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Triple-negative Breast CancerPhase 2NCT05336721

A Phase II Study of Chiauranib in Combine With Capecitabine in TNBC

A Phase 2 study testing Chiauranib and capecitabine in people with Triple-negative Breast Cancer, run by Chipscreen Biosciences, Ltd. at 4 sites in China.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

This study is to evaluate the preliminary efficacy and safety of chiauranib in combine with capecitabine in advanced triple-negative breast cancer failed to prior anthracyclines and taxanes therapy Read more about this study

Who is it for?
Ages 18 years and older, women only
Conditions the study is for
Triple-negative Breast Cancer
What is being tested?
Chiauranib and capecitabine
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
9 participants
Where
4 sitesChina
Study dates
5 Nov 2021to 5 Nov 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 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • All patients must have given signed, informed consent prior to registration on study
  • age ≥ 18 years
  • female
  • Histological or cytological evidence of estrogen-receptor negative (ER-), progesterone receptor negative (PgR-) and human epidermal growth factor-2 receptor negative (HER2-) Breast Cancer by local laboratory testing.
  • Patients with locally advanced inoperable or recurrent/metastatic TNBC and had failed treatment with anthracyclines and taxanes.
  • At least 1 lesion can be accurately measured, as defined by RECIST1.1
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  • Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1.
  • Laboratory criteria are as follows:
  • 1) Complete blood count: hemoglobin (Hb) ≥90g/L ; absolute neutrophil count (ANC) ≥1.5×109/L ; platelets ≥90×109/L; 2) Biochemistry test: serum creatinine(cr) <1.5×ULN; total bilirubin<1.5×ULN; alanine aminotransferase(ALT) ,aspartateaminotransferase(AST)≤2.5×ULN; (ALT,AST#5×ULN if liver involved) 3) Coagulation test: International Normalized Ratio (INR) < 1.5
  • 9. Life expectancy of at least 3 months

Who cannot join

  • Patients have used any anti-cancer therapy, including adiotherapy, chemotherapy, immunotherapy, target therapy, and other anti-tumor treatments within 28 days before the first dose
  • Patients received vascular endothelial growth factor(VEGF)/vascular endothelial growth factor receptor(VEGFR) inhibitor, like Apatinib, Anlotinib, Fruquintinib, Bevacizumab, etc., or Aurora kinase inhibitors, etc; Patients had treatment of capecitabine (except who received the treatment of capecitabine in Neoadjuvant/ Adjuvant therapy, and Recurrence occurs after 12 months)
  • Has known allegies to Chiauranib, capecitabine or any of the excipients
  • prior major surgery or trauma within 28 days prior to first dose of study drug and/or presence of any non-healing wound, fracture, or ulcer
  • Treatment with an investigational agent/instrument within 28 days prior to first dose of study drug
  • Any ongoing toxicity from prior anti-cancer therapy that is >Grade 1
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  • Patients with prior invasive malignancies in the past five years with the exception of curatively-treated basal cell or squamous cell carcinoma of the skin or cervical carcinoma in situ
  • History or clinical evidence of central nervous system (CNS) metastases or leptomeningeal carcinomatosis
  • Have uncontrolled or significant cardiovascular disease, including:
  • 1) Congestive heart failure, unstable angina pectoris, myocardial infarction within 6 months prior to study entry; arrhythmia, or Left Ventricular Ejection Fraction (LVEF) < 50% requiring treatment with agents during screening stage 2) primary cardiomyopathy(dilated cardiomyopathy, hypertrophic cardiomyocyte, arrhythmogenic right ventricular cardiomyopathy, restrictive cardiomyopathy, et,al) 3) History of significant QT interval prolongation, or Corrected QT Interval (QTc) > 470 ms prior to study entry 4) Symptomatic coronary heart disease requiring treatment with agents 5) History of hypertension treated by≥2 agents, or the Blood pressure(Bp) ≥140/90 mmHg prior to study entry 6) Other condition investigator considered inappropriate
  • 10. CT or MRI of the chest during the screening period shows interstitial lung disease or pulmonary fibrosis or lung inflammation that requires treatment, or within 6 months before the first dose, history of pneumonia requiring oral or intravenous steroid treatment
  • 11. Have clinical significant gastrointestinal abnormality that would impair the ingestion, transportation or absorption of oral agents, history of gastrointestinal perforation or abdominal fistula, peptic ulcer disease within 6 months prior to first dose of study drug
  • 12. Urinary protein ≥ 2+ and quantitative urinary protein ≥ 1g/24 h during the screening period
  • 13. History of active bleeding within the past 2 months, patients with bleeding potential during the screening period, or receiving anticoagulation therapy
  • 14. Pleural fluid, ascites or pericardial effusion with significant symptoms or required treatment of puncture or drainage during the screening period
  • 15. History of deep venous thrombosis or Pulmonary embolism within the past 6 months
  • 16. Active infection requiring oral or intravenous systemic antimicrobial therapy during the screening period
  • 17. Screening for HIV antibody positive
  • 18. Screening test for hepatitis B surface antigen (HBsAg) or hepatitis B core antibody (HBcAb) positive with virus replication, hepatitis C antibody (HCVAb) positive with virus replication
  • 19. Any mental or cognitive disorder, that would impair the ability to understand the informed consent document, or the compliance of study
  • 20. Candidates with drug and alcohol abuse
  • 21. Participants of reproductive potential not willing to use adequate contraceptive measures for the duration of the study.Pregnant or breastfeeding women
  • 22. Any other condition which is inappropriate for the study in the opinion of the investigators

Trial locations and contacts

4 sites in 1 country.

