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

Chidamide Combined With Angiogenesis Inhibitors and Fulvestrant for Advanced HR-positive, HER2-negative Breast Cancer After Prior CDK4/6 Inhibitor Progression : a Single Arm, Phase Ⅱ Study

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Advanced Breast Cancer
• Intervention / Treatment: Drug: Chidamide，Fulvestrant，angiogenesis inhibitors

• Study Type: Interventional
• Enrollment (Estimated): 48
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: jundong wu; Phone Number: 13829663428; Email: wujun-dong@163.com
• Study Contact Backup: Name: haoming wu; Phone Number: 15811833918; Email: ahand@126.com

Study Locations

• China
  • Shantou, China
    • Affiliated Tumor Hospital of Shantou University Medical College
    • Contact: jundong wu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

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 ≥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

Exclusion Criteria:

• 1.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.

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Progression-free survival(PFS)	Time from treatment until disease progression or death	2 years
Overall survival (OS)	Time from treatment until death from any cause	2 years
Disease Control Rate （DCR）	he total proportion of patients with complete response（CR）, partial response（PR）and stable disease（SD）	2 years
Clinical Benefit Rate (CBR)	The total proportion of patients with Partial Response (PR), Complete Response (CR) or Stable Disease (SD) ≥6 months	2 years

Collaborators and Investigators

• Sponsor: Jundong Wu
• Investigators: Principal Investigator: caiwen du, Cancer Hospital Chinese Academy of Medical Sciences, ShenZhen center; Principal Investigator: jundong wu, Affiliated Tumor Hospital of Shantou University Medical College

Study record dates

Study Major Dates

• Study Start (Estimated): December 20, 2024
• Primary Completion (Estimated): December 31, 2025
• Study Completion (Estimated): July 1, 2026

Study Registration Dates

• First Submitted: December 20, 2024
• First Submitted That Met QC Criteria: December 20, 2024
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: December 20, 2024
• Last Verified: December 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Skin Diseases; Breast Diseases; Breast Neoplasms; Antineoplastic Agents; Physiological Effects of Drugs; Hormones, Hormone Substitutes, and Hormone Antagonists; Antineoplastic Agents, Hormonal; Hormone Antagonists; Angiogenesis Modulating Agents; Growth Substances; Growth Inhibitors; Estrogen Receptor Antagonists; Estrogen Antagonists; Fulvestrant; Angiogenesis Inhibitors
• Other Study ID Numbers: CSIIT-C31

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