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

Metastatic Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT00380835
• Other study ID #: CNF3140-MBC-001
• Status: Withdrawn
• Phase: Phase 2
• First received: September 26, 2006
• Last updated: September 22, 2008
• Est. completion date: December 2007

Study information

• Verified date: September 2008
• Source: Celgene
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 66
• Est. completion date: December 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Breast Neoplasms
• Metastatic Breast Cancer

Intervention

Drug:
• Amrubicin

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Celgene Corporation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of cardiac toxicity
Secondary	Objective tumor response rate according to RECIST criteria measured every 2 cycles (every 6 weeks)
Secondary	Duration of overall response
Secondary	Time to tumor progression
Secondary	Progression free survival
Secondary	Toxicity profile