China4 sites

  • The Fifth Medical Center of PLA General Hospital

    Beijing, Beijing Municipality, 8 Fengtai East Street, Fengtai

  • Sun Yat-sen University Cancer Center

    Guangzhou, Guangdong, 510060

  • Jiangsu Province Hospital

    Nanjing, Jiangsu, 210029

  • Henan Cancer Hospital

    Zhengzhou, Henan, 450003

Other trials in China

About this study

Official title: An Open Labelled, Multicenter-phase II Study of Chiauranib Combine With Capecitabine in Advanced Triple-negative Breast Cancer Failed to Prior Anthracyclines and Taxanes Therapy

This study is to evaluate the preliminary efficacy and safety of chiauranib in combine with capecitabine in advanced triple-negative breast cancer failed to prior anthracyclines and taxanes therapy

Read the detailed description

Chiauranib is a novel orally active multi-target inhibitor that simultaneously inhibits the angiogenesis-related kinases (VEGFR2, VEGFR1, VEGFR3,PDGFRa and c-Kit), mitosis-related kinase Aurora B and chronic inflammationrelated kinase CSF-1R in a high potency manner with the IC50 at a single-digit nanomolar range. In particular, Chiauranib showed very high selectivity in the kinase inhibition profile with little activity on off-target nonreceptor kinases, proteins, GPCR and ion channels, indicative of a better drug safety profile in terms of clinical relevance.

This study including two phases: (1) dose-escalation , this phase using a 3+3design，9-18 patients will be enrolled and receive 25mg/35mg/50mg chiauranib and 1000mg/m2 capecitabine Q3W. (2) dose-expansion，About 20 patients will be enrolled and receive the MTD dose of chiauranib and 1000mg/m2 capecitabine Q3W.

This study also to explore the PK variation and gene expression via blood samples

Being tested
Chiauranib, capecitabine
Keywords
Chiauranib；Capecitabine；triple-negative breast cancer
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.

  • ChiauranibDrug

    25mg/35mg/50mg orally once daily

  • capecitabineDrug

    1000mg/m2 on Days 1-14 in a repeating 21-day cycle

Study groups in NCT05336721
Study groupRoleWhat they receive
Experimental: Chiauranib + capecitabineExperimentalPatients receive the combined treatment of Chiauranib plus capecitabine, 21 days as a cycle until objective disease progression.
Receives: Drug: Chiauranib; Drug: capecitabine

What is being measured

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

  1. ORR(Objective reponse rate)

    Overall response rate (ORR) is defined as the percentage of patients with complete or partial response evaluated by RECIST 1.1. Per RECIST 1.1: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR

    Measured: 2years

Secondary outcomes (5)

  1. CBR (Clinical Benefit Rate)

    Clinical Benefit Rate (CBR) will be determined by looking at the number of subjects who have either a complete response, partial response, or stable disease for greater than or equal to 24 weeks, per RECIST 1.1

    Measured: 2years

  2. PFS (Progression-free survival)

    From date of the first dose of study drug until the date of first documented progression or relapse or date of death from any cause, whichever came first,

    Measured: 2years

  3. DoR (Duration of response)

    Measured: 2years

  4. OS(Overall survival)

    Measured: 2years

  5. AEs

    percentage of AEs

    Measured: 2years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Apr 2022
  2. Study start5 Nov 2021
  3. Primary completion31 Oct 2024
  4. Study completion5 Nov 2024

Why it stopped: During the enrollment period of this project, due to the increasing proportion of patients receiving capecitabine adjuvant therapy and the large number of trials competing for the same number of lines in various centers

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
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
9 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05336721
Sponsor's protocol ID
CAR202
Status last verified
Nov 2024
First submitted
14 Apr 2022
Last updated
24 Mar 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Chiauranib and capecitabine in people with Triple-negative Breast Cancer, run by Chipscreen Biosciences, Ltd. at 4 sites 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 10 inclusion and 23 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: stopped early, as of the sponsor's last update on 24 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites 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?

The study was stopped early (reason given: During the enrollment period of this project, due to the increasing proportion of patients receiving capecitabine adjuvant therapy and the large number of trials competing for the same number of lines in various centers). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

ORR(Objective reponse rate) (time frame: 2years). 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 NCT05336721.

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 24 Mar 2025.

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