AzTrials
AzTrials

Breast Cancer RecurrentPhase 2NCT06458413

Utidelone Capsule Plus Capecitabine (CAP) for Metastatic Breast Cancer

A Phase 2 study testing Utidelone Capsule Plus Capecitabine in people with Breast Cancer Recurrent, run by Min Yan, MD at 1 site in China.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
Search all trials

Trial summary

This study aims to investigate the efficacy and safety of utidelone capsule plus Capecitabine in the treatment of advanced breast cancer , and thus provides a new systemic treatment strategy for those patients. Read more about this study

Who is it for?
Ages 18 to 70 years, women only
Conditions the study is for
Breast Cancer Recurrent
What is being tested?
Utidelone Capsule Plus Capecitabine
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
40 participants
Where
1 siteChina
Study dates
6 Jun 2024to 30 Dec 2026
Phase
Phase 2
Are there results?
Not yet: the study is under way

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 70 years
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Voluntarily participate in this study, sign an informed consent form, have good compliance, and are willing to follow-up.
  • Female, aged ≥ 18 and ≤ 70 years, with an ECOG score of 0-1 and an expected survival time of ≥ 12 weeks.
  • The pathological and/or cytological diagnosis (based on the latest biopsy results) is HER2 negative recurrent or metastatic breast cancer, regardless of hormone receptor status (ER/PR positive or negative, but the hormone receptor status needs to be determined);
  • All patients have received at least paclitaxel and/or anthracycline as a treatment option;
  • All patients with prior treatment ≤ 3 lines (for those who progress during the neoadjuvant/adjuvant period or within 12 months after the end of the last treatment, it is considered as the first line, and no progress is counted as the number of lines); For HR+/HER2- breast cancer patients, they also need to have received the first line systemic CDK4/6 inhibitor+endocrine therapy before the disease progresses.
  • According to RECIST 1.1 standard, there is at least one measurable extracranial lesion present.
Show all 12Show fewer
  • Within one week before enrollment, the blood routine examination was basically normal (no blood transfusion within two weeks, no use of drugs to increase white blood cells or platelets):
  • Neutrophil count (ANC) ≥ 1.5 × 109/L; Platelet count (PLT) ≥ 90 × 109/L; Hemoglobin ≥ 9.0 g/dL.
  • Within one week before enrollment, the blood biochemistry test was basically normal (based on the normal values of each research center laboratory): Total bilirubin (TBIL) ≤ 1.5 x Upper limit of normal value (ULN) SGPT/ALT ≤ 3 × ULN (liver metastasis patients ≤ 5 × ULN); SGOT/AST ≤ 3 × ULN (liver metastasis patients ≤ 5 × ULN); The creatinine clearance rate (Ccr) is ≥ 50 ml/min (Cockcroft Gault formula).
  • Adequate coagulation function: defined as international normalized ratio (INR) or prothrombin time (PT) ≤1.5 × ULN. If the subject is receiving anticoagulant therapy, PT is acceptable as long as it is within the target range specified for the anticoagulant.
  • No major organ dysfunction
  • Women with fertility must agree to use effective contraceptive methods during the study period and within 6 months after the last study medication. Women with fertility must have a negative blood or urine pregnancy test before enrollment.

Who cannot join

  • Other malignant tumors within the 5 years prior to enrollment, excluding cured cervical carcinoma in situ, basal cell carcinoma of the skin, papillary thyroid carcinoma without lymph node metastasis, or squamous cell carcinoma of the skin.
  • Those who meet the following conditions:
  • Received systemic anti-tumor therapy within 2 weeks prior to enrollment, including but not limited to endocrine therapy, small molecule targeted therapy, anti-tumor traditional Chinese medicine, etc;
  • Within the 4 weeks prior to enrollment, chemotherapy, targeted biological therapy or immunotherapy, other clinical investigational drugs, radiation therapy, or major organ surgery (excluding biopsy) or significant trauma have been received, or elective surgery is required during the trial period. Those who have undergone major surgeries;
  • Received nitroso urea or mitomycin C within 6 weeks prior to enrollment;
  • Individuals who have previously received treatment with Utidelone injection.
Show all 23Show fewer
  • Peripheral neuropathy CTCAE 5.0 grade evaluation ≥ 2.
  • Those who have received treatment with capecitabine or other drugs with an active ingredient of 5-fluorouracil (excluding those who received neoadjuvant/adjuvant therapy and relapse after more than 12 months of treatment).
  • Pregnant and lactating patients.
  • Adverse reactions from previous anti-tumor treatments have not yet recovered to CTCAE 5.0 grade ≤1 (excluding toxicity judged by researchers to have no safety risk for hair loss).
  • Accompanied by meningeal metastasis; Accompanied by uncontrollable brain metastases (researchers have determined that new asymptomatic brain metastases or those known to have stable brain metastases after treatment can be enrolled); Or uncontrollable bone metastasis, which refers to patients who have or have recently been at risk of fractures or have obvious symptoms or other critical situations.
  • Uncontrollable pleural effusion, pericardial effusion, or abdominal effusion.
  • Individuals with active infections who currently require systematic anti infection treatment.
  • Have a history of immunodeficiency, including HIV antibody testing positive, or have other acquired or congenital immunodeficiency diseases, or have a history of organ transplantation.
  • Individuals with active hepatitis B or hepatitis C; Known active syphilis infection.
  • Have a history of severe cardiovascular and cerebrovascular diseases, including but not limited to:
  • Serious cardiac rhythm or conduction abnormalities, such as ventricular arrhythmias requiring clinical intervention, grade II-III atrioventricular block, etc; At rest, the average QTcF obtained from three 12 lead electrocardiogram examinations is>470ms; Acute coronary syndrome, congestive heart failure or systolic dysfunction (LVEF<50%), aortic dissection, stroke, or other Grade 3 or higher cardiovascular events occurring within 6 months prior to the first administration; Hypertension that cannot be controlled clinically. Other researchers have identified high-risk heart diseases.
  • Uncontrolled diabetes patients.
  • Patients with active gastrointestinal ulcers.
  • Have a clear history of neurological or psychiatric disorders, including epilepsy or dementia.
  • Participate in another clinical trial or use other investigational treatments simultaneously.
  • Individuals known to be allergic to the investigational drug or any of its excipients.
  • The researchers believe that the subjects have a history of other serious systemic diseases or other reasons that make them unsuitable to participate in this trial.

