Clinical Research Details
Title:
A Randomised, Multi-Centre, Open-Label, Phase III Study of Adjuvant Lapatinib, Trastuzumab Their Sequence and Their Combination in Patients With HER2/ErbB2 Positive Primary Breast Cancer
Purpose:
To compare disease-free survival and overall survival in participants with HER2 overexpressing and/or amplified breast cancer randomized to trastuzumab for one year versus lapatinib for one year versus weekly trastuzumab (12 weeks) followed by a six-week treatment-free interval followed by lapatinib (34 weeks) versus trastuzumab in combination with lapatinib for one year. To evaluate the safety and tolerability of all four treatment groups.
Study Number:
200914
Number of Patients:
8000
Elgibility:
Participants must be 18 years of age or older with primary breast cancer who have had surgery to remove the tumor. Participants must also have received at least four cycles of anthracycline-based (neo-) adjuvant chemotherapy regimen. The participant must have a tumor with over expression and/or amplification of HER2 in the invasive component of the primary tumor.
Treatment:
Participants will receive one of the following: trastuzumab alone, lapatinib alone, lapatinib in combination with trastuzumab or trastuzumab followed by a six-week break, followed by lapatinib. Lapatinib is given orally once daily in tablet form. Trastuzumab is given intravenously (IV) either weekly or every three weeks. Participants will also be given a chemotherapy drug called a taxane along with the study treatments during the first 12 weeks.
Principal Investigator:
Enrollment Phone:
(708) 327-3222