Breast cancer
Conditions
Interventions
Sponsors
Shandong Cancer Hospital and Institute
Eligibility
Sex/Gender
Female
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Patients voluntarily participate in this study and sign an informed consent form; 2. Female, aged >=18 years and = 12 weeks; 10. Women of childbearing potential must have a negative serum pregnancy test result within 7 days prior to the first dose of study drug and be willing to use adequate contraception during the trial and for 6 months after the final dose of study drug. Women who are menopausal but have not reached post-menopausal status (amenorrhea for 12 consecutive months, with no cause other than menopause) and have not undergone sterilisation (ovarian and/or hysterectomy) are still classified as fertile.
Exclusion criteria
Exclusion criteria: 1. Expected survival time = 2; 3. Active or untreated brain metastases as determined by magnetic resonance imaging (MRI) assessment during screening and previous imaging assessment. Carcinomatous meningitis; 4. Patients expected to be treated with any other systemic or local antitumour therapy during the course of study treatment; 5. Other malignancy = 5 years prior to the first dose; 6. Currently pregnant/lactating women, or women planning to become pregnant during the study and within 6 months of the last dose of study drug; 7. Undergoing local radiotherapy or not recovering from radiotherapy; 8. Known hypersensitivity or allergic reactions to any of the components of Utidelone Injection; 9. Previous use of Utidelone Injection; 10. Any other serious medical condition or clinical laboratory test abnormality that, in the judgment of the investigator, could prevent the patient from safely participating in and completing the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression-free survival; | — |
Secondary
| Measure | Time frame |
|---|---|
| Objective response rate;1-year survival rate;2-year survival rate; | — |
Countries
China
Contacts
Public ContactSong Lihua
Cancer Hospital of Shandong First Medical University
Outcome results
None listed