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

NCT ID: NCT06750848

Last Updated: 2024-12-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

PHASE2

Total Enrollment

48 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-12-20

Study Completion Date

2026-07-01

Brief Summary

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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.

Detailed Description

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Conditions

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Advanced Breast Cancer

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Chidamide，Fulvestrant ，angiogenesis inhibitors

Group Type EXPERIMENTAL

Chidamide，Fulvestrant，angiogenesis inhibitors

Intervention Type DRUG

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

Interventions

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Chidamide，Fulvestrant，angiogenesis inhibitors

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

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Jundong Wu

OTHER

Sponsor Role lead

Responsible Party

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Jundong Wu

Affiliated Cancer Hospital of Shantou University Medical College

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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caiwen du

Role: PRINCIPAL_INVESTIGATOR

Cancer Hospital Chinese Academy of Medical Science, Shenzhen Center

jundong wu

Role: PRINCIPAL_INVESTIGATOR

Affiliated Tumor Hospital of Shantou University Medical College

Locations

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Affiliated Tumor Hospital of Shantou University Medical College

Shantou, , China

Site Status

Countries

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China

Central Contacts

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jundong wu

Role: CONTACT

Phone: 13829663428

Email: [email protected]

haoming wu

Role: CONTACT

Phone: 15811833918

Email: [email protected]

Facility Contacts

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jundong wu

Role: primary

Other Identifiers

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CSIIT-C31

Identifier Type: -

Identifier Source: org_study_id