Open-label, prospective, multicenter, real-world observational clinical study of iribulin mesylate injection in the treatment of locally advanced or metastatic breast cancer

Status

Active, not recruiting

Phases

Phase 4

Study type

Observational

Source

ChiCTR

Registry ID

ChiCTR2100044109

Enrollment

Unknown

Registered

2021-03-11

Start date

2021-03-18

Completion date

Unknown

Last updated

2021-07-21

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

Conditions

Locally advanced or metastatic breast cancer

Interventions

case series:Nil

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. Subjects aged at least 18 years old and voluntary consent and signed written informed consent. 2. ECOG-PS <= 2. 3. Subjects diagnosed with locally advanced (Stage III B, Stage III c ) or metastatic (Stage IV) breast cancer. 4. At least one measurable/evaluable lesion in imaging examination before treatment. 5. Have not used Iribulin mesylate injection before participating in this clinical study. 6. Plan to use Iribulin mesylate injection for treatment. 7. Survival expectation of 3 months or longer. 8. Relevant pathological examination results, such as ER, PR, Ki67 and HER2, can be provided. 9. For females of childbearing potential, pregnancy test before dosing must be negative and agree to take appropriate measures to avoid pregnancy during study treatment and for at least half a year after completion of treatment; Males must agree to use appropriate contraception during the study treatment and for at least six months after the end of treatment. 10. Traceable medical history during treatment.

Exclusion criteria

Exclusion criteria: 1. Pregnant or lactating females. 2. Active infections requiring systemic treatment. 3. HIV-seropositive. 4. Having or suspected to have a central nervous system disease. 5. Subjects with hypersensitivity to halichondrins B and/or the chemical derivatives of halichondrins B. 6. Active pulmonary tuberculosis. 7. Serious heart disease (including serious arrhythmia). 8. Subjects with brain or meninges metastases. 9. Pulmonary lymphatic involvement leading to pulmonary dysfunction, which requires active treatment, including the use of oxygen. 10. Any other situations that the investigator believes the subject is not suitable to participate in this study.

Design outcomes

Primary

Measure	Time frame
Progression-free survival;Objective response rate;	—

Countries

China

Contacts

Public ContactBing-He Xu

Cancer Hospital Chinese Academy of Medical Sciences

xubinghe@medmail.com.cn+86 13501028690

Outcome results

None listed

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