NCT06750848Not yet recruitingPhase 2
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
Source: ClinicalTrials.gov · Last updated 27 Dec 2024 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 48 (estimated)
- First submitted
- 20 Dec 2024
- Start date
- 20 Dec 2024
- Primary completion date
- 31 Dec 2025
- Lead sponsor
- Jundong Wu
- Diseases
- Metastatic breast cancer
- NCT number
- NCT06750848
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 48
- From 20 Dec 2024 to the primary completion date, 31 Dec 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Lab values
- 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.
Who the study is looking for
- 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
Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Affiliated Tumor Hospital of Shantou University Medical College Coordinator of this site? Confirm its status | Shantou | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.