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NCT Number: NCT06750848

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

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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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Affiliated Tumor Hospital of Shantou University Medical College

Shantou, China

Location contact

jundong wu

CONTACT

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Chidamide,Fulvestrant,angiogenesis inhibitors

Drug

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

Primary outcomes

  1. Objective Response Rate(ORR)

    Time frame: 2 years

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

Secondary outcomes

  1. Progression-free survival(PFS)

    Time frame: 2 years

    Time from treatment until disease progression or death

  2. Disease Control Rate (DCR)

    Time frame: 2 years

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

  3. Clinical Benefit Rate (CBR)

    Time frame: 2 years

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

  4. Overall survival (OS)

    Time frame: 2 years

    Time from treatment until death from any cause

Study contacts

Contact information is provided by the study sponsor or research team.

haoming wu

CONTACT

[email protected]

15811833918

jundong wu

CONTACT

[email protected]

13829663428

Sponsors and collaborators

Lead sponsor

Jundong Wu

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2025
Study completion
2026
First posted
Dec 27, 2024
Registry last updated
Dec 27, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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