Breast CancerNCT05276713
Outcome of Tucidinostat-Based Therapy in HR+ Metastatic Breast Cancer Patients Previously Treated With CDK4/6 Inhibitor
An observational study of Breast Cancer, run by Beijing 302 Hospital at 1 site in China.
Trial summary
To evaluate the efficacy of tucidinostat-based therapy in hormone receptor-positive metastatic breast cancer patients previously treated with CDK4/6 inhibitor therapy in the real world. 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?
- Tucidinostat
- Type of treatment
- Pill or oral medicine
- How many people
- 50 participants
- Where
- 1 siteChina
- Study dates
- 10 Jul 2019to 1 Aug 2022
- Phase
- Observational
- 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
Study population: Patients diagnosed with breast cancer (according to International Classification of Diseases-10, ICD-10) with confirmed metastasis, regardless of being de novo diagnosed or progressed from a non-metastatic stage.
Who may be able to join
- 1.woman, age > 18 years old 2.Diagnosed with HR+/HER2- Metastatic Breast Cancer 3.Patients received tucidinostat-based therapy after progression on CDK4/6 inhibitor 4.Complete medical history was available
Who cannot join
- 1.Medical history was incomplete
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
The Fifth Medical Center of PLA General Hospital
Beijing, Beijing Municipality, 100071
Tao Wang, +86-010-66947172, wangtaotg@163.com
About this study
Official title: A Single-center Study of the Outcome of Tucidinostat-Based Therapy in Hormone Receptor-Positive Metastatic Breast Cancer Patients Previously Treated With CDK4/6 Inhibitor Therapy
To evaluate the efficacy of tucidinostat-based therapy in hormone receptor-positive metastatic breast cancer patients previously treated with CDK4/6 inhibitor therapy in the real world.
Read the detailed description
Cyclin-dependent kinase (CDK) 4/6 inhibitors have changed the treatment pattern of patients with hormone receptor-positive HER2-negative advanced breast cancer significantly prolongling patients'PFS and OS,but there is no optimal therapy after its progression.Tucidinostat (formerly known as chidamide) is an oral subtype-selective histone deacetylase inhibitor, ACE trial demonstrated that tucidinostat plus exemestane improved PFS compared with placebo plus exemestane in HR+,MBC patients that progressed after previous endocrine therapy,only 7 patients enrolled in the trial had previously received CDK4/6 inhibitors.The aim of this trial is to evaluate the efficacy of tucidinostat-based therapy in hormone receptor-positive metastatic breast cancer patients previously treated with CDK4/6 inhibitor therapy in the real world.
- Conditions
- Breast Cancer
- Being tested
- Tucidinostat
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TucidinostatDrug
Also called Chidamide
Tucidinostat in combination with endocrine drugs
| Study group | Role | What they receive |
|---|---|---|
| Tucidinostat-based therapy | 30 mg tucidinostat was given orally(as six 5 mg tablets per day) twice a week (either, Monday and Thursday, Tuesday and Friday, or Wednesday and Saturday) for 4 consecutive weeks in a 4-week cycle.The endocrine drugs combined with tucidinostat were given based on previous treatment.Patients received tucidinostat-based treatment until disease progression or intolerable adverse events. Receives: Drug: Tucidinostat |
What is being measured
The primary outcome is the main question the study is designed to answer.
PFS
Progression free survival
Measured: 6 weeks
Secondary outcomes (1)
Adverse events
Number of participants with treatment-related adverse events as assessed by Common Terminology Criteria for Adverse Events version 5.0 (CTCAE v5.0)
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 posted11 Mar 2022
- Study start10 Jul 2019
- Primary completion1 Jun 2022 (estimated)
- Study completion1 Aug 2022 (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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing 302 Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Tao wang, Study director, Beijing 302 Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05276713
- Sponsor's protocol ID
- Breast-Chi-2022
- Status last verified
- Mar 2022
- First submitted
- 3 Mar 2022
- Last updated
- 11 Mar 2022
- 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 11 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-center Study of the Outcome of Tucidinostat-Based Therapy in Hormone Receptor-Positive Metastatic Breast Cancer Patients Previously Treated With CDK4/6 Inhibitor Therapy
- ClinicalTrials.gov ID
- NCT05276713
- Acronym / sponsor ID
- Breast-Chi-2022
- Conditions
- Breast Cancer
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Beijing 302 HospitalUniversity, hospital or other
- Study start
- 10 Jul 2019 (actual)
- Primary completion
- 1 Jun 2022 (estimated)
- Study completion
- 1 Aug 2022 (estimated)
- First posted
- 11 Mar 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 of tucidinostat-based therapy in hormone receptor-positive metastatic breast cancer patients previously treated with CDK4/6 inhibitor therapy in the real world.
Detailed description
Cyclin-dependent kinase (CDK) 4/6 inhibitors have changed the treatment pattern of patients with hormone receptor-positive HER2-negative advanced breast cancer significantly prolongling patients'PFS and OS,but there is no optimal therapy after its progression.Tucidinostat (formerly known as chidamide) is an oral subtype-selective histone deacetylase inhibitor, ACE trial demonstrated that tucidinostat plus exemestane improved PFS compared with placebo plus exemestane in HR+,MBC patients that progressed after previous endocrine therapy,only 7 patients enrolled in the trial had previously received CDK4/6 inhibitors.The aim of this trial is to evaluate the efficacy of tucidinostat-based therapy in hormone receptor-positive metastatic breast cancer patients previously treated with CDK4/6 inhibitor therapy in the real world.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Tucidinostat-based therapy | – | Drug: Tucidinostat30 mg tucidinostat was given orally(as six 5 mg tablets per day) twice a week (either, Monday and Thursday, Tuesday and Friday, or Wednesday and Saturday) for 4 consecutive weeks in a 4-week cycle.The endocrine drugs combined with tucidinostat were given based on previous treatment.Patients received tucidinostat-based treatment until disease progression or intolerable adverse events. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients diagnosed with breast cancer (according to International Classification of Diseases-10, ICD-10) with confirmed metastasis, regardless of being de novo diagnosed or progressed from a non-metastatic stage.
Key inclusion criteria (1 listed)
- 1.woman, age > 18 years old 2.Diagnosed with HR+/HER2- Metastatic Breast Cancer 3.Patients received tucidinostat-based therapy after progression on CDK4/6 inhibitor 4.Complete medical history was available
Key exclusion criteria (1 listed)
- 1.Medical history was incomplete
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 |
|---|---|---|
| TucidinostatAlso: ChidamideTucidinostat in combination with endocrine drugs | Drug | Tucidinostat-based therapy |
Primary outcome
PFS
Time frame: 6 weeks
Progression free survival
1 secondary outcome
Adverse events
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 11 Mar 2022.
- Individual participant dataSharing planned: No
Related trials for Breast Cancer
Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions
RecruitingPhase 2
Gene Signatures to Guide HR+MBC Therapy in a Diverse Cohort
Invasive Mammary Carcinoma, Metastatic Breast Cancer
Not yet recruitingObservational study
Comparison of Reliability, Time Cost, and Participant Comfort of Lymphedema Assessments in Upper Extremity
Lymphedema, Upper Extremity Lymphedema
RecruitingPhase 3
A Study of Camrelizumab Plus Chemotherapy in Combination With or Without Famitinib as Neoadjuvant Therapy in Participants With Triple Negative Breast Cancer (BCTOP-T-N01)
TNBC - Triple-Negative Breast Cancer
RecruitingPhase 3
Testing Whether Hormone Therapy With Ribociclib is as Effective as Chemotherapy Followed by Hormone Therapy With Ribociclib for the Treatment of High Anatomic Stage Breast Cancer With Low Recurrence Risk, The RxFINE-Low Trial
Anatomic Stage II Breast Cancer AJCC v8, Anatomic Stage IIIA Breast Cancer AJCC v8
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.
Tao wang study director
Beijing 302 Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Cancer, run by Beijing 302 Hospital 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: status not confirmed, as of the sponsor's last update on 11 Mar 2022. 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.
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 Jinmei Zhou (+86-010-66947427, jinzhu2714@sina.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PFS (time frame: 6 weeks). 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 11 Mar 2022.