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

Primary Purpose

HR+/HER2- Breast Cancer

Status
Recruiting
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Tucidinostat
nab-paclitaxel
Sponsored by
Hunan Cancer Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for HR+/HER2- Breast Cancer

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

  • Hunan Cancer HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Tucidinostat and nab-paclitaxel

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
November 21, 2022
Last Updated
February 17, 2023
Sponsor
Hunan Cancer Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05633914
Brief Title
Tucidinostat and Nab-paclitaxel in Advanced HR+/HER2- Breast Cancer
Official Title
A Phase II Study of Tucidinostat and Nab-paclitaxel in Advanced HR+/HER2- Breast Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 7, 2023 (Actual)
Primary Completion Date
December 1, 2024 (Anticipated)
Study Completion Date
December 1, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hunan Cancer Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HR+/HER2- Breast Cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
90 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Tucidinostat and nab-paclitaxel
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Tucidinostat
Other Intervention Name(s)
Chidamide
Intervention Description
20mg, po., biw, q3w
Intervention Type
Drug
Intervention Name(s)
nab-paclitaxel
Other Intervention Name(s)
ABRAXANE
Intervention Description
125mg/m2, d1, iv.drip, q7d
Primary Outcome Measure Information:
Title
Objective Response Rate(ORR)
Description
ORR by RECIST 1.1,the total proportion of patients with complete response(CR), partial response(PR)
Time Frame
2 years
Secondary Outcome Measure Information:
Title
Progression-free survival(PFS)
Description
Time from treatment until disease progression or death
Time Frame
2 years
Title
Disease Control Rate (DCR)
Description
the total proportion of patients with complete response(CR), partial response(PR)and Stable Disease(SD)
Time Frame
2 years
Title
Disease Control Rate (DCR)
Description
Time from treatment until death from any cause
Time Frame
2 years

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
quchang ouyang, MD, PhD
Phone
0731-89762160
Email
oyqc1969@126.com
Facility Information:
Facility Name
Hunan Cancer Hospital
City
Changsha
State/Province
Hunan
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
quchang ouyang
Phone
0731-89762160
Email
oyqc1969@126.com

12. IPD Sharing Statement

Plan to Share IPD
No

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

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