NCT00367471

Combination Of Lapatinib With Carboplatin, Paclitaxel, and With or Without Trastuzumab In Metastatic Breast Cancer.

A Phase I, Dose Escalation Study to Assess the Safety and Tolerability of Lapatinib in Combination With Carboplatin, Paclitaxel, With and Without Trastuzumab in Subjects With Metastatic Breast Cancer

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 31 (actual)
• Sponsor: Novartis Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to determine the optimally-tolerated regimens (OTR) for lapatinib in combination with paclitaxel, carboplatin with and without trastuzumab in patients with metastatic breast cancer.

Conditions

• Neoplasms, Breast

Interventions

Type	Name	Description
DRUG	lapatinib	Lapatinib (GW572016) is a potent small molecule, reversible inhibitor of both EGFR and ErbB2 tyrosine kinases
DRUG	carboplatin	An alkylating agent used in the treatment of some cancers
DRUG	trastuzumab	A monoclonal antibody that interferes with the HER2/neu receptor
DRUG	paclitaxel	A mitotic inhibitor used in cancer treatment

Timeline

• Start date: 2006-12-07
• Primary completion: 2010-12-22
• Completion: 2019-09-12
• First posted: 2006-08-23
• Last updated: 2020-09-09

Locations

3 sites across 1 country: United States

Regulatory

• FDA-regulated drug study