Conditions: Metastatic Breast Cancer
Keywords: Metastatic Breast Cancer Amrubicin
Allocation: NA | Intervention model: SINGLE_GROUP
Enrollment: 78
Healthy volunteers: no

Brief 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.

Arms:
arm 1: Systemic therapy with amrubicin

Interventions: intervention 1: Amrubicin
Intervention descriptions: intervention 1: 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

Protocol document: