries
China
Contacts
Primary Contactquchang ouyang, MD, PhD
Outcome results
None listed