Breast CancerPhase 2NCT05411380
Tucidinostat Combined With Metronomic Capecitabine and Endocrine Therapy for Advanced HR-positive, HER2-negative Breast Cancer After CDK4/6 Inhibitor.
A Phase 2 study testing Tucidinostat, Capecitabine and Endocrine Therapy in people with Breast Cancer, run by wang shusen at 1 site in China.
Trial summary
The study is designed to explore the clinical benefit following treatment with tucidinosta in combination with metronomic capecitabine and endocrine therapy in patients with hormone receptor-positive, Her2-negative advanced breast cancer who have received CDK4/6 Inhibitor treatment. Read more about this study
- Who is it for?
- Ages 18 to 75 years, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Tucidinostat, Capecitabine and Endocrine Therapy
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 73 participants
- Where
- 1 siteChina
- Study dates
- 3 Oct 2022to 1 Apr 2025
- 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 to 75 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 1. ≥18 years old, and ≤75 years old, 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 ≥1%;]; 3. After the failure of previous CDK4/6 inhibitor therapy; 4.Receive one line of chemotherapy at most; 5.Premenopausal women need to take effective measures to suppress ovarian function, such as drug suppression, oophorectomy; 6.ECOG score 0-1; 7. According to RECIST1.1 criteria, at least there is one measurable lesion or simple bone metastasis; 8. The main organ and bone marrow function levels meet the following requirements:
- Blood routine: neutrophil (ANC) ≥ 1.5×109/L; platelet count (PLT) ≥ 90× 109/L; hemoglobin (Hb) ≥ 90g/L; It is required that no blood products (including red blood cells and platelet products, etc.) have been transfused and no growth factors (including colony-stimulating factor, interleukin, and erythropoietin, etc.) have been used for supportive treatment within 2 weeks before the examination.
- Liver function: serum total bilirubin (TBIL) ≤ 1.5 × upper limit of normal (ULN); alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.5 × ULN (with liver Requirements for metastatic patients: ALT and AST≤5×ULN);
- Renal function: serum creatinine (Cr)≤1.5×ULN or creatinine clearance rate>60mL/min;
- 9. Expected survival time ≥ 3 months; 10. Voluntary participation study, signed written informed consent.
Who cannot join
- Known hypersensitivity to any formulation component of the study drug;
- patients with previous severe, unexpected reactions to fluoropyrimidines or known hypersensitivity to fluoropyrimidines;
- Patients with complete deficiency of dihydropyrimidine dehydrogenase (DPD) activity;
- Visceral crisis;
- Previously received treatment with histone deacetylase inhibitors or fluoropyrimidine drugs such as capecitabine;
- 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;
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- Received palliative radiotherapy for local lesions within 4 weeks before enrollment;
- Patients with gastrointestinal perforation, fistula, abdominal abscess, gastrointestinal ulcer or active diverticulosis before enrollment;
- Significant malnutrition (weight loss > 5% in the past 1 month or > 15% in the past 3 months, or food intake decreased by 1/2 or more in the past week), or still need to rely on intravenous nutritional support during the screening period;
- 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);
- Patients with currently symptomatic brain or meningeal metastasis;
- Received immunosuppressive drugs within 4 weeks before enrollment, excluding nasal spray, inhalation or other local glucocorticoids or physiological doses systemic glucocorticoids (no more than 10 mg/day of prednisone or other glucocorticoids at an equivalent dose), or use of glucocorticoids for the prevention of contrast medium allergy;
- The patient has any active autoimmune disease or has history of immune disorders (including but not limited to: interstitial pneumonia, uveitis, enteritis, hepatitis, hypophysitis, nephritis, hyperthyroidism, hypothyroidism; patients with vitiligo or complete remission of asthma in childhood without any intervention in adulthood can be included; those with asthma that require medical intervention with bronchodilators are not included);
- Patients with active pulmonary tuberculosis who are receiving anti-tuberculosis treatment or have received anti-tuberculosis treatment within 1 year before screening;
- Complications requiring long-term use of immunosuppressive drugs, or systemic or topical use of corticosteroids with immunosuppressive doses;
- Received any anti-infection vaccine (such as influenza vaccine, chickenpox vaccine, etc.) within 4 weeks before enrollment;
- Received major surgery (craniotomy, thoracotomy or laparotomy) within 4 weeks before enrollment or is expected to undergo major surgery during the study treatment period; received exploratory laparoscopic surgery within 2 weeks prior to enrollment;received central venous catheterization within 7 days prior to enrollment;
- Concurrent participation in another interventional clinical study, unless participating in an observational (non-interventional) clinical study or in the safety follow-up of an interventional study Stage;
- Known acute or chronic active hepatitis B (HBsAg positive and HBV DNA virus Load ≥ULN or ≥10^3 copies/mL) or acute or chronic active hepatitis C (HCV antibody positive and HCV RNA positive);
- Severe heart disease or discomfort, including but not limited to the following diseases: 1) Diagnosed history of heart failure or systolic dysfunction (LVEF<50%); 2) arrhythmias requiring medical treatment or clinically significant; 3) high-risk uncontrolled arrhythmias, such as atrial tachycardia, resting heart rate > 100 bpm, significant ventricular arrhythmia (such as ventricular tachycardia) or higher-grade AV block (ie Mobitz II second-degree AV block or third-degree AV block); 4) Angina pectoris; 5 ) Clinically significant valvular heart disease; 6) ECG shows transmural myocardial infarction; 7) Any other heart disease judged by the investigator to be inappropriate to participate in this trial, etc.;
- Inability to swallow, bowel obstruction, or other factors that interfere with drug taking and absorption;
- A history of immunodeficiency, including HIV test positive, or other acquired or congenital immunodeficiency diseases, or a history of organ transplantation;
- Pregnant, lactating female patients, female patients of childbearing potential with a positive baseline pregnancy test, or patients of childbearing age who are unwilling to use effective contraception throughout the trial and within 6 months after the last study drug;
- Serious concomitant disease or other comorbidities that would interfere with planned treatment;
- Any other conditions deemed inappropriate by the investigator to participate in this study.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Shusen Wang
Guangzhou, Gangdong
shusen wang, MD, +8613926168469, wangshs@sysucc.org.cn
About this study
Official title: Tucidinostat Combined With Metronomic Capecitabine and Endocrine Therapy for Advanced HR-positive, HER2-negative Breast Cancer After CDK4/6 Inhibitor：a Prospective, Single-arm, Phase II Clinical Trial.
The study is designed to explore the clinical benefit following treatment with tucidinosta in combination with metronomic capecitabine and endocrine therapy in patients with hormone receptor-positive, Her2-negative advanced breast cancer who have received CDK4/6 Inhibitor treatment.
- Conditions
- Breast Cancer
- Being tested
- Tucidinostat, Capecitabine, Endocrine Therapy
- Keywords
- metronomic capecitabine, endocrine therapy, histone deacetylase inhibitor, metastatic breast cancer
- 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
20mg each time, orally 30 minutes after dinner, 3 weeks for a cycle, administered on day 1, day 4, day 8, day 11, day 15,and day 18 of each cycle (twice a week, at least 3 days between each administration)
CapecitabineDrug
Also called Xeloda
500mg orally three times a day (continuously)
Endocrine TherapyDrug
Also called Anastrozole, Letrozole, Exemestane, Fulvestrant
Anastrozole, 1mg, orally once daily or Letrozole, 2.5mg, orally once daily or Exemestane , 25mg, orally once daily or fulvestrant 500 mg each time, intramuscularly, injected on the 1st day and 15th day of the 1st cycle, and on the 1st day for subsequent cycle( 4 weeks for one cycle)
| Study group | Role | What they receive |
|---|---|---|
| Tucidinostat+Metronomic Capecitabine+Endocrine Therapy | Experimental | This arm is divided into two groups. The main difference of this two groups lies in the selection of endocrine therapy. One is supposed to choose aromatase inhibitor, and the other is fulvestrant. The principle of making choice is based on the history of endocrine drug use. Receives: Drug: Tucidinostat; Drug: Capecitabine; Drug: Endocrine Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective Response Rate
Objective response is defined as a complete response (CR) or partial response (PR) according to RECIST v.1.1 recorded from randomization until disease progression or death due to any cause
Measured: Up to 3 years
Secondary outcomes (3)
Progress-free survival
Time from randomization to the first documentation of objective tumor progression or to death due to any cause.
Measured: Up to 3 years
Disease Control Rate
Disease control is defined as complete response (CR), partial response (PR), or stable disease (SD) ≥24 weeks according to the RECIST version 1.1 recorded in the time period between randomization and disease progression or death to any cause.
Measured: Up to 3 years
Overall Survival
Time from randomization to date of death due to any cause. according to the RECIST version 1.1 recorded in the time period between randomization and disease progression or death to any cause.
Measured: Up to 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2022
- Study start3 Oct 2022
- Primary completion1 Apr 2024 (estimated)
- Study completion1 Apr 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 73 participants (estimated)
Sponsor and investigators
- Lead sponsor
- wang shusen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, wang shusen, Sun Yat-sen University
- Investigators
- Susen Wang, MD, Principal investigator, Sun Yat-sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05411380
- Sponsor's protocol ID
- SYSUCC-020
- Status last verified
- Nov 2022
- First submitted
- 5 Jun 2022
- Last updated
- 4 Nov 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tucidinostat Combined With Metronomic Capecitabine and Endocrine Therapy for Advanced HR-positive, HER2-negative Breast Cancer After CDK4/6 Inhibitor：a Prospective, Single-arm, Phase II Clinical Trial.
