CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 78 enrolled
Drug / intervention
Amrubicindrug
Likely dose
Amrubicin 90mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01033032
NCT01033032Phase 2Completed
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Phase I/II Trial of Amrubicin as Second- or Third-Line Treatment for Patients With HER2-Negative Metastatic Breast Cancer

SCRI Development Innovations, LLC·interventional·Posted Dec 16, 2009·Updated May 3, 2022

In Brief

A Phase 2 clinical trial evaluating Amrubicin for Metastatic Breast Cancer. Completed, enrolled 78 participants across 16 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMetastatic Breast Cancer
CountriesUnited States
CollaboratorsCelgene

Timeline

Phase 2CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedDec 16, 2009
Enrollment StartDec 1, 2009
Primary CompletionJul 1, 2013
Study CompletionOct 1, 2014
TodayJul 2, 2026
Enrollment to primary: 3.6 yearsPosted 16.5 years ago

Interventions

Amrubicindrug

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