Trial locations and contacts

1 site in 1 country.

China1 site

  • Henan Cancer hospital

    Zhengzhou, Henan

Other trials in China

About this study

Official title: :Single-arm, Phase II Clinical Trial of Utidelone Capsule Plus Capecitabine (CAP) in Patients With Metastatic Breast Cancer

This study aims to investigate the efficacy and safety of utidelone capsule plus Capecitabine in the treatment of advanced breast cancer , and thus provides a new systemic treatment strategy for those patients.

This study was a single-arm, phase II study of patients with recurrent or metastatic HER2-negative breast cancer who had previously received chemotherapy regimens containing taxanes and/or anthracyclines were treated with a combination of utidelone capsules and capecitabine. The main objective was to explore the efficacy and safety of the combined regimen.

Read the detailed description

Patients with recurrent or metastatic HER2 negative breast cancer who have previously received chemotherapy containing taxanes and/or anthracyclines will receive combined treatment with utidelone capsule and capecitabine. Utidelone Capsule: 60mg/m2/d, once daily, oral on an empty stomach, continuously administered for 1-5 days; Capecitabine tablets: 1000mg/m2, twice a day (daily dose 2000mg/m2), once in the morning and once in the evening, taken orally within 30 minutes after meals, and continuously administered for 14 days from day 1 to day 14. Every 21 days is a cycle until disease progression, intolerable adverse events occur, subjects voluntarily withdraw, or the researcher determines that medication must be terminated.

Being tested
Utidelone Capsule Plus Capecitabine

What participants receive

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

  • Utidelone Capsule Plus CapecitabineDrug

    Utidelone Capsule: 60mg/m2/d, once daily, oral on an empty stomach, continuously administered for 1-5 days; Capecitabine tablets: 1000mg/m2, twice a day (daily dose 2000mg/m2), once in the morning and once in the evening, taken orally within 30 minutes after meals, and continuously administered for 14 days from day 1 to day 14.

    Every 21 days is a cycle .

Study groups in NCT06458413
Study groupRoleWhat they receive
Single-armExperimentalPatients with HER2-negative breast cancer were treated with Utidelone Capsule combined with Capecitabine tablets.
Receives: Drug: Utidelone Capsule Plus Capecitabine

What is being measured

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

  1. Objective Response Rate （ORR）

    ORR is defined as the percentage of participants in the analysis population who have CR or PR per RECIST 1.1.

    Measured: 18 months

Secondary outcomes (5)

  1. Progression-Free Survival（PFS）

    time from the first dose to disease progression or any-cause death

    Measured: 18 months

  2. Disease Control Rate （DCR）

    DCR is defined as the percentage of participants in the analysis population who have CR or PR or SD per RECIST 1.1.

    Measured: 18 months

  3. Duration of response (DoR)

    DOR is defined as the interval from response initiation (when either CR or PR is first determined) to progression or death, whichever occurs first.

    Measured: 18 months

  4. Overall survival (OS)

    time from the first dose of study drug to any-cause death

    Measured: 18 months

  5. Treatment-related Adverse Event-TRAE

    Number of participants with treatment-related adverse events as assessed by CTCAE v5.0

    Measured: Until 28 days after the last dose of treatment

Timeline

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

  1. First posted13 Jun 2024
  2. Study start6 Jun 2024
  3. Primary completion9 Jul 2026
  4. Study completion30 Dec 2026 (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
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
40 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06458413
Sponsor's protocol ID
HNCH-MBC16
Status last verified
Oct 2026
First submitted
10 Jun 2024
Last updated
16 Oct 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: Individual participant data that underlie the results reported in this article, after de-identification are available following article publication.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Utidelone Capsule Plus Capecitabine in people with Breast Cancer Recurrent, run by Min Yan, MD 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 12 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: under way, not looking for participants, as of the sponsor's last update on 16 Oct 2026. 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?

This study is still under way. Results are not available in the source record yet.

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?

Objective Response Rate （ORR） (time frame: 18 months). 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 NCT06458413.

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 16 Oct 2026.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in