Spots Global Cancer Trial Database for Nab-paclitaxel Dose Schedual for HER-2 Negative Advanced Breast Cancer

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Trial Identification

Brief Title: Nab-paclitaxel Dose Schedual for HER-2 Negative Advanced Breast Cancer

Official Title: A Single-arm Opened Randomized Phase II Study of Nab-paclitaxel Dose Schedual in Advanced Breast Cancer

Study ID: NCT04192331

Conditions

Breast Cancer

Interventions

nab-paclitaxel regimen1

nab-paclitaxel regimen2

Study Description

Brief Summary: 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.

Detailed Description: