NCT01033032

Trial of Amrubicin as Treatment for Patients With HER2-Negative Metastatic Breast Cancer

Phase I/II Trial of Amrubicin as Second- or Third-Line Treatment for Patients With HER2-Negative Metastatic Breast Cancer

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 78 (actual)
• Sponsor: SCRI Development Innovations, LLC · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Doxorubicin has been an integral part of the treatment of women with breast cancer for many years. Since amrubicin may have more activity than doxorubicin, as well as less cardiotoxicity, evaluation of amrubicin in the treatment of advanced breast cancer should be a priority. In this Phase II study, the investigators propose an evaluation of single-agent amrubicin as second- or third-line treatment for women with metastatic breast cancer.

Detailed description

This will be a phase I/II study where phase I will evaluate the maximum tolerated dose of amrubicin, and phase II will assess the progression free survival of patients with HER2-negative metastatic breast cancer using the dose established in the phase I portion.

Conditions

• Metastatic Breast Cancer

Interventions

Type	Name	Description
DRUG	Amrubicin	Phase I: dose-escalating portion with the starting dose of amrubicin at 90mg/m\^2 IV q21 days. Dose escalations are as follows: DL2 - 100mg/m\^2; DL3 - 110mg/m\^2; and DL4 - 120mg/m\^2. All cycles are q21 days Phase II: Amrubicin will be administered at the maximum tolerated dose established in Phase I by IV every 21 days

Timeline

• Start date: 2009-12-01
• Primary completion: 2013-07-01
• Completion: 2014-10-01
• First posted: 2009-12-16
• Last updated: 2022-05-03
• Results posted: 2015-01-06

Locations

16 sites across 1 country: United States