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

Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00097487
• Other study ID #: H2251n
• Status: Completed
• Phase: N/A
• First received: November 24, 2004
• Last updated: February 28, 2018
• Start date: November 30, 2000
• Est. completion date: September 30, 2004

Study information

• Verified date: February 2018
• Source: Genentech, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1000
• Est. completion date: September 30, 2004
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms
• Metastases

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Genentech, Inc.