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

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

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.

Study Overview

• Status: Recruiting
• Conditions: HR+/HER2- Breast Cancer
• Intervention / Treatment: Drug: Tucidinostat; Drug: nab-paclitaxel

• Study Type: Interventional
• Enrollment (Anticipated): 90
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: quchang ouyang, MD, PhD; Phone Number: 0731-89762160; Email: oyqc1969@126.com

Study Locations

• China
  • Hunan
    • Changsha, Hunan, China
      • Recruiting
      • Hunan Cancer Hospital
      • Contact: quchang ouyang; Phone Number: 0731-89762160; Email: oyqc1969@126.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Hunan Cancer Hospital

Study record dates

Study Major Dates

• Study Start (Actual): February 7, 2023
• Primary Completion (Anticipated): December 1, 2024
• Study Completion (Anticipated): December 1, 2025

Study Registration Dates

• First Submitted: November 21, 2022
• First Submitted That Met QC Criteria: November 21, 2022
• First Posted (Actual): December 1, 2022

Study Record Updates

• Last Update Posted (Estimate): February 20, 2023
• Last Update Submitted That Met QC Criteria: February 17, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms; Molecular Mechanisms of Pharmacological Action; Antineoplastic Agents; Tubulin Modulators; Antimitotic Agents; Mitosis Modulators; Antineoplastic Agents, Phytogenic; Paclitaxel
• Other Study ID Numbers: CSIIT-C34

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No