To hear about similar clinical trials, please enter your email below
Trial Title:
Tucidinostat and Nab-paclitaxel in Advanced HR+/HER2- Breast Cancer
NCT ID:
NCT05633914
Condition:
HR+/HER2- Breast Cancer
Conditions: Official terms:
Breast Neoplasms
Paclitaxel
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Tucidinostat
Description:
20mg, po., biw, q3w
Arm group label:
Tucidinostat and nab-paclitaxel
Other name:
Chidamide
Intervention type:
Drug
Intervention name:
nab-paclitaxel
Description:
125mg/m2, d1, iv.drip, q7d
Arm group label:
Tucidinostat and nab-paclitaxel
Other name:
ABRAXANE
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.
Criteria for eligibility:
Criteria:
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.
Gender:
Female
Minimum age:
18 Years
Maximum age:
75 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Hunan Cancer Hospital
Address:
City:
Changsha
Country:
China
Status:
Recruiting
Contact:
Last name:
quchang ouyang
Phone:
0731-89762160
Email:
oyqc1969@126.com
Start date:
February 7, 2023
Completion date:
December 1, 2025
Lead sponsor:
Agency:
Hunan Cancer Hospital
Agency class:
Other
Source:
Hunan Cancer Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05633914
