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

NCT ID: NCT05633914

Last Updated: 2023-02-21

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 90 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-02-07
• Study Completion Date: 2025-12-01

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Tucidinostat and nab-paclitaxel

Group Type: EXPERIMENTAL

Tucidinostat

Intervention Type: DRUG

20mg, po., biw, q3w

nab-paclitaxel

Intervention Type: DRUG

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

Interventions

Tucidinostat

20mg, po., biw, q3w

Intervention Type: DRUG

nab-paclitaxel

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

Intervention Type: DRUG

Other Intervention Names

Chidamide; ABRAXANE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Hunan Cancer Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Hunan Cancer Hospital

Changsha, Hunan, China

Site Status: RECRUITING

Countries

China

Central Contacts

quchang ouyang, MD, PhD

Role: CONTACT

oyqc1969@126.com

0731-89762160

Facility Contacts

quchang ouyang

Role: primary

oyqc1969@126.com

0731-89762160

Other Identifiers

CSIIT-C34

Identifier Type: -

Identifier Source: org_study_id