drugset / Trial / NCT03712956

CAELYX® as Adjuvant Treatment in Early Stage Luminal B Breast Cancer BREAST CANCER

NCT03712956 ↗

NaSingle-groupOpen-labelTreatment

Summary

A single-center, phase II, single-arm, feasibility study to evaluate PLD (Caelyx®) as an adjuvant chemotherapy regimen in patients with early-stage luminal B breast cancer. The primary endpoint will be to evaluate the feasibility of adjuvant PLD (Caelyx®) for each individual subject. The regimen will be considered feasible if that subject is able to achieve relative dose intensity (RDI) of at least 85% of the 8 cycles of treatment. Caelyx® should be administered intravenously at a dose of 20 mg/m2 once every two weeks for 8 courses.

Timeline

Start
2016-03-25
Primary completion
2023-12-31
Completion
2023-12-31

Drugs

EvaluationDrugModalityDoseRoute
Subject Doxorubicin Other / unclassified 20 mg/m2 Intravenous

Indications