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Not yet recruitingNCT06750848Updated Dec 27, 2024

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

A Phase 2 interventional study of Chidamide,Fulvestrant,angiogenesis inhibitors in Advanced Breast Cancer, sponsored by Jundong Wu. Not yet recruiting at 1 site in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2024-12-27.

Sponsored by Jundong Wu · Phase 2, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by Dec 2025, 9 months ago, but the record still lists the study as not yet recruiting.
Phase
Phase 2
Study type
Interventional
Enrollment
48
Allocation
Not applicable
Ages
18 Years to 75 Years
Sex
All
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Study 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.

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Conditions studied

  • Advanced Breast Cancer

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03

In context

Breast Neoplasms

12,543 studies on the registry are indexed under Breast Neoplasms; 2,892 are open to participants now.

This study's planned enrollment of 48 is below the median of 72 across 9,302 interventional studies indexed under Breast Neoplasms.

Browse Breast Neoplasms studies →

Lead sponsor

This is the only study on the registry with Jundong Wu as lead sponsor.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
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Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
48 participants (estimated)

Study arms

  • Experimental
    Chidamide,Fulvestrant ,angiogenesis inhibitors

    Drug: Chidamide,Fulvestrant,angiogenesis inhibitors

Interventions

  • DrugChidamide,Fulvestrant,angiogenesis inhibitors

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

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What researchers measure

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)

    Time frame: 2 years

Secondary outcomes

  1. Progression-free survival(PFS)

    Time from treatment until disease progression or death

    Time frame: 2 years

  2. Disease Control Rate (DCR)

    he total proportion of patients with complete response(CR), partial response(PR)and stable disease(SD)

    Time frame: 2 years

  3. Clinical Benefit Rate (CBR)

    The total proportion of patients with Partial Response (PR), Complete Response (CR) or Stable Disease (SD) ≥6 months

    Time frame: 2 years

  4. Overall survival (OS)

    Time from treatment until death from any cause

    Time frame: 2 years

07

Study locations

1 site
  • Affiliated Tumor Hospital of Shantou University Medical College
    Shantou, China
    • jundong wu · Contact
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 27, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06750848
Lead sponsor
Jundong Wu
Responsible party
Jundong Wu (Affiliated Cancer Hospital of Shantou University Medical College, Affiliated Cancer Hospital of Shantou University Medical College) — Sponsor-investigator
First posted
Dec 27, 2024
Start date
Dec 20, 2024 (estimated)
Primary completion
Dec 31, 2025 (estimated)
Completion
Jul 1, 2026 (estimated)
Last update
Dec 27, 2024

Study contacts

jundong wu
Contact
wujun-dong@163.com
13829663428
haoming wu
Contact
ahand@126.com
15811833918
caiwen du
principal investigator · Cancer Hospital Chinese Academy of Medical Sciences, Shenzhen Center
jundong wu
principal investigator · Affiliated Tumor Hospital of Shantou University Medical College

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Dec 2024. You cannot join it, but the record below documents what was studied.

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