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Triple Negative Breast CancerPhase 2NCT05390476

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

A Phase 2 study testing Capecitabine and Tucidinostat in people with Triple Negative Breast Cancer, run by wang shusen at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 75 years, women only
Conditions the study is for
Triple Negative Breast Cancer
What is being tested?
Capecitabine and Tucidinostat
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
126 participants
Where
1 siteChina
Study dates
1 Aug 2022to 1 Dec 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 to 75 years
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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;
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  • 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.

Susen Wang, MD contact

+86-13926168469

wangshs@sysucc.org.cn

China1 site, 1 recruiting

  • Sun-yat sen university cancer center

    Guangzhou, Guangdong, 510060

    Shusen Wang, MD, +86-13926168469, wangshs@sysucc.org.cn

    Recruiting

Other trials in China

About this study

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.

Being tested
Capecitabine, Tucidinostat
Keywords
Triple Negative Breast Cancer, Tucidinostat, Capecitabine, Metronomic therapy
Medical subject headings
Triple Negative Breast Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • CapecitabineDrug

    Also called xeloda

    500mg orally three times a day (continuously)

  • 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)

Study groups in NCT05390476
Study groupRoleWhat they receive
Tucidinostat and metronomic capecitabine groupExperimentalNot described
Receives: Drug: Capecitabine; Drug: Tucidinostat
metronomic capecitabine groupActive comparatorNot described
Receives: Drug: Capecitabine

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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)

  1. 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

  2. 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

  3. 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.

  1. First posted25 May 2022
  2. Study start1 Aug 2022
  3. Primary completion1 Feb 2024 (estimated)
  4. Study completion1 Dec 2024 (estimated)

Resources

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
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
126 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05390476
Sponsor's protocol ID
SYSUCC-019
Status last verified
Nov 2022
First submitted
21 May 2022
Last updated
4 Nov 2022
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Capecitabine and Tucidinostat in people with Triple Negative 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 4 inclusion and 22 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?

On the ClinicalTrials.gov record for NCT05390476.

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.

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