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NCT04192331

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

Status unknown Phase 2 Last updated 13 October 2022
What this trial tests

Phase 2 trial testing nab-paclitaxel regimen1 in Breast Cancer in 97 participants. Status unknown.

Timeline
21 February 2019
Primary endpoint
26 January 2023
26 January 2023

Quick facts

Lead sponsorPeking University Cancer Hospital & Institute
PhasePhase 2
StatusStatus unknown
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingnone
Primary purposetreatment
Enrollment97
Start date21 February 2019
Primary completion26 January 2023
Estimated completion26 January 2023
Sites1 location across China

Drugs / interventions tested

Conditions studied

Sponsor

Peking University Cancer Hospital & Institute

Who can join

18 and older, female only, with Breast Cancer. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Substances of Natural Origin in Medicine: Plants vs. Cancer.
    Gielecińska A, Kciuk M, Mujwar S, Celik I, et al · · 2023 · cited 39× · PMID 37048059 · DOI 10.3390/cells12070986
  2. Three-Week Versus 4-Week Schedule of nab-Paclitaxel in Patients With Metastatic Breast Cancer: A Randomized Phase II Study.
    Liu Y, Song G, Di L, Jiang H, et al · · 2023 · cited 2× · PMID 37882706 · DOI 10.1093/oncolo/oyad288

Verify or expand the search:

Other recruiting trials for Breast Cancer

Currently open trials in the same condition.

Other Peking University Cancer Hospital & Institute trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

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