Efficacy and Safety of Utidelone Capsule and Utidelone Injection in Patients With HER-2 Negative Advanced Breast Cancer

NCT07684456 | Not Yet Recruiting Phase 3

• 1 other identifier: BG02-2601
• Study Type: interventional
• Target: 308
• Locations: 1 country
• Sites: 1

Brief Summary

This study is a randomized controlled study.The primary objective is to evaluate the Progression-Free Survival(PFS) of Utidelone Capsule combined with Capecitabine compared with Utidelone Injection combined with Capecitabine in patients with HER-2 negative advanced breast cancer.

Conditions

Advanced Breast Cancer

Outcome Measures

Primary Outcomes (1)

• Progression-Free Survival

  To evaluate the Progression-Free Survival (PFS) of Utidelone capsules combined with Capecitabine compared with Utidelone Injection combined with Capecitabine

  6 weeks

Secondary Outcomes (6)

• Objective Response Rate

  6 weeks

• Disease Control Rate

  6 weeks

• Duration of Response

  6 weeks

• Time to Treatment Failure

  3 weeks

• Median treatment cycle

  12 months

Study Arms (2)

Utidelone Capsule combined with Capecitabine

EXPERIMENTAL

Drug: Utidelone Capsule; Drug: Capecitabine

Utidelone Injection combined with Capecitabine

ACTIVE COMPARATOR

Drug: Utidelone Injection; Drug: Capecitabine

Interventions

Utidelone Capsule DRUG

Utidelone Capsule: 60 mg/m2/d, administered once a day orally continuously for 5 days from day 1 to day 5, with a treatment cycle of 21 days.

Utidelone Capsule combined with Capecitabine

Utidelone Injection DRUG

Utidelone Injection：30 mg/m2/d, administered once a day intravenously, continuously for 5 days from day 1 to day 5, with a treatment cycle of 21 days.

Utidelone Injection combined with Capecitabine

Capecitabine DRUG

Capecitabine: 1000mg/m2, twice a day continuously for 14 days from day 1 to day 14, with a 21 day treatment cycle.

Utidelone Capsule combined with Capecitabine; Utidelone Injection combined with Capecitabine

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients who have fully understood the objectives, content, process of the study and possible adverse events, voluntarily serves as a subject and signs the informed consent form.
• Subjects aged ≥18 and ≤75.
• Male or female subjects with ECOG performance status scored 0-1.
• Patients who were diagnosed with HER-2 negative advanced breast cancer by histopathology.
• Patients with locally advanced,recurrent,or metastatic breast cancer.
• Patients who had received chemotherapy regimens, including at least one taxanes or anthracyclines.
• Patients with hormone receptor positive should have disease progression after endocrine therapy.
• At least one measurable lesion present according to RECIST 1.1 criteria.
• Expected survival time ≥ 12 weeks
• Baseline routine blood tests is normal.
• Liver and kidney function test results are normal.
• Fertile males and females of childbearing potential must agree to use effective contraception (so do their partners, using hormonal or barrier contraception, or abstinence) during the study and within at least 6 months after the last dose. The blood or urine pregnancy test for female patients of childbearing potential prior to enrollment must be negative.

You may not qualify if:

• Patients who have received non-investigational anti-tumor therapies within 4 weeks prior to study drug administration.
• Patients who have used Capecitabine or Utidelone within 6 months prior to randomization.
• Patients with breast cancer with CNS metastases leptomeningeal metastases.
• Patients with uncontrollable bone metastases,existing or recent risk of fracture, recent need for surgery or local radiotherapy, or other critical conditions.
• Patients with uncontrollable pleural effusion,pericardial effusion or ascites requiring repeated drainage(once a month or more)
• Patients with serious cardiovascular disease.
• Patients with mental illnesses which are hard to control, patients who lack legal capacity or have limited legal capacity.
• Patients with gastrointestinal disorders affecting oral administration.
• Patients with active infections and need systemic therapy currently.
• Patients with peripheral neuropathy grade≥2 during randomization.
• Patients with toxicity grade ≥2 which caused by prior anti-tumor therapy.(NCI-CTCAE 5.0,except for what is considered no safety risk such as alopecia by investigator.）
• Patients who have received any major surgery(except for diagnostic procedures such as biopsy）,or have sustained major trauma within 4 weeks to randomization;or is expected to undergo major surgery during the treatment.
• Patients who have received radiotherapy within 2 weeks to randomization.
• Patients who have received interventional therapy in another clinical trail or have received other investigational treatments.
• Patients with other malignant tumor within 5 years to randomization excluding curatively treated cervical carcinoma in situ, cutaneous basal cell carcinoma or squamous cell carcinoma, and papillary thyroid carcinoma.

Sponsors & Collaborators

• Beijing Biostar Pharmaceuticals Co., Ltd.: lead

Study Sites (1)

Cancer Hospital Chinese Academy of Medical Sciences

Beijing, China

Location

MeSH Terms

Interventions

Capecitabine

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

Rongguo Qiu

CONTACT

010-56315388; Rqiu2001@yahoo.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 29, 2026
• First Posted: July 6, 2026
• Study Start: August 1, 2026
• Primary Completion (Estimated): March 1, 2028
• Study Completion (Estimated): March 1, 2029
• Last Updated: July 6, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)