A Pivotal Phase II Clinical Trial of Utidelone Injection Plus Capecitabine in HER2-negative Breast Cancer Patients With Brain Metastases

November 26, 2025 updated by: Biostar Pharma, Inc.

A Pivotal Phase II Clinical Trial of Utidelone Injection (UTD1) Plus Capecitabine (CAP) in HER2-negative Breast Cancer Patients With Brain Metastases

This study is a multicenter, two-stage clinical trial to evaluate the efficacy and safety of utidelone in combination with capecitabine in patients with HER2-negative breast cancer with brain metastases. Patients will be enrolled to receive treatment of utidelone alone or in combination with capecitabine.

The objectives both in stage I and stage II are to evaluate the intracranial and systemic efficacy and safety of utdelone plus capecitabine for the treatment of HER2-negative breast cancer patients with brain metastases.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

120

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • California
      • Duarte, California, United States, 91010
        • Not yet recruiting
        • City of Hope--Duarte
        • Contact:
        • Principal Investigator:
          • Dr. Hope S. Rugo
      • Los Alamitos, California, United States, 90720
        • Recruiting
        • Cancer & Blood Research Center, LLC
        • Contact:
        • Principal Investigator:
          • Dr. Vu Phan
      • Los Angeles, California, United States, 90095
        • Not yet recruiting
        • Univ. of California Los Angeles
        • Contact:
        • Principal Investigator:
          • Rena Callahan
      • Oxnard, California, United States, 93030
        • Recruiting
        • FOMAT Medical Research (Network)
        • Contact:
        • Principal Investigator:
          • Dr. Nawazish Khan
      • San Diego, California, United States, 92121
    • Colorado
      • Aurora, Colorado, United States, 80045
        • Recruiting
        • University of Colorado Hospital - Anschutz Cancer Pavilion
        • Contact:
        • Principal Investigator:
          • Dr. Elena Shagisultanova
    • Florida
      • Hialeah, Florida, United States, 33013
        • Recruiting
        • Biosresearch Partner
        • Contact:
        • Principal Investigator:
          • Dr. Luis Rangel
      • Margate, Florida, United States, 33063
        • Recruiting
        • D&H Cancer Research Center
        • Contact:
        • Principal Investigator:
          • Dr. Emilio Araujo-Mino
    • Georgia
      • Augusta, Georgia, United States, 30912
        • Recruiting
        • Augusta University
        • Contact:
        • Principal Investigator:
          • Dr. Priyanka Raval
    • Illinois
      • Chicago, Illinois, United States, 60611
        • Recruiting
        • Robert H. Lurie Comprehensive Cancer Center Northwestern University
        • Contact:
        • Principal Investigator:
          • Dr. Regina Stein
    • Maryland
      • Baltimore, Maryland, United States, 21287
        • Not yet recruiting
        • The Johns Hopkins Sidney Kimmel Cancer Center, Johns Hopkins School of Medicine
        • Contact:
        • Principal Investigator:
          • Solmaz Sahebjam
    • Michigan
      • Farmington Hills, Michigan, United States, 48334
    • Nevada
      • Las Vegas, Nevada, United States, 89169
        • Recruiting
        • Comprehensive Cancer Centers of Nevada
        • Contact:
        • Principal Investigator:
          • Dr. Liawaty Ho
    • New York
      • Stony Brook, New York, United States, 11794-7263
    • Texas
      • Houston, Texas, United States, 77030
        • Recruiting
        • MD Anderson Cancer Center
        • Contact:
        • Principal Investigator:
          • Dr. Nuhad Ibrahim
      • Kingwood, Texas, United States, 22751
      • Webster, Texas, United States, 77598
        • Recruiting
        • Tranquil Clinical Research
        • Contact:
        • Principal Investigator:
          • Dr. John G. Knecht III

