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What is the best dosage of Nab-Paclitaxel for chinese? This study would divide patients into two dosage groups: 1) 125mg/m2, 30 minutes intravenous injection, d1, 8, 21 days for a cycle(clinical use); 2) 125mg/m2 d1, 8, 15, 30 minutes intravenous injection, 28 days for a cycle(guideline recommand). Treatment to disease progression. The efficacy (CR, PR, SD, PD) is evaluated every 2-4 cycles.If the patient withdraws from the trial because he cannot tolerate the toxicity caused by one of the drugs, such as neurotoxicity or bone marrow toxicity, it is recommended to switch to other drugs and follow up to PFS and OS.Each group was planned to include 30 patients.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 2/3dose strategy | Experimental | HER2 negative advanced breast cancer patient |
|
| 3/4dose strategy | Active Comparator | HER2 negative advanced breast cancer patient |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| nab-paclitaxel regimen1 | Drug | nab-paclitaxel regimen1 means use abraxine with 125mg/m2 at day 1 and day 8 per 21d. |
|
| Measure | Description | Time Frame |
|---|---|---|
| PFS of two regimen | progession free survival and objective remission rate was put in to assessment after 2-4 cycle of treatment of either two regimen | From date of enrollment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months |
| Measure | Description | Time Frame |
|---|---|---|
| Side effect of two regimen | toxicity and tolerability would be evaluated after every cycle of treatment and will report a SAE within 24h | From date of enrollment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months |
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Inclusion criteria
Exclusion Criteria
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| BeijingCancerH | Haidian | Beijing Municipality | 10010 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37882706 | Derived | Liu Y, Song G, Di L, Jiang H, Ran R, Zhang R, Zhang Y, Li H. Three-Week Versus 4-Week Schedule of nab-Paclitaxel in Patients With Metastatic Breast Cancer: A Randomized Phase II Study. Oncologist. 2023 Dec 11;28(12):1102-e1302. doi: 10.1093/oncolo/oyad288. |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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| nab-paclitaxel regimen2 | Drug | nab-paclitaxel regimen2 means use abraxine with 125mg/m2 at day 1 and day 8 and day 15 per 28d. |
|
|
| D017437 |
| Skin and Connective Tissue Diseases |