This trial is active, not recruiting.

Conditions breast cancer, metastases
Phase phase 4
Sponsor Genentech
Start date November 2000
End date September 2004
Trial size 1000 participants
Trial identifier NCT00097487, H2251n


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.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Observational model defined population
Time perspective longitudinal

Eligibility Criteria

Female participants at least 18 years old.

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

Additional Information

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
Trial information was received from ClinicalTrials.gov and was last updated in June 2005.
Information provided to ClinicalTrials.gov by Genentech.