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Treatment with bevacizumab biosimilar-based therapy in breast cancer patients with brain metastases: a real world study

Treatment with bevacizumab biosimilar-based therapy in breast cancer patients with brain metastases: a real world study

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2200061141
Enrollment
Unknown
Registered
2022-06-15
Start date
2022-06-01
Completion date
Unknown
Last updated
2023-03-26

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

Conditions

breast cancer brain metastases

Interventions

bevacizumab biosimilar:bevacizumab biosimilar

Sponsors

Jiangsu Province Hospital
Lead Sponsor

Eligibility

Sex/Gender
Female

Inclusion criteria

Inclusion criteria: 1. Women, voluntarily sign informed consent; 2. ECOG score: 0-2; 3. Patients with brain metastasis of breast cancer diagnosed by histopathology or imaging; 4. According to RECIST 1.1, CT or MRI indicates that there is at least one intracranial focus that can be measured or evaluated by imaging; 5. Estimated survival time >= 3 months.

Exclusion criteria

Exclusion criteria: 1. Allergic to test drug; 2. Within 4 weeks before enrollment, patients with any bleeding or bleeding events >= CTCAE Level 3 or have undergone major surgery or severe traumatic injury, fracture or ulcer; 3. Previous cardiac or thromboembolic events, central nervous system bleeding, uncontrolled hypertension or fistula.

Design outcomes

Primary

MeasureTime frame
intracranial progress free survival, iPFS;

Secondary

MeasureTime frame
intracranial objective response rate, iORR;intracranial disease control rate ,iDCR;objective response rate,ORR;disease control rate,DCR;progress free survival,PFS;overall survival, OS;Occurrence of neurological symptoms;Glucocorticoid use;safety;

Countries

China

Contacts

Public ContactYongmei Yin
ymyin@njmu.edu.cn+86 13951842727

Outcome results

None listed

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