Hormone Receptor-positive Advanced Breast CancerPhase 2NCT05806047
Combination of Chidamide and Fulvestrant for HR+/HER2- Breast Cancer That Has Failed Previous CDK4/6 i Adjuvant Therapy
A Phase 2 study testing chidamide combined with fulvestrant in people with Hormone Receptor-positive Advanced Breast Cancer, run by Fudan University.
Trial summary
This trial is a single-arm study. The purpose of the trial is to evaluate the efficacy and safety of chidamide and fulvestrant in HR+/HER2- breast cancer that has failed prior adjuvant endocrine therapy with CDK4/6 inhibitors. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Hormone Receptor-positive Advanced Breast Cancer
- What is being tested?
- chidamide combined with fulvestrant
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 23 participants
- Where
- No sites listed yet
- Study dates
- 1 May 2023to 1 Nov 2024
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Female, ≥18 years old;
- ECOG score 0-1;
- Predicted survival ≥3 months;
- Patients with locally advanced and/or metastatic breast cancer confirmed by histopathology with positive ER expression and negative ER2 expression;
- Patients who have relapsed or metastasized during or after CDK4/6 inhibitors combined with endocrine adjuvant therapy and have not received systemic antitumor therapy for the current stage of disease;
- No previous treatment with fluvestran or use of fluvestran without proven treatment failure;
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- The time interval between non-endocrine therapy should be ≥2 weeks;
- At least one extracranial measurable lesion as defined by RECIST V1.1 criteria;
- The functions of vital organs meet the requirements;
- Fertile subjects must have a negative pregnancy test 7 days before starting treatment and must use an appropriate contraceptive method during treatment and for three months after completion of treatment;
- The patient is fully informed and voluntarily signs the informed consent.
Who cannot join
- Prior treatment with any HDAC inhibitors;
- Known allergy to the tested drug component;
- inflammatory breast cancer at the time of screening;
- pia meningeal metastasis confirmed by MRI or lumbar puncture;
- Central nervous system metastasis confirmed by imaging;
- To the best of the investigator's judgment, symptomatic visceral disease or any disease load or none is considered optimal Endocrine therapy options are not suitable for endocrine therapy;
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- Inability or unwillingness to swallow medication or receive intramuscular injections;
- Gastrointestinal insufficiency or gastrointestinal disease (if not controlled) that may significantly affect study drug absorption Ulcerative disease, uncontrolled nausea, vomiting, diarrhea, malabsorption syndrome or small intestine resection, etc.;
- Patients with ascites, pleural effusion and pericardial effusion accompanied by clinical symptoms in the baseline period need drainage, or use it for the first time Patients with serous cavity drainage within 4 weeks before medication;
- A history of immunodeficiency, including HIV positive, or other acquired or congenital immunodeficiency conditions, Or have a history of organ transplantation;
- Other malignancies (cured basal cell carcinoma of the skin, carcinoma in situ of the cervix, and Thyroid cancer is excluded);
- had undergone major surgical procedures or significant trauma within 4 weeks prior to the start of treatment, or was expected to undergo major surgery Surgical treatment;
- Concomitant diseases that, in the investigator's judgment, seriously endanger patient safety or interfere with patient completion of the study (e.g.
- Severe hypertension, diabetes, thyroid disease, co-active hepatitis B/C, and other activities Sexual infection);
- Inability to understand or follow research instructions and requirements;
- The researcher decides that it is not suitable to participate in this study
About this study
Official title: Phase II Clinical Study of Combination of Chidamide and Fulvestrant for HR+/HER2- Breast Cancer That Has Failed Prior Adjuvant Therapy With CDK4/6 Inhibitors
This trial is a single-arm study. The purpose of the trial is to evaluate the efficacy and safety of chidamide and fulvestrant in HR+/HER2- breast cancer that has failed prior adjuvant endocrine therapy with CDK4/6 inhibitors.
Read the detailed description
The study was a single-center, single-arm, open trial design. Twenty-three patients with advanced HR+/HER2- breast cancer who had failed previous adjuvant treatment with CDK4/6 inhibitors in combination with endocrine therapy were treated with fulvestrant and chidamide.
