Clinical Trials

Text Size A A

E-Mail to a Friend






secret  Click to Play Audio


SCCA Breast Cancer Clinical Trials

Lapatinib vs Trastuzumab for HER2/Positive First-line Metastatic Cancer (UW09024)
A Randomized, Open-Label, Phase III Study of Taxane-Based Chemotherapy With Lapatinib (Tykerb) or Trastuzumab (Herceptin) as First-Line Therapy for Women With HER2/Neu Positive Metastatic Breast Cancer
Status Conditions Phase Study ID
Closed Breast Cancer Phase III UW09024
NCT00667251
Summary

RATIONALE: Drugs used in chemotherapy, such as paclitaxel and docetaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Lapatinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Monoclonal antibodies, such as trastuzumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. It is not yet known whether chemotherapy is more effective with lapatinib or trastuzumab in treating patients with breast cancer.

PURPOSE: This randomized phase III trial is studying chemotherapy and lapatinib to see how well they work compared with chemotherapy and trastuzumab in treating women with HER2/neu-positive metastatic breast cancer.


Investigator
Georgiana K. Ellis, MD
Location    
SCCA Breast Cancer Clinical Trials Program 800-804-8824 Refer Patient
Bozeman Deaconess Cancer Center, Bozeman, MT 406-585-5070  
Cascade Cancer Center, Kirkland WA 425-285-3928  
Multicare Health System, Tacoma WA 253-403-5265  
Olympic Medical Center, Sequim WA 360-683-9895  
Overlake Hospital Medical Center, Bellevue WA 425-688-5407  
Providence Alaska Medical Center, Anchorage AK 907-212-3109  
Skagit Valley Hospital, Mt. Vernon WA 360-424-2687  
Wenatchee Valley Medical Center, Wenatchee WA 509-665-5800 x5122  
Eligibility Criteria (must meet the following to participate in this study)
Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • Histologically confirmed adenocarcinoma of the breast

    • Metastatic (stage IV) disease at primary diagnosis or at relapse after curative intent therapy
  • HER2/neu* overexpressing and/or amplified disease in the invasive component of the primary or metastatic lesion as defined by the following:

    • 3+ overexpression (in > 30% of invasive tumor cells) by immunohistochemistry (IHC)
    • 2+ or 3+ overexpression (in ≤ 30% of invasive tumor cells) by IHC AND demonstrates HER2/neu gene amplification by fluorescence in situ hybridization (FISH)
    • HER2/neu gene amplification by FISH (> 6 HER2/neu gene copies per nucleus, or a FISH ratio [HER2 gene copies to chromosome 17 signals] of ≥ 2.2) NOTE: *Patients with a negative or equivocal overall result (FISH ratio of < 2.2, ≤ 6.0 HER2/neu gene copies per nucleus, or staining scores of 0, 1+, 2+, or 3+ [in ≤ 30% of neoplastic cells] by IHC) are not eligible
  • Formalin-fixed paraffin-embedded tumor specimen available
  • No CNS metastases (including leptomeningeal involvement)
  • Hormone receptor status not specified

PATIENT CHARACTERISTICS:

  • Menopausal status not specified
  • ECOG performance status 0-2
  • Life expectancy > 6 months
  • Absolute granulocyte count > 1,500/mm³
  • Platelet count > 75,000/mm³
  • Hemoglobin > 10 g/dL
  • Serum creatinine ≤ 2.0 times upper limit of normal (ULN)
  • Total bilirubin ≤ 1.5 times ULN (< 3 times ULN for patients with Gilbert's disease)
  • AST and/or ALT ≤ 2.5 times ULN (< 5 times ULN for patients planning to receive paclitaxel-based therapy)
  • LVEF ≥ 50% by MUGA or ECHO
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • Must be accessible for study treatment and follow-up
  • No history of other malignancies, except adequately treated ductal carcinoma in situ or lobular carcinoma in situ, adequately treated nonmelanoma skin cancer, curatively treated carcinoma in situ of the cervix, or other curatively treated solid tumor (non-breast) with no evidence of disease for ≥ 5 years
  • No serious cardiac illness or condition including, but not limited to, any of the following:

    • History of documented congestive heart failure or systolic dysfunction (LVEF < 50%)
    • High-risk uncontrolled arrhythmias (i.e., ventricular tachycardia, high-grade atrioventricular block, or supraventricular arrhythmias that are not adequately rate-controlled)
    • Unstable angina pectoris requiring anti-anginal medication
    • Clinically significant valvular heart disease
    • Evidence of transmural infarction on ECG
    • Inadequately controlled hypertension (i.e., systolic blood pressure [BP] > 180 mm Hg or diastolic BP > 100 mm Hg)
    • New York Heart Association class III-IV functional status
  • No serious illness or medical condition that would not allow the patient to be managed according to the protocol including, but not limited to, any of the following:

    • History of significant neurologic or psychiatric disorder that would impair the ability to obtain informed consent or limit compliance with study requirements
    • Active uncontrolled infection
    • Serious or nonhealing wound, ulcer, or bone fracture
  • No peripheral neuropathy ≥ grade 2
  • No gastrointestinal (GI) tract disease resulting in an inability to take oral medication including, but not limited to, any of the following:

    • Malabsorption syndrome
    • Requirement for IV alimentation
    • Uncontrolled inflammatory GI disease (e.g., Crohn's disease or ulcerative colitis)
  • No history of allergic or hypersensitivity reactions to any study drug or their excipients or to compounds with similar chemical composition to any of the study drugs

    • Prior allergic reactions to taxanes are allowed provided they were adequately treated and, according to the treating physician, would not prohibit further treatment with taxanes
Last Updated
October 13, 2011
See this trial at ClinicalTrials.gov
Access protocol and consent forms at Fred Hutchinson Cancer Research Center
Disclaimer: We update this information regularly. However, what you read today may not be completely up to date.

Please remember:
  • Talk to your health care providers first before making decisions about your health care.
  • Whether you are eligible for a research study depends on many things. There are specific requirements to be in research studies. These requirements are different for each study.