Paclitaxel + Trastuzumab +/- Lapatinib for Breast Cancer

Recruiting in Palo Alto (17 mi)

+364 other locations

Overseen byLisa A Carey

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Waitlist Available

Sponsor: National Cancer Institute (NCI)

No Placebo Group

Pivotal Trial (Near Approval)

Prior Safety Data

Trial Summary

What is the purpose of this trial?

This randomized phase III trial studies paclitaxel and trastuzumab with or without lapatinib to see how well they work in treating patients with stage II or stage III breast cancer that can be removed by surgery. Drugs used in chemotherapy, such as paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. 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. Lapatinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving paclitaxel with trastuzumab and/or lapatinib before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed. It is not yet known which regimen is more effective in treating patients with breast cancer.

Research Team

Lisa A Carey

Principal Investigator

Alliance for Clinical Trials in Oncology

Eligibility Criteria

This trial is for patients with stage II or III breast cancer that can be surgically removed. Participants must not have metastatic disease, should have normal liver function and heart health, know their hormone receptor status, agree to provide biopsies, and not be pregnant or breastfeeding. Prior treatments for this cancer are disallowed. Tumors must be HER2 positive.

Inclusion Criteria

My cancer is at stage III and has been checked for spread.

My tumor is HER2 positive, confirmed by specific tests.

I haven't received any treatment for this cancer.

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Treatment Details

Interventions

Lapatinib Ditosylate (Small Molecule Kinase Inhibitor)
Paclitaxel (Taxane)
Trastuzumab (Monoclonal Antibodies)

Trial OverviewThe study tests the effectiveness of paclitaxel and trastuzumab with or without lapatinib before surgery in shrinking tumors. Paclitaxel is a chemotherapy drug; trastuzumab is a monoclonal antibody blocking tumor growth; lapatinib inhibits enzymes needed by tumor cells.

Participant Groups

3Treatment groups

Experimental Treatment

Active Control

Group I: Arm III (TL)Experimental Treatment2 Interventions

Patients receive paclitaxel 80 mg/m\^2 IV over 1 hour once weekly and lapatinib ditosylate 15000 mg PO once daily for 16 weeks in the absence of disease progression or unacceptable toxicity. (Discontinued as of 6-15-11)

Group II: Arm I (THL)Experimental Treatment4 Interventions

Patients receive trastuzumab 2 mg/kg IV over 30-90 minutes and paclitaxel 80 mg/m\^2 IV over 1 hour once weekly and lapatinib ditosylate 750 mg PO once daily for 16 weeks in the absence of disease progression or unacceptable toxicity.

Group III: Arm II (TH)Active Control3 Interventions

Patients receive trastuzumab 2 mg/kg IV over 30-90 minutes and paclitaxel 80 mg/m\^2 IV over 1 hour once weekly for 16 weeks in the absence of disease progression or unacceptable toxicity.

Paclitaxel is already approved in Canada for the following indications: