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

NCT05633914 | Unknown Phase 2

• 1 other identifier: CSIIT-C34
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

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.

Conditions

HR+/HER2- Breast Cancer

Outcome Measures

Primary Outcomes (1)

• Objective Response Rate（ORR）

  ORR by RECIST 1.1,the total proportion of patients with complete response（CR）, partial response（PR）

  2 years

Secondary Outcomes (3)

• Progression-free survival(PFS)

  2 years

• Disease Control Rate （DCR）

  2 years

• Disease Control Rate （DCR）

  2 years

Study Arms (1)

Tucidinostat and nab-paclitaxel

EXPERIMENTAL

Drug: Tucidinostat; Drug: nab-paclitaxel

Interventions

Tucidinostat DRUG

20mg, po., biw, q3w

Also known as: Chidamide

Tucidinostat and nab-paclitaxel

nab-paclitaxel DRUG

125mg/m2, d1, iv.drip, q7d

Also known as: ABRAXANE

Tucidinostat and nab-paclitaxel

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hunan Cancer Hospital: lead

Study Sites (1)

Hunan Cancer Hospital

Changsha, Hunan, China

RECRUITING

MeSH Terms

Interventions

N-(2-amino-5-fluorobenzyl)-4-(N-(pyridine-3-acrylyl)aminomethyl)benzamide; 130-nm albumin-bound paclitaxel; Albumin-Bound Paclitaxel

Intervention Hierarchy (Ancestors)

Paclitaxel; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Albumins; Proteins; Amino Acids, Peptides, and Proteins

Central Study Contacts

quchang ouyang, MD, PhD

CONTACT

0731-89762160; oyqc1969@126.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 21, 2022
• First Posted: December 1, 2022
• Study Start: February 7, 2023
• Primary Completion: December 1, 2024
• Study Completion: December 1, 2025
• Last Updated: February 21, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)