Advanced Breast CancerPhase 2NCT06750848
Chidamide Combined With Angiogenesis Inhibitors and Fulvestrant for Advanced HR-positive, HER2-negative Breast Cancer
A Phase 2 study testing Chidamide，Fulvestrant，angiogenesis inhibitors in people with Advanced Breast Cancer, run by Jundong Wu at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Advanced Breast Cancer
- What is being tested?
- Chidamide，Fulvestrant，angiogenesis inhibitors
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteChina
- Study dates
- 20 Dec 2024to 1 Jul 2026
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Affiliated Tumor Hospital of Shantou University Medical College
Shantou
jundong wu
About this study
Official 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
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.
- Conditions
- Advanced Breast Cancer
- Being tested
- Chidamide，Fulvestrant，angiogenesis inhibitors
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Chidamide，Fulvestrant，angiogenesis inhibitorsDrug
chidamide，30mg，po. biw fulvestrant ，500mg， im., d1(c1d15), q4w angiogenesis inhibitors , according to the doctor's advice
| Study group | Role | What they receive |
|---|---|---|
| Chidamide，Fulvestrant ，angiogenesis inhibitors | Experimental | Not described Receives: Drug: Chidamide，Fulvestrant，angiogenesis inhibitors |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective Response Rate（ORR）
Objective Response Rate（ORR）by RECIST 1.1,the total proportion of patients with complete response（CR）, partial response（PR）
Measured: 2 years
Secondary outcomes (4)
Progression-free survival(PFS)
Time from treatment until disease progression or death
Measured: 2 years
Disease Control Rate （DCR）
he total proportion of patients with complete response（CR）, partial response（PR）and stable disease（SD）
Measured: 2 years
Clinical Benefit Rate (CBR)
The total proportion of patients with Partial Response (PR), Complete Response (CR) or Stable Disease (SD) ≥6 months
Measured: 2 years
Overall survival (OS)
Time from treatment until death from any cause
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Dec 2024
- Study start20 Dec 2024 (estimated)
- Primary completion31 Dec 2025 (estimated)
- Study completion1 Jul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 48 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jundong Wu
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Jundong Wu, Affiliated Cancer Hospital of Shantou University Medical College
- Investigators
- caiwen du, Principal investigator, Cancer Hospital Chinese Academy of Medical Science, Shenzhen Centerjundong wu, Principal investigator, Affiliated Tumor Hospital of Shantou University Medical College
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06750848
- Sponsor's protocol ID
- CSIIT-C31
- Status last verified
- Dec 2024
- First submitted
- 20 Dec 2024
- Last updated
- 27 Dec 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT06750848
- Acronym / sponsor ID
- CSIIT-C31
- Conditions
- Advanced Breast Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- Jundong WuUniversity, hospital or other
- Study start
- 20 Dec 2024 (estimated)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 1 Jul 2026 (estimated)
- First posted
- 27 Dec 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Chidamide，Fulvestrant ，angiogenesis inhibitors | Experimental | Drug: Chidamide，Fulvestrant，angiogenesis inhibitors |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Chidamide，Fulvestrant，angiogenesis inhibitorschidamide，30mg，po. biw fulvestrant ，500mg， im., d1(c1d15), q4w angiogenesis inhibitors , according to the doctor's advice | Drug | Chidamide，Fulvestrant ，angiogenesis inhibitors |
Primary outcome
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）
4 secondary outcomes
Progression-free survival(PFS)
Time frame: 2 years
Disease Control Rate （DCR）
Time frame: 2 years
Clinical Benefit Rate (CBR)
Time frame: 2 years
Overall survival (OS)
Time frame: 2 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Dec 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
caiwen du principal investigator
Cancer Hospital Chinese Academy of Medical Science, Shenzhen Center
jundong wu principal investigator
Affiliated Tumor Hospital of Shantou University Medical College
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Chidamide，Fulvestrant，angiogenesis inhibitors in people with Advanced Breast Cancer, run by Jundong Wu at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 27 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact jundong wu (13829663428, wujun-dong@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective Response Rate（ORR） (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Dec 2024; AzTrials last refreshed its copy on 8 Nov 2026.