drugset / Trial / NCT00429299

Neoadjuvant Study With Chemotherapy, Lapatinib And Trastuzumab In Breast Cancer

NCT00429299 ↗

Phase 2 Completed 121 enrolled GlaxoSmithKline
RandomizedParallel-groupOpen-labelTreatment

Summary

Evaluate the activity of Trastuzumab, Lapatinib, and a combination of both agents with chemotherapy in the preoperative (neoadjuvant) treatment of early breast cancer.

Timeline

Start
2006-08
Primary completion
2012-06
Completion
2012-06

Outcome

Met primary endpoint

paper the combination of lapatinib and trastuzumab plus chemotherapy increases the pathologic complete remission (pCR) rate compared with chemotherapy plus either trastuzumab or lapatinib. PMID 26245675 ↗

Publications

Drugs

EvaluationDrugModalityDoseRoute
Subject Lapatinib Small molecule 750 mg Oral
Subject Lapatinib Small molecule 1250 mg Oral
Comparator Trastuzumab Monoclonal antibody 2 mg/kg —
Background Cyclophosphamide Other / unclassified 600 mg/m2 —
Background Epirubicin Small molecule 75 mg/m2 Intravenous
Background Paclitaxel Small molecule 80 mg/m2 —
Background fluorouracil Small molecule 600 mg/m2 Intravenous

Indications