Clinical Research Details
Title:
Randomized Phase III Trial of Paclitaxel Combined with Trastuzumab, Lapatinib or Both as Neoadjuvant Treatment of HER2-positive Primary Breast Cancer
Purpose:
The purpose of this study is to determine if the pathologic complete response (pCR) in the breast to neoadjuvant weekly paclitaxel with trastuzumab plus lapatinib or to neoadjuvant weekly paclitaxel plus lapatinib (THL) is 20 percent greater than the pCR to weekly paclitaxel with trastuzumab alone (TH) in HER2-positive operable breast cancer.
Study Number:
202144091609
Number of Patients:
400
Elgibility:
Participants must be 18 years of age or older with stage II-III operable invasive HER2-positive breast cancer.
Treatment:
The participant will be randomly assigned to one of three treatment groups. Group 1 will receive paclitaxel and trastuzumab through a vein every week as well as take lapatinib by mouth daily for 16 weeks. Group 2 will receive paclitaxel and trastuzumab through a vein every week for 16 weeks. Group 3 will receive paclitaxel through a vein every week as well as take lapatinib by mouth daily for 16 weeks.
Principal Investigator:
Enrollment Phone:
(708) 327-3222