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

Sponsor
Hunan Cancer Hospital (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05633914
Collaborator
(none)
90
Enrollment
1
Arm
36
Anticipated Duration (Months)

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
Phase 2

Study Design

Study Type:
Interventional
Anticipated Enrollment :
90 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Phase II Study of Tucidinostat and Nab-paclitaxel in Advanced HR+/HER2- Breast Cancer
Anticipated Study Start Date :
Dec 1, 2022
Anticipated Primary Completion Date :
Dec 1, 2024
Anticipated Study Completion Date :
Dec 1, 2025

Arms and Interventions

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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Objective Response Rate（ORR） [2 years]

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

    Secondary Outcome Measures

    1. Progression-free survival(PFS) [2 years]

      Time from treatment until disease progression or death

    2. Disease Control Rate （DCR） [2 years]

      the total proportion of patients with complete response（CR）, partial response（PR）and Stable Disease（SD）

    3. Disease Control Rate （DCR） [2 years]

      Time from treatment until death from any cause

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 75 Years
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Hunan Cancer Hospital

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Hunan Cancer Hospital
    ClinicalTrials.gov Identifier:
    NCT05633914
    Other Study ID Numbers:
    • CSIIT-C34
    First Posted:
    Dec 1, 2022
    Last Update Posted:
    Dec 1, 2022
    Last Verified:
    Nov 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Breast Neoplasms
    Paclitaxel

    Study Results

    No Results Posted as of Dec 1, 2022