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Sponsors and Collaborators: |
National Cancer Institute of Canada GlaxoSmithKline |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00667251 |
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.
Condition | Intervention | Phase |
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Breast Cancer |
Biological: trastuzumab Drug: lapatinib ditosylate |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label |
Official Title: | A Randomized, Open-Label, Phase III Study of Taxane Based Chemotherapy With Lapatinib or Trastuzumab as First-Line Therapy for Women With HER2/Neu Positive Metastatic Breast Cancer |
Estimated Enrollment: | 600 |
Study Start Date: | July 2008 |
Estimated Primary Completion Date: | July 2011 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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Arm I: Experimental
Patients receive either paclitaxel IV on days 1, 8, and 15 OR docetaxel IV on day 1. Treatment with paclitaxel repeats every 4 weeks for 6 courses and treatment with docetaxel repeats every 3 weeks for 8 courses in the absence of disease progression or unacceptable toxicity. Patients also receive oral lapatinib ditosylate once daily in the absence of disease progression or unacceptable toxicity.
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Drug: lapatinib ditosylate
Given orally
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Arm II: Active Comparator
Patients receive paclitaxel IV on days 1, 8, and 15 and trastuzumab (Herceptin®) IV on days 1, 8, 15, and 22. Treatment repeats every 4 weeks for 6 courses in the absence of disease progression or unacceptable toxicity. Alternatively, patients may receive docetaxel IV and trastuzumab IV on day 1. Treatment repeats every 3 weeks for 8 courses in the absence of disease progression or unacceptable toxicity. After completion of taxane chemotherapy and trastuzumab, all patients receive trastuzumab alone IV once every 3 weeks in the absence of disease progression or unacceptable toxicity. |
Biological: trastuzumab
Given IV
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OBJECTIVES:
Primary
Secondary
OUTLINE: This is a multicenter study. Patients are stratified according to prior neoadjuvant/adjuvant anti-HER2/neu-targeted therapy (yes vs no), prior neoadjuvant/adjuvant taxane chemotherapy (yes vs no), planned taxane therapy (paclitaxel vs docetaxel), and liver metastasis (yes vs no). Patients are randomized to 1 of 2 treatment arms.
Patients complete quality of life questionnaires (EORTC QLQ-C30 and a Trial Specific Checklist) at baseline, every 12 weeks for 96 weeks, and then every 24 weeks until disease progression.
After completion of study treatment, patients are followed at 4 weeks, 12 weeks, and then every 12 weeks thereafter.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed adenocarcinoma of the breast
HER2/neu* overexpressing and/or amplified disease in the invasive component of the primary or metastatic lesion as defined by the following:
PATIENT CHARACTERISTICS:
No serious cardiac illness or condition including, but not limited to, any of the following:
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:
No gastrointestinal (GI) tract disease resulting in an inability to take oral medication including, but not limited to, any of the following:
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 CONCURRENT THERAPY:
At least 2 weeks since prior radiotherapy in the adjuvant or metastatic setting
Study Chair: | Karen A. Gelmon, MD | British Columbia Cancer Agency |
Study Chair: | Karen A. Gelmon, MD | British Columbia Cancer Agency |
Study ID Numbers: | CDR0000594764, CAN-NCIC-MA31, GSK-EGF108919, EUDRACT-2007-004568-27 |
Study First Received: | April 25, 2008 |
Last Updated: | April 30, 2009 |
ClinicalTrials.gov Identifier: | NCT00667251 History of Changes |
Health Authority: | Unspecified |
stage IV breast cancer recurrent breast cancer HER2-positive breast cancer |
Skin Diseases Trastuzumab Breast Neoplasms Lapatinib |
Protein Kinase Inhibitors Taxane Breast Diseases Recurrence |
Skin Diseases Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Breast Neoplasms Lapatinib Enzyme Inhibitors Protein Kinase Inhibitors |
Pharmacologic Actions Neoplasms Neoplasms by Site Therapeutic Uses Trastuzumab Breast Diseases |