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

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT00097487

Enrollment

1000

Registered

2004-11-25

Start date

2000-11-30

Completion date

2004-09-30

Last updated

2018-03-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Cancer, Metastases

Keywords

Metastatic Breast Cancer

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.

Interventions

None listed

Study design

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to No maximum

Healthy volunteers

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

Outcome results