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

NCT06764940 | Recruiting Phase 2 FDA Drug

• 1 other identifier: BG01-2402
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 17

Brief Summary

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.

Conditions

HER2-negative Breast Cancer Patients With Brain Metastases

Keywords

breast cancer; brain metastases

Outcome Measures

Primary Outcomes (1)

• Intracranial Objective Response Rate (IC-ORR) evaluated by investigator according to RECIST 1.1 criteria.

  12 months

Secondary Outcomes (10)

• IC-ORR evaluated by investigator according to Neuro-Oncology Brain Metastases criteria (RANO-BM).

  12 months

• ORR according to RECIST 1.1 criteria.

  12 months

• Progression Free Survival (PFS) according to RECIST 1.1 criteria.

  12 months

• Disease Control Rate (DCR) according to RECIST 1.1 criteria.

  12 months

• Duration of Response (DOR) according to RECIST 1.1 criteria.

  12 months

Study Arms (4)

(stage 1) monotherapy group

EXPERIMENTAL

Drug: Utidelone

(stage 1) combination group A

EXPERIMENTAL

Drug: Utidelone in combination with capecitabine

(stage 1) combination group B

EXPERIMENTAL

Drug: Utidelone in combination with capecitabine

(stage 2) combination group

EXPERIMENTAL

Interventions

Utidelone DRUG

Utidelone 30 mg/m2/d i.v, once a day for 5 consecutive days, every 21 days as a treatment cycle.

(stage 1) monotherapy group

Utidelone in combination with capecitabine DRUG

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.

(stage 1) combination group B

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).
• 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) .
• Male or female aged ≥18 years.
• ECOG PS 0 or 1.
• Have a life expectancy of at least 3 months.
• Have adequate baseline hematologic parameters.
• Have adequate hepatic and renal function.
• ≤ 3 prior lines of chemotherapy in advanced or metastatic setting.
• 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.
• 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.

You may not qualify if:

• Leptomeningeal metastasis confirmed by MRI and/or cerebrospinal fluid cytology.
• 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).
• Have poorly controlled (\> 1/week) generalized or complex partial seizures, or manifest neurologic progression due to brain metastases notwithstanding CNS-directed therapy.
• Had evidence of intracranial hemorrhage within 3 months before study treatment.
• Had evidence of hemoptysis within 6 months before study treatment. Or bleeding or evidence of coagulopathy within 4 weeks before study treatment.
• Undergone major surgical procedures within 4 weeks or not fully recovered from surgery before study treatment.
• 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.
• Persistent toxicities caused by previous antitumor therapy (excluding alopecia), not yet improved to CTCAE v5.0 grade ≤ 1 or baseline.
• Patients with neuropathy\> grade 1.
• Known hypersensitivity to any components of the investigational product.
• Known deficiency of dihydropyrimidine dehydrogenase (DPD).
• 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.
• Patients who are pregnant (positive pregnancy test) or lactating.
• 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.
• 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).

Sponsors & Collaborators

• Biostar Pharma, Inc.: lead

Study Sites (17)

City of Hope--Duarte

Duarte, California, 91010, United States

NOT YET RECRUITING

Cancer & Blood Research Center, LLC

Los Alamitos, California, 90720, United States

RECRUITING

Univ. of California Los Angeles

Los Angeles, California, 90095, United States

NOT YET RECRUITING

FOMAT Medical Research (Network)

Oxnard, California, 93030, United States

RECRUITING

Scripps Health

San Diego, California, 92121, United States

RECRUITING

University Of Colorado Hospital - Anschutz Cancer Pavilion

Aurora, Colorado, 80045, United States

RECRUITING

Biosresearch Partner

Hialeah, Florida, 33013, United States

RECRUITING

D&H Cancer Research Center

Margate, Florida, 33063, United States

RECRUITING

Augusta University

Augusta, Georgia, 30912, United States

RECRUITING

Robert H. Lurie Comprehensive Cancer Center Northwestern University

Chicago, Illinois, 60611, United States

RECRUITING

The Johns Hopkins Sidney Kimmel Cancer Center, Johns Hopkins School of Medicine

Baltimore, Maryland, 21287, United States

NOT YET RECRUITING

Profound Research LLC

Farmington Hills, Michigan, 48334, United States

RECRUITING

Comprehensive Cancer Centers of Nevada

Las Vegas, Nevada, 89169, United States

RECRUITING

Stony Brook Cancer Center

Stony Brook, New York, 11794-7263, United States

RECRUITING

MD Anderson Cancer Center

Houston, Texas, 77030, United States

RECRUITING

Community Clinical Trials

Kingwood, Texas, 22751, United States

RECRUITING

Tranquil Clinical Research

Webster, Texas, 77598, United States

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms; Brain Neoplasms

Interventions

Capecitabine

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Central Nervous System Neoplasms; Nervous System Neoplasms; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Fluorouracil; Uracil; Pyrimidinones; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides

Central Study Contacts

Simon Guan

CONTACT

+86 10 67864938; simon.guan@biostar-pharma.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 7, 2025
• First Posted: January 9, 2025
• Study Start: July 14, 2025
• Primary Completion (Estimated): January 15, 2027
• Study Completion (Estimated): July 15, 2027
• Last Updated: November 28, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (17)