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

NCT01033032 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 78

Last updated 2022-05-03

Study results available
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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.

Conditions

Interventions

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

Sponsors & Collaborators

  • Celgene

    collaborator INDUSTRY

  • SCRI Development Innovations, LLC

    lead OTHER

Principal Investigators

  • Denise A. Yardley, M.D. · SCRI Development Innovations, LLC

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-12-31
Primary Completion
2013-07-31
Completion
2014-10-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01033032 on ClinicalTrials.gov