Chidamide Combined With Angiogenesis Inhibitors and Fulvestrant for Advanced HR-positive, HER2-negative Breast Cancer

NCT06750848 | Not Yet Recruiting Phase 2

• 1 other identifier: CSIIT-C31
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

Brief Summary

This Phase Ⅱ study was designed to assess the efficacy and safety of the combination of tucidinostat, angiogenesis inhibitors and fulvestrant for advanced HR-positive, HER2-negative breast cancer patients after the failure of CDK4/6 inhibitor.

Conditions

Advanced Breast Cancer

Outcome Measures

Primary Outcomes (1)

• Objective Response Rate（ORR）

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

  2 years

Secondary Outcomes (4)

• Progression-free survival(PFS)

  2 years

• Disease Control Rate （DCR）

  2 years

• Clinical Benefit Rate (CBR)

  2 years

• Overall survival (OS)

  2 years

Study Arms (1)

Chidamide，Fulvestrant ，angiogenesis inhibitors

EXPERIMENTAL

Drug: Chidamide，Fulvestrant，angiogenesis inhibitors

Interventions

Chidamide，Fulvestrant，angiogenesis inhibitors DRUG

chidamide，30mg，po. biw fulvestrant ，500mg， im., d1(c1d15), q4w angiogenesis inhibitors , according to the doctor's advice

Chidamide，Fulvestrant ，angiogenesis inhibitors

Eligibility Criteria

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

You may qualify if:

• Age≥18 years, ≤75, female; 2.Histologically confirmed HR positive and HER2 negative postmenopausal metastatic breast cancer patients \[HER2 negative is defined as immunohistochemistry(IHC) 0 or IHC 1+, and if the score of IHC is 2+, fluorescence in situ hybridization technology (FISH) test must be negative, HR positve is defined as ER or PR ≥10%\]; 3.Prior CDK4/6 inhibitor progression or intolerance to CDK4/6i before enrollment; 4.Premenopausal patients need OFS; 5.Recurrence and metastasis progressed more than 6 months after receiving endocrine therapy or more than 2 years after receiving adjuvant endocrine therapy; 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

You may not qualify if:

• Prior exposed to histone deacetylase inhibitors; 2.Received TKI before enrollment; 3.Exist visceral crisis; 4.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; 5.Poorly controlled diabetes (FBG\>10mmol/L); 6.Poorly controlled hypertension (SBP\>150 mmHg, DBP\>90 mmHg); 7.Urinalysis shows urine protein ≥ 2+ or 24-hour protein quantity test shows urinary protein ≥1 g; 8.PT\>16s, APTT\> 43s, TT\>21s, FIB\<2g/L; 9.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); 10.Pregnant or lactating female. 11.Any other conditions deemed inappropriate by the investigator to participate in this study.

Sponsors & Collaborators

• Jundong Wu: lead

Study Sites (1)

Affiliated Tumor Hospital of Shantou University Medical College

Shantou, China

Location

Study Officials

• caiwen du

  Cancer Hospital Chinese Academy of Medical Science, Shenzhen Center

  PRINCIPAL INVESTIGATOR

• jundong wu

  Affiliated Tumor Hospital of Shantou University Medical College

  PRINCIPAL INVESTIGATOR

Central Study Contacts

jundong wu

CONTACT

13829663428; wujun-dong@163.com

haoming wu

CONTACT

15811833918; ahand@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 INVESTIGATOR
• PI Title: Affiliated Cancer Hospital of Shantou University Medical College

Study Record Dates

• First Submitted: December 20, 2024
• First Posted: December 27, 2024
• Study Start: December 20, 2024
• Primary Completion: December 31, 2025
• Study Completion (Estimated): July 1, 2026
• Last Updated: December 27, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)