Breast CancerPhase 1/2CINDERELLANCT05464173
Chidamide in Combination With Abemaciclib and Endocrinotherapy（Doctor's Choice） in Breast Cancer Patients Previously Treated With Palbociclib
A Phase 1/2 study testing Chidamide, Abemaciclib and endocrinotherapy（doctor's choice） in people with Breast Cancer, run by Biyun Wang, MD at 1 site in China.
Trial summary
To evaluate the efficacy and safety of chidamide in combination with abemaciclib and endocrinotherapy（doctor's choice） in locally advanced/metastatic HR+/HER2- breast cancer who had failed prior palbociclib therapy Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Chidamide, Abemaciclib and endocrinotherapy（doctor's choice）
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 1 siteChina
- Study dates
- 1 Jul 2022to 1 May 2025
- Phase
- Phase 1/2
- 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
- Participants volunteered to participate in this study and signed an informed consent form.
- Female, aged ≥ 18 years.
- ECOG PS score:0-2.
- Expected survival time ≥ 3 months.
- Histologically or cytologically confirmed estrogen receptor positive and/or progesterone receptor positive, HER2-negative loco-regional recurrent or metastatic disease not amenable to resection or radiation therapy with curative intent.
- Prior anti-tumor setting: ① No prior chemotherapy for recurrent or metastatic breast cancer; ② Disease recurrence and/or metastasis during or after palbociclib-based regimen in the (neo)adjutant setting or disease progression during or after palbociclib-based regimen for at least 6 months in the metastatic setting; ③ No more than 3 lines of prior endocrine therapy for recurrent or metastatic breast cancer and meet one of the following requirements: relapse while after the first 2 years of adjuvant endocrine therapy, or disease progression after the first 6 months of latest endocrine therapy for advance or metastatic breast cancer, while on endocrine therapy;
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- At least one extracranial measurable lesion defined according to RECIST V1.1 criteria or only bone lesion;
- The functions of vital organs meet the requirements;
- Participants recovered from any AE associated with prior tumor therapy prior to initial administration of the study drug (grade ≤1);
Who cannot join
- Prior treatment with histone deacetylase inhibitors (HDACi);
- Previously treated with CDK4/6 inhibitors other than palbociclib;
- Leptomeningeal metastasis confirmed by MRI or lumbar puncture;
- Radiographically confirmed central nervous system metastasis; the following conditions were excluded: ① asymptomatic brain metastases not requiring immediate radiotherapy or surgery; ② previously received local therapy (radiotherapy or surgery) for brain metastasis, stable for at least 4 weeks with imaging confirmation without symptomatic treatment (including glucocorticoid, mannitol, bevacizumab, etc.) for more than 2 weeks and clinical symptoms;
- Participants with visceral crises (e.g., lymphangitis carcinoma, bone marrow replacement, leptomeningeal metastasis, diffuse liver metastasis with abnormal liver functions), rapid disease progression, and patients not suitable for endocrine therapy;
- Participants with ascites, pleural effusion and pericardial effusion with clinical symptoms at baseline, requiring drainage within 4 weeks before the first medication;
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- Inability to swallow, intestinal obstruction or other factors affecting drug taking and absorption;
- Systematic treatment such as chemotherapy, targeted therapy or other investigational drugs within 4 weeks prior to the start of treatment; endocrine therapy within 2 weeks prior to the start of treatment;
- Participant was diagnosed with any other malignant tumor in the past 5 years prior to the study, except for radically-treated non-melanoma skin cancer, basal cell or squamous cell skin cancer or cervical carcinoma in situ and thyroid papillary carcinoma.
