Clinical trial NCT00380835: Study of Amrubicin With or Without Herceptin in Patients With Metastatic Breast Cancer
Official title: A Phase 2 Trial of Amrubicin With or Without Herceptin in the Treatment of Metastatic Breast Cancer
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE2
Conditions: Metastatic Breast Cancer
Keywords: metastatic breast cancer
amrubicin
Lead sponsor: Celgene
Sponsor class: INDUSTRY
First posted: 2006-09-27
Enrollment: 66
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


Eligibility criteria: 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.

Primary outcomes:
measure: Incidence of cardiac toxicity
Secondary outcomes:
measure: Objective tumor response rate according to RECIST criteria measured every 2 cycles (every 6 weeks)
measure: Duration of overall response
measure: Time to tumor progression
measure: Progression free survival
measure: Toxicity profile
Other outcomes:
Locations:
city: New Milford
country: United States
state: Connecticut
city: Sharon
country: United States
state: Connecticut
city: Torrington
country: United States
state: Connecticut
city: Burnsville
country: United States
state: Minnesota
city: Edina
country: United States
state: Minnesota
city: Maplewood
country: United States
state: Minnesota
city: Minneapolis
country: United States
state: Minnesota
city: St. Paul
country: United States
state: Minnesota
city: Woodbury
country: United States
state: Minnesota
city: Columbia
country: United States
state: Missouri
city: Albany
country: United States
state: New York
city: Amsterdam
country: United States
state: New York
city: Hudson
country: United States
state: New York
city: Latham
country: United States
state: New York
city: Rexford
country: United States
state: New York
city: Schenectady
country: United States
state: New York
city: Troy
country: United States
state: New York
city: Asheville
country: United States
state: North Carolina
city: Dallas
country: United States
state: Texas
city: Dallas
country: United States
state: Texas
city: Dallas
country: United States
state: Texas
city: El Paso
country: United States
state: Texas
city: El Paso
country: United States
state: Texas
city: Houston
country: United States
state: Texas
city: Midland
country: United States
state: Texas
city: Odessa
country: United States
state: Texas
city: Plano
country: United States
state: Texas
city: Tyler
country: United States
state: Texas
Study officials:
affiliation: Theradex
name: Richard S Ungerleider, MD
role: STUDY_DIRECTOR
References: