Tucidinostat and Nab-paclitaxel in Advanced HR+/HER2- Breast Cancer

Study Overview
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Brief Summary
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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.

Official Title
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A Phase II Study of Tucidinostat and Nab-paclitaxel in Advanced HR+/HER2- Breast Cancer

Conditions
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HR+/HER2- Breast Cancer

Intervention / Treatment
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* Drug: Tucidinostat
* Drug: nab-paclitaxel


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age≥18 years, ≤75, female; 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%]; Primary endocrine resistance or at least experienced one line of endocrine therapy for recurrent or metastatic disease; No more than 1 prior line of chemothrapy for recurrent or metastatic disease; 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; ECOG performance status ≤ 1; At least one measurable disease based on RECIST v1.1 Adequate organ function; Life expectancy is more than 3 months; Willing and able to provide written informed consent. Exclusion Criteria: Prior exposed to histone deacetylase inhibitors, or received taxanes for metastatic disease; Known hypersensitivity to any formulation component of the study drug; 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; 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); Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis. Pregnant or lactating female. Any other conditions deemed inappropriate by the investigator to participate in this study.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Tucidinostat and nab-paclitaxel<br> | Drug: Tucidinostat<br>* 20mg, po., biw, q3w<br>* Other names: Chidamide;Drug: nab-paclitaxel<br>* 125mg/m2, d1, iv.drip, q7d<br>* Other names: ABRAXANE;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Objective Response Rate（ORR） | ORR by RECIST 1.1,the total proportion of patients with complete response（CR）, partial response（PR） | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression-free survival(PFS) | Time from treatment until disease progression or death | 2 years | 
| Disease Control Rate （DCR） | the total proportion of patients with complete response（CR）, partial response（PR）and Stable Disease（SD） | 2 years | 
| Disease Control Rate （DCR） | Time from treatment until death from any cause | 2 years |