- The participant has undergone major surgical procedures or significant trauma within 4 weeks prior to the start of treatment, or is expected to undergo major surgical treatment;
- Known history of allergy to the drug components of this regimen;
- Infected with active HBV and HCV; participants with stabilized hepatitis B (HBV-DNA lower than 500 IU/mL or copy number <1000 copies/ mL) and cured hepatitis C (negative for HCV RNA) were excluded;
- Have a history of immunodeficiency disease, including HIV positive, or other acquired or congenital immunodeficiency disease, or have a history of organ transplantation;
- Positive baseline pregnancy test; Or participants of reproductive age who were unwilling to use effective contraception during study participation and for at least 3 months after the last dose;
- According to the judgment of the researcher, there are serious concomitant diseases (such as severe hypertension, diabetes, thyroid disease, active infection, etc.) that endanger the patient's safety or affect the patient's completion of the study;
- The researcher determines that the participant is not suitable for the study;
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, 200032
Biyun Wang, 18017312387, pro_wangbiyun@163.com
About this study
Official title: Phase Ib/II Study of Chidamide in Combination With Abemaciclib and Endocrinotherapy（Doctor's Choice） in Patients Previously Treated With Palbociclib in HR+/HER2-Relapsed/Metastatic Breast Cancer
To evaluate the efficacy and safety of chidamide in combination with abemaciclib and endocrinotherapy（doctor's choice） in locally advanced/metastatic HR+/HER2- breast cancer who had failed prior palbociclib therapy
Read the detailed description
Phase I (Stage Ib). To evaluate the safety and tolerability of chidamide in combination with abemaciclib and endocrinotherapy（doctor's choice） in locally advanced/metastatic HR+/HER2- breast cancer and to determine the recommended phase II dose of this combination regimen.
Stage 2 (Phase II). To determine the efficacy and safety of chidamide in combination with abemaciclib and endocrinotherapy（doctor's choice） in locally advanced/metastatic HR+/HER2- breast cancer with the recommended phase II dose.
- Conditions
- Breast Cancer
- Being tested
- Chidamide, Abemaciclib, endocrinotherapy（doctor's choice）
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ChidamideDrug
10-30mg biw
AbemaciclibDrug
150mg or 100mg bid
endocrinotherapy（doctor's choice）Drug
According to the drug insert
| Study group | Role | What they receive |
|---|---|---|
| SAF | Experimental | endocrinotherapy（doctor's choice） According to the drug insert abemaciclib 150mg or 100mg bid, Chidamide 10-30mg biw. Receives: Drug: Chidamide; Drug: Abemaciclib; Drug: endocrinotherapy（doctor's choice） |
What is being measured
The primary outcome is the main question the study is designed to answer.
DLT
DLT:dose-limiting toxicity
Measured: 6 weeks
PFS
PFS：progression free survival
Measured: 6 weeks
Secondary outcomes (4)
ORR
Objective response rate (ORR) : Proportion of subjects whose efficacy was evaluated as CR/PR；
Measured: 6 weeks
DCR
Disease control rate (DCR) : Proportion of subjects whose efficacy was assessed as CR/PR/SD；
Measured: 6 weeks
CBR
Clinical benefit rate (CBR) : Proportion of subjects with CR, PR and SD≥24 weeks during the study；
Measured: 6 weeks
DOR
Duration of remission (DoR) : The time from the first assessment of CR or PR to the first assessment of PD or death from any cause；
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jul 2022
- Study start1 Jul 2022
- Primary completion1 Feb 2025 (estimated)
- Study completion1 May 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 44 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Biyun Wang, MD
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Biyun Wang, MD, Fudan University
- Investigators
- Biyun Wang, Principal investigator, Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05464173
- Sponsor's protocol ID
- YOUNGBC-19
- Acronym
- CINDERELLA
- Status last verified
- Jan 2024
- First submitted
- 15 Jun 2022
- Last updated
- 22 Jan 2024
- Results posted
- No
- Data monitoring committee
- 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 22 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase Ib/II Study of Chidamide in Combination With Abemaciclib and Endocrinotherapy（Doctor's Choice） in Patients Previously Treated With Palbociclib in HR+/HER2-Relapsed/Metastatic Breast Cancer
- ClinicalTrials.gov ID
- NCT05464173
- Acronym / sponsor ID
- CINDERELLA / YOUNGBC-19
- Conditions
- Breast Cancer
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 44 participants (estimated)
- Lead sponsor
- Biyun Wang, MDUniversity, hospital or other
- Study start
- 1 Jul 2022 (actual)
- Primary completion
- 1 Feb 2025 (estimated)
- Study completion
- 1 May 2025 (estimated)
- First posted
- 19 Jul 2022 (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.
