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This study is a randomized controlled study.The primary objective is to evaluate the Progression-Free Survival(PFS) of Utidelone Capsule combined with Capecitabine compared with Utidelone Injection combined with Capecitabine in patients with HER-2 negative advanced breast cancer.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Utidelone Capsule combined with Capecitabine | Experimental |
| |
| Utidelone Injection combined with Capecitabine | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Utidelone Capsule | Drug | Utidelone Capsule: 60 mg/m2/d, administered once a day orally continuously for 5 days from day 1 to day 5, with a treatment cycle of 21 days. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Progression-Free Survival | To evaluate the Progression-Free Survival (PFS) of Utidelone capsules combined with Capecitabine compared with Utidelone Injection combined with Capecitabine | 6 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Objective Response Rate | The percentage of patients who have a partial response or complete response to the treatment. | 6 weeks |
| Disease Control Rate | The proportion of patients who achieve a complete response , partial response , or stable disease as their best overall response. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Rongguo Qiu | Contact | 010-56315388 | Rqiu2001@yahoo.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cancer Hospital Chinese Academy of Medical Sciences | Beijing | China |
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| Utidelone Injection | Drug | Utidelone Injection:30 mg/m2/d, administered once a day intravenously, continuously for 5 days from day 1 to day 5, with a treatment cycle of 21 days. |
|
| Capecitabine | Drug | Capecitabine: 1000mg/m2, twice a day continuously for 14 days from day 1 to day 14, with a 21 day treatment cycle. |
|
| 6 weeks |
| Duration of Response | The time from the first documented objective response to the first documented disease progression or death from any cause, whichever occurs first. | 6 weeks |
| Time to Treatment Failure | The time from randomization to discontinuation of treatment due to any cause | 3 weeks |
| Median treatment cycle | Median number of actual treatment cycles completed by patients | 12 months |
| Treatment-related Adverse Event-TRAE | Number of participants with treatment-related adverse events as assessed by CTCAE v5.0 | 12 months |
| ID | Term |
|---|---|
| D000069287 | Capecitabine |
| ID | Term |
|---|---|
| D003841 | Deoxycytidine |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D005472 | Fluorouracil |
| D014498 | Uracil |
| D011744 | Pyrimidinones |
| D003853 | Deoxyribonucleosides |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
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