Trials / Unknown
UnknownNCT04192331
Nab-paclitaxel Dose Schedual for HER-2 Negative Advanced Breast Cancer
A Single-arm Opened Randomized Phase II Study of Nab-paclitaxel Dose Schedual in Advanced Breast Cancer
- Status
- Unknown
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 97 (estimated)
- Sponsor
- Peking University Cancer Hospital & Institute · Academic / Other
- Sex
- Female
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | nab-paclitaxel regimen1 | nab-paclitaxel regimen1 means use abraxine with 125mg/m2 at day 1 and day 8 per 21d. |
| DRUG | nab-paclitaxel regimen2 | nab-paclitaxel regimen2 means use abraxine with 125mg/m2 at day 1 and day 8 and day 15 per 28d. |
Timeline
- Start date
- 2019-02-21
- Primary completion
- 2023-01-26
- Completion
- 2023-01-26
- First posted
- 2019-12-10
- Last updated
- 2022-10-13
Locations
1 site across 1 country: China
Source: ClinicalTrials.gov record NCT04192331. Inclusion in this directory is not an endorsement.