- ClinicalTrials.gov ID
- NCT05411380
- Acronym / sponsor ID
- SYSUCC-020
- Conditions
- Breast Cancer
- Keywords
- metronomic capecitabine, endocrine therapy, histone deacetylase inhibitor, metastatic breast cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 73 participants (estimated)
- Lead sponsor
- wang shusenUniversity, hospital or other
- Study start
- 3 Oct 2022 (actual)
- Primary completion
- 1 Apr 2024 (estimated)
- Study completion
- 1 Apr 2025 (estimated)
- First posted
- 9 Jun 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.
The study is designed to explore the clinical benefit following treatment with tucidinosta in combination with metronomic capecitabine and endocrine therapy in patients with hormone receptor-positive, Her2-negative advanced breast cancer who have received CDK4/6 Inhibitor treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Tucidinostat+Metronomic Capecitabine+Endocrine Therapy | Experimental | Drug: Tucidinostat, Drug: Capecitabine, Drug: Endocrine TherapyThis arm is divided into two groups. The main difference of this two groups lies in the selection of endocrine therapy. One is supposed to choose aromatase inhibitor, and the other is fulvestrant. The principle of making choice is based on the history of endocrine drug use. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 1. ≥18 years old, and ≤75 years old, 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 ≥1%;]; 3. After the failure of previous CDK4/6 inhibitor therapy; 4.Receive one line of chemotherapy at most; 5.Premenopausal women need to take effective measures to suppress ovarian function, such as drug suppression, oophorectomy; 6.ECOG score 0-1; 7. According to RECIST1.1 criteria, at least there is one measurable lesion or simple bone metastasis; 8. The main organ and bone marrow function levels meet the following requirements:
- Blood routine: neutrophil (ANC) ≥ 1.5×109/L; platelet count (PLT) ≥ 90× 109/L; hemoglobin (Hb) ≥ 90g/L; It is required that no blood products (including red blood cells and platelet products, etc.) have been transfused and no growth factors (including colony-stimulating factor, interleukin, and erythropoietin, etc.) have been used for supportive treatment within 2 weeks before the examination.
- Liver function: serum total bilirubin (TBIL) ≤ 1.5 × upper limit of normal (ULN); alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.5 × ULN (with liver Requirements for metastatic patients: ALT and AST≤5×ULN);
- Renal function: serum creatinine (Cr)≤1.5×ULN or creatinine clearance rate>60mL/min;
- 9. Expected survival time ≥ 3 months; 10. Voluntary participation study, signed written informed consent.
Key exclusion criteria (25 listed)
- Known hypersensitivity to any formulation component of the study drug;
- patients with previous severe, unexpected reactions to fluoropyrimidines or known hypersensitivity to fluoropyrimidines;
- Patients with complete deficiency of dihydropyrimidine dehydrogenase (DPD) activity;
- Visceral crisis;
- Previously received treatment with histone deacetylase inhibitors or fluoropyrimidine drugs such as capecitabine;
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: Chidamide20mg each time, orally 30 minutes after dinner, 3 weeks for a cycle, administered on day 1, day 4, day 8, day 11, day 15,and day 18 of each cycle (twice a week, at least 3 days between each administration) | Drug | Tucidinostat+Metronomic Capecitabine+Endocrine Therapy |
| CapecitabineAlso: Xeloda500mg orally three times a day (continuously) | Drug | Tucidinostat+Metronomic Capecitabine+Endocrine Therapy |
| Endocrine TherapyAlso: Anastrozole, Letrozole, Exemestane, FulvestrantAnastrozole, 1mg, orally once daily or Letrozole, 2.5mg, orally once daily or Exemestane , 25mg, orally once daily or fulvestrant 500 mg each time, intramuscularly, injected on the 1st day and 15th day of the 1st cycle, and on the 1st day for subsequent cycle( 4 weeks for one cycle) | Drug | Tucidinostat+Metronomic Capecitabine+Endocrine Therapy |
Primary outcome
Objective Response Rate
Time frame: Up to 3 years
Objective response is defined as a complete response (CR) or partial response (PR) according to RECIST v.1.1 recorded from randomization until disease progression or death due to any cause
3 secondary outcomes
Progress-free survival
Time frame: Up to 3 years
Disease Control Rate
Time frame: Up to 3 years
Overall Survival
Time frame: Up to 3 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2022.
- Individual participant dataSharing planned: Undecided
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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.
Susen Wang, MD principal investigator
Sun Yat-sen University
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 Tucidinostat, Capecitabine and Endocrine Therapy in people with Breast Cancer, run by wang shusen 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 5 inclusion and 25 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 4 Nov 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.
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?
Contact Susen Wang, MD (+86-13926168469, wangshs@sysucc.org.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective Response Rate (time frame: Up to 3 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 4 Nov 2022.