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Recruiting INTERVENTIONAL NCT05398861

Utidelone Combined With Bevacizumab in the Treatment of ≥ 2 Lines of HER-2 Negative Advanced Breast Cancer

A Single-arm, Prospective, Open-label Phase II Clinical Study of Utidelone Combined With Bevacizumab in the Treatment of ≥ 2 Lines of HER-2 Negative Advanced Breast Cancer

Sponsor: Beijing Biostar Pharmaceuticals Co., Ltd.

Updated 6 times since 2022 Last updated: Apr 13, 2026 Started: Aug 19, 2022 Primary completion: Dec 30, 2026 Completion: May 30, 2027
This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

A observational or N/A phase clinical study on HER-2 Negative Breast Cancer, this trial is actively recruiting participants. The trial is conducted by Beijing Biostar Pharmaceuticals Co., Ltd. and has accumulated 6 data snapshots since 2022. Oncology trials at this stage typically focus on safety, tolerability, and early efficacy signals.

Study Description(click to expand)

Patients included were patients with ≥ 2 lines of HER2-negative advanced breast cancer who had previously failed taxanes and/or anthracyclines, or patients with hormone receptor-positive HER2-negative advanced breast cancer who had progressed after at least 1 line of prior endocrine therapy. This study used a Simon two-stage design. 71 subjects will be enrolled using the optimal design.

Patients included were patients with ≥ 2 lines of HER2-negative advanced breast cancer who had previously failed taxanes and/or anthracyclines, or patients with hormone receptor-positive HER2-negative advanced breast cancer who had progressed after at least 1 line of prior endocrine therapy.

This study used a Simon two-stage design. 71 subjects will be enrolled using the optimal design.

Status Flow

~Jul 2022 – ~Feb 2023 · 7 months · monthly snapshotNot Yet Recruiting~Feb 2023 – ~Jul 2024 · 17 months · monthly snapshotNot Yet Recruiting~Jul 2024 – ~Sep 2024 · 2 months · monthly snapshot~Sep 2024 – ~Feb 2025 · 5 months · monthly snapshotNot Yet Recruiting~Feb 2025 – ~Apr 2026 · 14 months · monthly snapshotUnknownApr 17, 2026 – present · 3 months · daily API

Change History

6 versions recorded
  1. Apr 17, 2026 — Present [daily]

    Recruiting

    Status: UnknownRecruiting · Phase: PHASE2None

  2. Feb 2025 — Apr 2026 [monthly]

    Unknown PHASE2

    Status: Not Yet RecruitingUnknown

  3. Sep 2024 — Feb 2025 [monthly]

    Not Yet Recruiting PHASE2

  4. Jul 2024 — Sep 2024 [monthly]

    Not Yet Recruiting PHASE2

  5. Feb 2023 — Jul 2024 [monthly]

    Not Yet Recruiting PHASE2

Show 1 earlier version
  1. Jul 2022 — Feb 2023 [monthly]

    Not Yet Recruiting PHASE2

    First recorded

Eligibility Summary

This study is a prospective, single-arm, open-label phase II study to evaluate the efficacy and safety of the combination of Utidelone and bevacizumab regimen in patients with ≥ 2 lines of HER-2 negative advanced breast cancer.

Contact Information

Sponsor contact:
  • Beijing Biostar Pharmaceuticals Co., Ltd.
  • Henan Cancer Hospital
  • Qilu Pharmaceutical Co., Ltd.
Data source: ClinicalTrials.gov

For direct contact, visit the study record on ClinicalTrials.gov .

Study Locations