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Have histologically confirmed HER2-negative metastatic breast cancer. HER2-negative defined as immunohistochemical (IHC) score of 0 or 1+, or IHC2+ with negative HER2 expression on in situ hybridization (ISH).
  2. Based on screening contrast-enhanced brain MRI, patients must have at least one measurable intracranial lesion according to RECIST 1.1 (≥1.0 cm in size) .
  3. Male or female aged ≥18 years.
  4. ECOG PS 0 or 1.
  5. Have a life expectancy of at least 3 months.
  6. Have adequate baseline hematologic parameters.
  7. Have adequate hepatic and renal function.
  8. ≤ 3 prior lines of chemotherapy in advanced or metastatic setting.
  9. Women of childbearing potential, unless hysterectomy or oophorectomy or postmenopausal for at least 12 consecutive months, must use an effective method of avoiding pregnancy (including oral, transdermal, or implanted contraceptives [any hormonal method in conjunction with a secondary method], intrauterine device, female condom with spermicide, diaphragm with spermicide, absolute sexual abstinence, use of condom with spermicide by sexual partner or sterile [at least 6 months prior to study drug administration] sexual partner) for at least 4 weeks prior to study drug administration, during study and up to 6 months following the last dose of study drug. Cessation of birth control after this point should be discussed with a responsible physician. Investigator will discuss with patient on the above points and the patient agreement will be documented in the source document. The investigator should ensure that the patient is using an effective method of avoiding pregnancy as per protocol. In case of Male patients: Either patient partners or patients themselves must use an effective method of avoiding pregnancy for at least 4 weeks prior to study drug administration, during study and up to 6 months following the last dose.
  10. Patients must be able to follow the study visit schedule, and must be able of sign and give informed consent in accordance with institutional review board.

Exclusion Criteria:

  1. Leptomeningeal metastasis confirmed by MRI and/or cerebrospinal fluid cytology.
  2. Any intracranial lesion thought to require immediate local therapy, including (but not limited to) a lesion in an anatomic site where increase in size or possible treatment-related edema may pose risk to patient (e.g. brain stem lesions).
  3. Have poorly controlled (> 1/week) generalized or complex partial seizures, or manifest neurologic progression due to brain metastases notwithstanding CNS-directed therapy.
  4. Had evidence of intracranial hemorrhage within 3 months before study treatment.
  5. Had evidence of hemoptysis within 6 months before study treatment. Or bleeding or evidence of coagulopathy within 4 weeks before study treatment.
  6. Undergone major surgical procedures within 4 weeks or not fully recovered from surgery before study treatment.
  7. Patients who have received anti-tumor therapies less than 2 weeks before the first dose of investigational product, including endocrine therapy, chemotherapy, radiotherapy, biotherapy, targeted therapy, immunotherapy or antibody-drug conjugate therapy.
  8. Persistent toxicities caused by previous antitumor therapy (excluding alopecia), not yet improved to CTCAE v5.0 grade ≤ 1 or baseline.
  9. Patients with neuropathy> grade 1.
  10. Known hypersensitivity to any components of the investigational product.
  11. Known deficiency of dihydropyrimidine dehydrogenase (DPD).
  12. This applies only to the combination cohort and does not apply to the monotherapy cohort. For patients with previous capecitabine treatment, the prior use of capecitabine meets any of the following criteria: A) The best response during prior capecitabine combination therapy or monotherapy is Progressive Disease (PD); B) Have received capecitabine treatment within 6 months prior to the first study treatment.
  13. Patients who are pregnant (positive pregnancy test) or lactating.
  14. Patients with other malignancies over the past 5 years, except for inactive tumors with good prognosis, including resected basal cell and squamous cell carcinoma of the skin, in-situ carcinoma of the cervix, or papillary thyroid cancer.
  15. Patients who are particpating in other interventional studies or who are receiving other study treatments (patients who have discontinued other investigational treatments and are in follow-up are eligible for enrollement in this study).
  16. Known active or uncontrolled hepatitis B infection, active syphilis, or HIV infection that is not well controlled; or positive for hepatitis B virus based on the evaluation of results of tests for hepatitis B (HBsAg, anti-HBs, anti-HBc, or HBV DNA) infection at screening.
  17. With a history of severe or uncontrolled diseases.
  18. Autoimmune diseases requiring treatment with systemic glucocorticoids.
  19. Not able to perform contrast-enhanced brain MRI or known contraindications to MRI gadolinium contrast, such as cardiac pacemaker, shrapnel, or eye foreign body.
  20. Patients with a history of other systemic severe diseases or abnormal laboratory findings that would, in the Investigator's judgment, be inappropriate for this study.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: (stage 1) monotherapy group
Drug: Utidelone
Utidelone 30 mg/m2/d i.v, once a day for 5 consecutive days, every 21 days as a treatment cycle.
Experimental: (stage 1) combination group A
Drug: Utidelone in combination with capecitabine
UTD1 25 mg/m2/d i.v, once a day for 5 consecutive days, every 21 days as a treatment cycle plus capecitabine 1000 mg/m2 orally twice a day, for 1 to 14 days, 21 days as a treatment cycle.
Drug: Utidelone in combination with capecitabine
Utidelone 30 mg/m2/d i.v, once a day for 5 consecutive days, every 21 days as a treatment cycle plus capecitabine 1000 mg/m2 orally twice a day, for 1 to 14 days, 21 days as a treatment cycle.
Drug: Utidelone in combination with capecitabine
Utidelone 25 mg/m2/d or 30 mg/m2/d i.v, once a day for 5 consecutive days, every 21 days as a treatment cycle plus capecitabine 1000 mg/m2 orally twice a day, for 1 to 14 days, 21 days as a treatment cycle.
Experimental: (stage 1) combination group B
Drug: Utidelone in combination with capecitabine
UTD1 25 mg/m2/d i.v, once a day for 5 consecutive days, every 21 days as a treatment cycle plus capecitabine 1000 mg/m2 orally twice a day, for 1 to 14 days, 21 days as a treatment cycle.
Drug: Utidelone in combination with capecitabine
Utidelone 30 mg/m2/d i.v, once a day for 5 consecutive days, every 21 days as a treatment cycle plus capecitabine 1000 mg/m2 orally twice a day, for 1 to 14 days, 21 days as a treatment cycle.
Drug: Utidelone in combination with capecitabine
Utidelone 25 mg/m2/d or 30 mg/m2/d i.v, once a day for 5 consecutive days, every 21 days as a treatment cycle plus capecitabine 1000 mg/m2 orally twice a day, for 1 to 14 days, 21 days as a treatment cycle.
Experimental: (stage 2) combination group
Drug: Utidelone in combination with capecitabine
UTD1 25 mg/m2/d i.v, once a day for 5 consecutive days, every 21 days as a treatment cycle plus capecitabine 1000 mg/m2 orally twice a day, for 1 to 14 days, 21 days as a treatment cycle.
Drug: Utidelone in combination with capecitabine
Utidelone 30 mg/m2/d i.v, once a day for 5 consecutive days, every 21 days as a treatment cycle plus capecitabine 1000 mg/m2 orally twice a day, for 1 to 14 days, 21 days as a treatment cycle.
Drug: Utidelone in combination with capecitabine
Utidelone 25 mg/m2/d or 30 mg/m2/d i.v, once a day for 5 consecutive days, every 21 days as a treatment cycle plus capecitabine 1000 mg/m2 orally twice a day, for 1 to 14 days, 21 days as a treatment cycle.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Intracranial Objective Response Rate (IC-ORR) evaluated by investigator according to RECIST 1.1 criteria.
Time Frame: 12 months
12 months