To evaluate the efficacy and safety of chidamide in combination with abemaciclib and endocrinotherapy（doctor's choice） in locally advanced/metastatic HR+/HER2- breast cancer who had failed prior palbociclib therapy
Detailed description
Phase I (Stage Ib). To evaluate the safety and tolerability of chidamide in combination with abemaciclib and endocrinotherapy（doctor's choice） in locally advanced/metastatic HR+/HER2- breast cancer and to determine the recommended phase II dose of this combination regimen.
Stage 2 (Phase II). To determine the efficacy and safety of chidamide in combination with abemaciclib and endocrinotherapy（doctor's choice） in locally advanced/metastatic HR+/HER2- breast cancer with the recommended phase II dose.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| SAF | Experimental | Drug: Chidamide, Drug: Abemaciclib, Drug: endocrinotherapy（doctor's choice）endocrinotherapy（doctor's choice） According to the drug insert abemaciclib 150mg or 100mg bid, Chidamide 10-30mg biw. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Participants volunteered to participate in this study and signed an informed consent form.
- Female, aged ≥ 18 years.
- ECOG PS score:0-2.
- Expected survival time ≥ 3 months.
- Histologically or cytologically confirmed estrogen receptor positive and/or progesterone receptor positive, HER2-negative loco-regional recurrent or metastatic disease not amenable to resection or radiation therapy with curative intent.
Key exclusion criteria (16 listed)
- Prior treatment with histone deacetylase inhibitors (HDACi);
- Previously treated with CDK4/6 inhibitors other than palbociclib;
- Leptomeningeal metastasis confirmed by MRI or lumbar puncture;
- Radiographically confirmed central nervous system metastasis; the following conditions were excluded: ① asymptomatic brain metastases not requiring immediate radiotherapy or surgery; ② previously received local therapy (radiotherapy or surgery) for brain metastasis, stable for at least 4 weeks with imaging confirmation without symptomatic treatment (including glucocorticoid, mannitol, bevacizumab, etc.) for more than 2 weeks and clinical symptoms;
- Participants with visceral crises (e.g., lymphangitis carcinoma, bone marrow replacement, leptomeningeal metastasis, diffuse liver metastasis with abnormal liver functions), rapid disease progression, and patients not suitable for endocrine therapy;
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 |
|---|---|---|
| Chidamide10-30mg biw | Drug | SAF |
| Abemaciclib150mg or 100mg bid | Drug | SAF |
| endocrinotherapy（doctor's choice）According to the drug insert | Drug | SAF |
Primary outcome
DLT
Time frame: 6 weeks
DLT:dose-limiting toxicity
PFS
Time frame: 6 weeks
PFS：progression free survival
4 secondary outcomes
ORR
Time frame: 6 weeks
DCR
Time frame: 6 weeks
CBR
Time frame: 6 weeks
DOR
Time frame: 6 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jan 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. This study is not recruiting at the moment.
Biyun Wang principal investigator
Fudan University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Chidamide, Abemaciclib and endocrinotherapy（doctor's choice） in people with Breast Cancer, run by Biyun Wang, MD 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 9 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 22 Jan 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 combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
Contact Biyun Wang (18017312387, wangbiyun0107@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
DLT (time frame: 6 weeks). The study lists 2 primary outcomes in all. 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 22 Jan 2024.