A Study of Patients With HER2 Gene Amplified Metastatic Breast Cancer Treated With First Line Herceptin and a Taxane

The recruitment status of this study is unknown because the information has not been verified recently.

Verified November 2004 by Genentech.
Recruitment status was Active, not recruiting

Sponsor:

Information provided by:

Genentech

ClinicalTrials.gov Identifier:

NCT00097487

First received: November 24, 2004

Last updated: June 23, 2005

Last verified: November 2004

History of Changes

Tracking Information
First Received Date ^ICMJE	November 24, 2004
Last Updated Date	June 23, 2005
Start Date ^ICMJE	November 2000
Primary Completion Date	Not Provided
Current Primary Outcome Measures ^ICMJE	Not Provided
Original Primary Outcome Measures ^ICMJE	Not Provided
Change History	Complete list of historical versions of study NCT00097487 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE	Not Provided
Original Secondary Outcome Measures ^ICMJE	Not Provided
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	A Study of Patients With HER2 Gene Amplified Metastatic Breast Cancer Treated With First Line Herceptin and a Taxane
Official Title ^ICMJE	Clinical Outcomes in Patients With HER2 Gene-Amplified Metastatic Breast Cancer Treated With First Line Herceptin in Combination With a Taxane: A Phase IV, Prospective, Community Based Study
Brief Summary	This study is a Phase IV, prospective, nonrandomized, community-based study of clinical outcomes in patients with metastatic breast cancer treated with Herceptin and a taxane.
Detailed Description	Not Provided
Study Type ^ICMJE	Observational
Study Design ^ICMJE	Observational Model: Defined Population Observational Model: Natural History Time Perspective: Longitudinal Time Perspective: Prospective
Target Follow-Up Duration	Not Provided
Biospecimen	Not Provided
Sampling Method	Not Provided
Study Population	Not Provided
Condition ^ICMJE	Breast Cancer Metastases
Intervention ^ICMJE	Not Provided
Study Group/Cohort (s)	Not Provided
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Active, not recruiting
Enrollment ^ICMJE	1000
Completion Date	September 2004
Primary Completion Date	Not Provided
Eligibility Criteria ^ICMJE	Inclusion Criteria: Signed informed consent Available tissue for central laboratory evaluation of HER2 status Histologically confirmed, measurable or nonmeasurable but evaluable, HER2 positive metastatic breast cancer (HER2 positive is defined as 3+ staining by IHC or gene amplification by FISH, determined by the local or central laboratory) Life expectancy >6 months Female, age >=18 years ECOG performance status of 0, 1, or 2 Adequate bone marrow function as indicated by the following: ANC >1500/uL, Platelet count >=100,000/uL Adequate renal function, as indicated by creatinine <=1.5× upper limit of normal (ULN) Adequate liver function, as indicated by bilirubin <=1.5× ULN and AST or ALT <2× ULN unless related to primary disease Use of an adequate means of birth control (women of childbearing potential) Exclusion Criteria: Initiation of Herceptin >=4 weeks after beginning taxane chemotherapy Prior chemotherapy for metastatic disease Prior cumulative anthracycline dose of >360 mg/m2 History of significant cardiac disease or uncontrolled arrhythmias Ejection fraction of <50% or below the lower limit of normal Active infection Symptomatic or untreated brain metastases Pregnancy or lactation Concomitant malignancies or previous malignancies within the last 5 years, with the exception of adequately treated basal or squamous cell carcinoma of the skin or carcinoma in situ of the cervix Symptomatic intrinsic lung disease or extensive tumor involvement of the lungs, resulting in dyspnea at rest Hypersensitivity to study medications Major organ failure or systemic disease precluding the safe administration of study medications
Gender	Female
Ages	18 Years and older
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	Not Provided

Administrative Information
NCT Number ^ICMJE	NCT00097487
Other Study ID Numbers ^ICMJE	H2251n
Has Data Monitoring Committee	Not Provided
Responsible Party	Not Provided
Study Sponsor ^ICMJE	Genentech
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	Genentech
Verification Date	November 2004
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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