drugset / Trial / NCT02783222

EFficacy and Impact on Function of Two Different Doses of Nab-paclitaxEl in Elderly With advanCed breasT Cancer

NCT02783222 ↗

Phase 2 Completed 160 enrolled Fondazione Sandro Pitigliani
RandomizedParallel-groupOpen-labelTreatment

Summary

This is a randomized study evaluating the efficacy and impact on function of two different doses of nab-Paclitaxel in elderly patients with advanced breast cancer.

Timeline

Start
2013-01-30
Primary completion
2017-09-22
Completion
2017-12

Outcome

Missed primary endpoint

paper Median EFS was 8.2 months (90% CI, 5.9-8.9; p = 0.188) in arm A vs 8.3 months (90% CI, 6.2-9.7, p = 0.078) in arm B. PMID 32758299 ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject Nab-paclitaxel Small molecule 100 mg/m2 —
Subject Nab-paclitaxel Small molecule 125 mg/m2 —

Indications