Study of Amrubicin With or Without Herceptin in Patients With Metastatic Breast Cancer

September 22, 2008 updated by: Celgene Corporation

A Phase 2 Trial of Amrubicin With or Without Herceptin in the Treatment of Metastatic Breast Cancer

The purpose of the study is to evaluate the incidence of cardiac toxicity of amrubicin when administered to patients with metastatic breast cancer.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

66

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Connecticut
      • New Milford, Connecticut, United States, 06776
      • Sharon, Connecticut, United States, 06069
      • Torrington, Connecticut, United States, 06790
    • Minnesota
      • Burnsville, Minnesota, United States, 55337
      • Edina, Minnesota, United States, 55435-2150
      • Maplewood, Minnesota, United States, 55109
      • Minneapolis, Minnesota, United States, 55404
      • St. Paul, Minnesota, United States, 55102-2389
      • Woodbury, Minnesota, United States, 55125
    • Missouri
      • Columbia, Missouri, United States, 65201
    • New York
      • Albany, New York, United States, 12208
      • Amsterdam, New York, United States, 12010
      • Hudson, New York, United States, 12534
      • Latham, New York, United States, 12110-0610
      • Rexford, New York, United States, 12148
      • Schenectady, New York, United States, 12308
      • Troy, New York, United States, 12180
    • North Carolina
      • Asheville, North Carolina, United States, 28803
    • Texas
      • Dallas, Texas, United States, 75246
      • Dallas, Texas, United States, 75230-2510
      • Dallas, Texas, United States, 75231-4400
      • El Paso, Texas, United States, 79902
      • El Paso, Texas, United States, 79915
      • Houston, Texas, United States, 77024
      • Midland, Texas, United States, 79701-5946
      • Odessa, Texas, United States, 79761
      • Plano, Texas, United States, 75075-7787
      • Tyler, Texas, United States, 75702

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Histological or cytological diagnosis of breast cancer.
  • Metastatic or recurrent disease, either HER2+ (FISH+ or 3+ IHC) or HER2-.
  • Maximal dose of prior adjuvant anthracycline: 300 mg/meters squared doxorubicin or equivalent. Relapse greater than one year after trastuzumab adjuvantly; two years following adjuvant anthracycline therapy (without trastuzumab).
  • One prior chemotherapy for metastatic breast cancer allowed (may include trastuzumab for HER2+ patients), but no prior Doxil, adriamycin or epirubicin for metastatic breast cancer.
  • At least 18 years of age.
  • ECOG Performance Status of 0, 1, or 2.

  • Adequate organ function including the following:

    • Adequate bone marrow reserve.
    • Cardiac: Left ventricular ejection fraction (LVEF) greater than or equal to 55% by MUGA.
  • Negative serum pregnancy test at the time of enrollment for women of child-bearing potential.
  • Ability to understand the requirements of the study, provide written informed consent and authorization of use and disclosure of protected health information, and agree to abide by the study restrictions and to return for the required assessments.

Exclusion Criteria:

  • Pregnant or nursing women.
  • Concurrent anticancer therapy.
  • Participation in any investigational drug study within 28 days prior to study entry.
  • Concurrent severe or uncontrolled medical disease (i.e., active systemic infection, diabetes, uncontrolled hypertension, coronary artery disease, congestive heart failure, severe arrhythmia) that, in the opinion of the Investigator, would compromise the safety of the patient or compromise the ability of the patient to complete the study.
  • Symptomatic central nervous system metastases. Patients with asymptomatic brain metastases are allowed. The patient must be stable after radiotherapy for greater than or equal to 2 weeks and off corticosteroids for greater than or equal to 1 week.
  • History of interstitial lung disease or pulmonary fibrosis.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Incidence of cardiac toxicity

Secondary Outcome Measures

Outcome Measure
Progression free survival
Toxicity profile
Time to tumor progression
Duration of overall response
Objective tumor response rate according to RECIST criteria measured every 2 cycles (every 6 weeks)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Celgene Corporation

Investigators

  • Study Director: Richard S Ungerleider, MD, Theradex

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Completion

December 1, 2007

Study Registration Dates

First Submitted

September 26, 2006

First Submitted That Met QC Criteria

September 26, 2006

First Posted (Estimate)

September 27, 2006

Study Record Updates

Last Update Posted (Estimate)

September 23, 2008

Last Update Submitted That Met QC Criteria

September 22, 2008

Last Verified

September 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CNF3140-MBC-001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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