Secondary Outcome Measures

Outcome Measure
Time Frame
IC-ORR evaluated by investigator according to Neuro-Oncology Brain Metastases criteria (RANO-BM).
Time Frame: 12 months
12 months
ORR according to RECIST 1.1 criteria.
Time Frame: 12 months
12 months
Progression Free Survival (PFS) according to RECIST 1.1 criteria.
Time Frame: 12 months
12 months
Disease Control Rate (DCR) according to RECIST 1.1 criteria.
Time Frame: 12 months
12 months
Duration of Response (DOR) according to RECIST 1.1 criteria.
Time Frame: 12 months
12 months
Intracranial Progression Free Survival (IC-PFS) according to RECIST 1.1 criteria and RANO-BM.
Time Frame: 12 months
12 months
Intracranial Disease Control Rate (IC-DCR) according to RECIST 1.1 criteria and RANO-BM.
Time Frame: 12 months
12 months
Intracranial Duration of Response (IC-DOR) according to RECIST 1.1 criteria and RANO-BM.
Time Frame: 12 months
12 months
Overall Survival (OS)
Time Frame: up tp 24 months
up tp 24 months
Treatment-emergent Adverse Event-TEAE
Time Frame: Until 28 days after the last dose of treatment
Until 28 days after the last dose of treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Biostar Pharma, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 14, 2025

Primary Completion (Estimated)

January 15, 2027

Study Completion (Estimated)

July 15, 2027

Study Registration Dates

First Submitted

January 7, 2025

First Submitted That Met QC Criteria

January 7, 2025

First Posted (Actual)

January 9, 2025

Study Record Updates

Last Update Posted (Actual)

November 28, 2025

Last Update Submitted That Met QC Criteria

November 26, 2025

Last Verified

November 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BG01-2402

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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