- Being tested
- chidamide combined with fulvestrant
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
chidamide combined with fulvestrantDrug
chidamide combined with fulvestrant
| Study group | Role | What they receive |
|---|---|---|
| chidamide combined with fulvestrant | Experimental | chidamide combined with fulvestrant Receives: Drug: chidamide combined with fulvestrant |
What is being measured
The primary outcome is the main question the study is designed to answer.
ORR
The proportion of participants whose best outcome is complete remission or partial remission (according to RECIST1.1)
Measured: max 6 months
Secondary outcomes (3)
PFS
time to progressive disease (according to RECIST1.1)
Measured: Randomization until the first occurrence of disease progression or death from any cause, which ever occurs first, through the end of study (approximately 1 years)
CBR
The percentage of subjects with CR+PR+SD and last more than 24 weeks in all of the participants.
Measured: max 6 months
DOR
Duration of Overall Response.The date of the first assessed PR/CR (according to RECIST 1.1) to the date of the first assessed tumor progression (according to RECIST 1.1) or death from any cause.
Measured: max 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Apr 2023
- Study start1 May 2023 (estimated)
- Primary completion1 May 2024 (estimated)
- Study completion1 Nov 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hormone Receptor-positive Advanced Breast CancerStudies of the same condition, open and under way.
- More trials run by Fudan UniversityThe sponsor's other registered studies.
- 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
- Model description
- chidamide combined with fulvestrant
- Masking
- None (open label)
- Enrolment
- 23 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fudan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zhimin Shao, Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05806047
- Sponsor's protocol ID
- CSIIT-C41
- Status last verified
- Mar 2023
- First submitted
- 14 Mar 2023
- Last updated
- 10 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Clinical Study of Combination of Chidamide and Fulvestrant for HR+/HER2- Breast Cancer That Has Failed Prior Adjuvant Therapy With CDK4/6 Inhibitors
- ClinicalTrials.gov ID
- NCT05806047
- Acronym / sponsor ID
- CSIIT-C41
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 23 participants (estimated)
- Lead sponsor
- Fudan UniversityUniversity, hospital or other
- Study start
- 1 May 2023 (estimated)
- Primary completion
- 1 May 2024 (estimated)
- Study completion
- 1 Nov 2024 (estimated)
- First posted
- 10 Apr 2023 (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 trial is a single-arm study. The purpose of the trial is to evaluate the efficacy and safety of chidamide and fulvestrant in HR+/HER2- breast cancer that has failed prior adjuvant endocrine therapy with CDK4/6 inhibitors.
Detailed description
The study was a single-center, single-arm, open trial design. Twenty-three patients with advanced HR+/HER2- breast cancer who had failed previous adjuvant treatment with CDK4/6 inhibitors in combination with endocrine therapy were treated with fulvestrant and chidamide.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- chidamide combined with fulvestrant
| Arm | Type | Receives |
|---|---|---|
| chidamide combined with fulvestrant | Experimental | Drug: chidamide combined with fulvestrantchidamide combined with fulvestrant |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Female, ≥18 years old;
- ECOG score 0-1;
- Predicted survival ≥3 months;
- Patients with locally advanced and/or metastatic breast cancer confirmed by histopathology with positive ER expression and negative ER2 expression;
- Patients who have relapsed or metastasized during or after CDK4/6 inhibitors combined with endocrine adjuvant therapy and have not received systemic antitumor therapy for the current stage of disease;
Key exclusion criteria (16 listed)
- Prior treatment with any HDAC inhibitors;
- Known allergy to the tested drug component;
- inflammatory breast cancer at the time of screening;
- pia meningeal metastasis confirmed by MRI or lumbar puncture;
- Central nervous system metastasis confirmed by imaging;
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 combined with fulvestrantchidamide combined with fulvestrant | Drug | chidamide combined with fulvestrant |
Primary outcome
ORR
Time frame: max 6 months
The proportion of participants whose best outcome is complete remission or partial remission (according to RECIST1.1)
3 secondary outcomes
PFS
Time frame: Randomization until the first occurrence of disease progression or death from any cause, which ever occurs first, through the end of study (approximately 1 years)
CBR
Time frame: max 6 months
DOR
Time frame: max 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Apr 2023.
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing chidamide combined with fulvestrant in people with Hormone Receptor-positive Advanced Breast Cancer, run by Fudan University.
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 11 inclusion and 16 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: status not confirmed, as of the sponsor's last update on 10 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ORR (time frame: max 6 months). 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 10 Apr 2023.