(EGF 108919) 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

Trial DescriptionPurpose: 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.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.Eligibility: Eligibility criteria include the following:

• At least 18 years old
• No CNS metastases
• No previous surgery to remove all or part of the stomach or small intestine
• For more information about the eligibility criteria for this trial, refer to the Health Professional version.

Final eligibility for a clinical trial is determined by the health professionals conducting the trial.Treatment/Intervention: Patients will be randomly assigned (have an equal chance of being placed) to one of two treatment groups.Some patients in group one will receive an infusion of paclitaxel once a week for 3 weeks. Treatment may repeat every 4 weeks for up to six courses. Other patients will receive an infusion of docetaxel every 3 weeks for up to eight courses; these patients may also receive G-CSF. All patients will also receive lapatinib by mouth once a day for as long as benefit is shown.Some patients in group two will receive an infusion of paclitaxel once a week for 3 weeks and an infusion of trastuzumab once a week for 4 weeks. Treatment may repeat every 4 weeks for up to six courses. Other patients will receive infusions of docetaxel and trastuzumab every 3 weeks for up to eight courses. After finishing chemotherapy and trastuzumab, all patients will receive an infusion of trastuzumab alone every 3 weeks for as long as benefit is shown.Previously collected tissue samples will be studied in the laboratory.Patients will fill out quality of life questionnaires periodically. After finishing treatment, they will be evaluated at 4 weeks and then periodically thereafter.Important:For more details about this trial, refer to the Health Professional version of the trial summary.If you are interested in participating in a clinical trial, contact your doctor for a referral or call a trial contact person listed below. You may see the same contact person listed at more than one site, however, if you call the number listed you can ask to speak to the study coordinator or person involved with the specific trial you are interested in. If you have questions about cancer or clinical trials, call the Cancer Information Service at 1-800-4-CANCER (1-800-422-6237). General information about clinical trials, including risks, benefits, and costs, can be found on NCI's Web site. Trial Contact Information Trial Lead OrganizationsNCIC-Clinical Trials Group