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

Hunan Cancer Hospital1 site in 1 country90 target enrollmentFebruary 7, 2023

ConditionsHR+/HER2- Breast Cancer

InterventionsTucidinostat nab-paclitaxel

DrugsTucidinostat nab-paclitaxel

Overview

Phase: Phase 2
Intervention: Tucidinostat
Conditions: HR+/HER2- Breast Cancer
Sponsor: Hunan Cancer Hospital
Enrollment: 90
Locations: 1
Primary Endpoint: Objective Response Rate（ORR）
Status: Recruiting
Last Updated: 3 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

February 7, 2023

End Date

December 1, 2025

Last Updated

3 years ago

Study Type

Interventional

Study Design

Single Group

Sex

Female

Investigators

Sponsor

Hunan Cancer Hospital

Responsible Party

Sponsor

Eligibility Criteria

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.