NCT00429299

Neoadjuvant Study With Chemotherapy, Lapatinib And Trastuzumab In Breast Cancer

Chemotherapy Plus Lapatinib or Trastuzumab or Both in Her2+ Primary Breast Cancer. A Randomized Phase IIb Study With Biomarker Evaluation.

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 121 (actual)
• Sponsor: GlaxoSmithKline · Industry
• Sex: Female
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

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

Conditions

• Neoplasms, Breast

Interventions

Type	Name	Description
DRUG	lapatinib	Arm B 1250mg/d PO Arm C 750mg/d PO
BIOLOGICAL	trastuzumab	First dose 4mg/kg in 60mins, then weekly 2mg/kg in 30 mins
DRUG	paclitaxel	80mg/sqm 1 hour infusion for 12 weeks
DRUG	fluorouracil	600mg/sqm iv day 1 q21 days for four coursess
DRUG	epidoxorubicin	75mg/sqm iv day 1 q21 days for four courses
DRUG	cyclophosphamide	600mg/sqm day 1 q21 days for four courses

Timeline

• Start date: 2006-08-01
• Primary completion: 2012-06-01
• Completion: 2012-06-01
• First posted: 2007-01-31
• Last updated: 2016-03-22
• Results posted: 2016-03-22

Locations

17 sites across 3 countries: Germany, Italy, Poland