Exploratory study on the efficacy of utidelone combined with capecitabine and bevacizumab in the treatment of brain metastasis of HER2 negative breast cancer

Status

Recruiting

Phases

Early Phase 1

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR2200055254

Enrollment

Unknown

Registered

2022-01-04

Start date

2022-02-07

Completion date

Unknown

Last updated

2023-01-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

breast cancer

Interventions

Experimental group:utidelone combined with capecitabine and bevacizumab

Eligibility

Sex/Gender

Female

Age

18 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1. Female patients aged 18-70 years; 2. ECOG 0-2 points; 3. MR enhancement showed measurable brain parenchymal metastases (>= 1, maximum diameter >= 10 mm); 4. Histologically confirmed breast cancer, primary and/or metastatic HER2 negative expression: immunohistochemical 0 or 1+ or 2+ no amplification of HER2 detected by fluorescence in situ hybridization (FISH); 5. Patients with obvious central nervous system symptoms can be screened for >= 1 week after the end of whole brain radiotherapy or stereotactic radiotherapy, and patients without obvious symptoms above can be screened immediately; 6. Previously received anthracycline or taxane chemotherapy; 7. Can be combined with extracranial metastases (such as liver, lung, bone and lymph node metastasis), but without visceral crisis; 8. Blood routine, liver function, renal function and other evaluations can tolerate treatment (neutrophils >= 1.5 x 10^9/L, platelets >= 100 x 10^9/L, Hb >= 85g/L; ALT = 50ml/min).

Exclusion criteria

Exclusion criteria: 1. Pregnancy and lactation; 2. Those who are known to be severely allergic to fluorouracil or polyoxyethylene (35) castor oil or humanized antibodies; 3. Patients who must use solivudine or its congeners (such as brivudine); 4. Hypertension that cannot be controlled by drugs (systolic blood pressure > 180mmHg, diastolic blood pressure > 110mmHg); 5. Left ventricular ejection fraction < 50%; 6. Active bleeding; 7. Arterial thromboembolism; 8. Pulmonary embolism; 9. Have ever had grade IV peripheral neuropathy; 10. Cancerous meningitis; 11. Brain metastases caused by other primary tumors other than breast cancer.

Design outcomes

Primary

Measure	Time frame
objective respoinse rate;	—

Secondary

Measure	Time frame
intracranial clinical benefit rate;the first progression site;intracranial progression free survival;extracranial progression free survival;overall survival;side effect;	—

Countries

China

Contacts

Public ContactChu Zhaohui

Huashan Hospital Affiliated to Fudan University

zhaohuichu5196@qq.com+86 18049870155

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026