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Tucidinostat and Metronomic Capecitabine for Metastatic Triple-negative Breast Cancer:a Multicenter,Open-label, Randomized Controlled, Phase II Clinical Trial

Primary Purpose

Triple Negative Breast Cancer

Status
Recruiting
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Capecitabine
Tucidinostat
Sponsored by
wang shusen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Triple Negative Breast Cancer focused on measuring Triple Negative Breast Cancer, Tucidinostat, Capecitabine, Metronomic therapy

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

1. ≥18 years old, female; 2. Histologically confirmed triple-negative metastatic breast cancer [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, subjects with ER ≤ 10% and PR ≤ 10% and those with no benefit from endocrine therapy in the investigator's judgment are allowed to enroll]; 3. Metastatic breast cancer that has failed at first-line taxane therapy; definition of taxane treatment failure: disease progression during rescue therapy, or recurrence and metastasis within 12 months after completion of adjuvant therapy; 4. ECOG score 0-1; 5. According to RECIST1.1 criteria, at least there is one measurable lesion; 6. The main organ and bone marrow function levels meet the following requirements:

  1. 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.
  2. 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);
  3. Renal function: serum creatinine (Cr)≤1.5×ULN or creatinine clearance rate>60mL/min; 7. Expected survival time ≥ 3 months; 8. Voluntary participation study, signed written informed consent.

Exclusion Criteria:

  1. Known hypersensitivity to capecitabine or tucidinostat; patients with previous severe, unexpected reactions to fluoropyrimidines or known hypersensitivity to fluoropyrimidines;
  2. Patients with complete deficiency of dihydropyrimidine dehydrogenase (DPD) activity;
  3. Received palliative radiotherapy for target lesion within 4 weeks before enrollment;
  4. Previously received treatment with histone deacetylase inhibitors,or have previously received fluoropicidine drugs such as capecitabine and stopped drugs due to progress (if it is used in the adjuvant phase, then the progress of the treatment within 1 year after the suspension of the drug was stopped, and the group cannot be admitted to the study).
  5. Patients with gastrointestinal perforation, fistula, abdominal abscess, gastrointestinal ulcer or active diverticulosis before enrollment;
  6. 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;
  7. 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);
  8. Patients with currently symptomatic brain or meningeal metastasis;
  9. 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;
  10. 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);
  11. Patients with active pulmonary tuberculosis who are receiving anti-tuberculosis treatment or have received anti-tuberculosis treatment within 1 year before screening;
  12. Complications requiring long-term use of immunosuppressive drugs, or systemic or topical use of corticosteroids with immunosuppressive doses;
  13. Received any anti-infection vaccine (such as influenza vaccine, chickenpox vaccine, etc.) within 4 weeks before enrollment;
  14. 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;
  15. 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;
  16. 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);
  17. 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.;
  18. Inability to swallow, bowel obstruction, or other factors that interfere with drug taking and absorption;
  19. A history of immunodeficiency, including HIV test positive, or other acquired or congenital immunodeficiency diseases, or a history of organ transplantation;
  20. 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;
  21. Serious concomitant disease or other comorbidities that would interfere with planned treatment;
  22. Any other conditions deemed inappropriate by the investigator to participate in this study.

Sites / Locations

  • Sun-yat sen university cancer centerRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Tucidinostat and metronomic capecitabine group

metronomic capecitabine group

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Progress-free survival
Time from randomization to the first documentation of objective tumor progression or to death due to any cause
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.
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.

Full Information

First Posted
May 21, 2022
Last Updated
November 1, 2022
Sponsor
wang shusen
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1. Study Identification

Unique Protocol Identification Number
NCT05390476
Brief Title
Tucidinostat and Metronomic Capecitabine for Metastatic Triple-negative Breast Cancer:a Multicenter,Open-label, Randomized Controlled, Phase II Clinical Trial
Official Title
Tucidinostat and Metronomic Capecitabine for Metastatic Triple-negative Breast Cancer:a Multicenter,Open-label, Randomized Controlled, Phase II Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Recruiting
Study Start Date
August 1, 2022 (Actual)
Primary Completion Date
February 1, 2024 (Anticipated)
Study Completion Date
December 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
wang shusen

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
The objective of this study is to explore and evaluate the efficacy of tucidinostat combined with metronomic capecitabine in the treatment of metastatic triple-negative breast cancer.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Triple Negative Breast Cancer
Keywords
Triple Negative Breast Cancer, Tucidinostat, Capecitabine, Metronomic therapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
126 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Tucidinostat and metronomic capecitabine group
Arm Type
Experimental
Arm Title
metronomic capecitabine group
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
Capecitabine
Other Intervention Name(s)
xeloda
Intervention Description
500mg orally three times a day (continuously)
Intervention Type
Drug
Intervention Name(s)
Tucidinostat
Other Intervention Name(s)
Chidamide
Intervention Description
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)
Primary Outcome Measure Information:
Title
Objective Response Rate
Description
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
Time Frame
Up to 3 years
Secondary Outcome Measure Information:
Title
Progress-free survival
Description
Time from randomization to the first documentation of objective tumor progression or to death due to any cause
Time Frame
Up to 3 years
Title
Disease Control Rate
Description
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.
Time Frame
Up to 3 years
Title
Overall Survival
Description
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.
Time Frame
Up to 3 years

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 1. ≥18 years old, female; 2. Histologically confirmed triple-negative metastatic breast cancer [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, subjects with ER ≤ 10% and PR ≤ 10% and those with no benefit from endocrine therapy in the investigator's judgment are allowed to enroll]; 3. Metastatic breast cancer that has failed at first-line taxane therapy; definition of taxane treatment failure: disease progression during rescue therapy, or recurrence and metastasis within 12 months after completion of adjuvant therapy; 4. ECOG score 0-1; 5. According to RECIST1.1 criteria, at least there is one measurable lesion; 6. 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; 7. Expected survival time ≥ 3 months; 8. Voluntary participation study, signed written informed consent. Exclusion Criteria: Known hypersensitivity to capecitabine or tucidinostat; patients with previous severe, unexpected reactions to fluoropyrimidines or known hypersensitivity to fluoropyrimidines; Patients with complete deficiency of dihydropyrimidine dehydrogenase (DPD) activity; Received palliative radiotherapy for target lesion within 4 weeks before enrollment; Previously received treatment with histone deacetylase inhibitors,or have previously received fluoropicidine drugs such as capecitabine and stopped drugs due to progress (if it is used in the adjuvant phase, then the progress of the treatment within 1 year after the suspension of the drug was stopped, and the group cannot be admitted to the study). 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Susen Wang, MD
Phone
+86-13926168469
Email
wangshs@sysucc.org.cn
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Susen Wang, MD
Organizational Affiliation
Sun Yat-sen University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Sun-yat sen university cancer center
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510060
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Shusen Wang, MD
Phone
+86-13926168469
Email
wangshs@sysucc.org.cn

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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Tucidinostat and Metronomic Capecitabine for Metastatic Triple-negative Breast Cancer:a Multicenter,Open-label, Randomized Controlled, Phase II Clinical Trial

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