NCT01658358

ErbB2 Positive Metastatic Breast Cancer

A Phase I/II Study of Lapatinib (Tykerb) Plus Liposomal Doxorubicin Hydrochloride ( Lipo-Dox) for Patients With ErbB2 Positive Metastatic Breast Cancer

• Status: Terminated
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 15 (estimated)
• Sponsor: China Medical University Hospital · Academic / Other
• Sex: Female
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

Objectives: Phase I part * Primary Objective: To determine the recommended dose of the combination of lapatinib with Lipo-Dox as first line chemotherapy in patients with ErbB2 positive metastatic breast cancer. * Secondary Objectives:To define the safety profile; To observe the response rate and progression free survival Phase II part * Primary Objective :To determined the objective response rate of the combination of lapatinib with Lipo-Dox as first line chemotherapy in patients with ErbB2 positive metastatic breast cancer. * Secondary Objectives:To define the safety profile; To determined the progression free survival

Detailed description

In phase I part Lapatinib (L) - dose level I, II 1000mg po daily dose level III, IV 1250mg po daily Intravenous Lipo Dox at the dose level reached on days 1 of a 21 days cycle• The recommended duration of combination treatment for each patient is at least 8 cycles, then, with continue combination treatment cycles or single lapatinib treatment (start with 1500 mg per day) at investigator's discretion. The treatment will stop if progressive disease, unacceptable toxicity or patient's refusal occurred. Intra patient escalation of dose level is allowed if no major toxicity noted. In phase II part Patients will receive recommended dose according to phase I study result. The recommended duration of combination treatment for each patient is at least 8 cycles, then, with continue combination treatment cycles or single lapatinib treatment (start with 1500 mg per day) at investigator's discretion. The treatment will stop if progressive disease, unacceptable toxicity or patient's refusal occurred. Intra patient escalation of dose level is allowed if no major toxicity noted.

Conditions

• Metastatic Breast Cancer

Interventions

Type	Name	Description
DRUG	Lapatinib	* dose level I, II 1000mg po daily * dose level III, IV 1250mg po daily
DRUG	Lipo-Dox	at the dose level reached on days 1 of a 21 days cycle. The recommended duration of combination treatment for each patient is at least 8 cycles,

Timeline

• Start date: 2012-07-01
• Primary completion: 2014-09-01
• Completion: 2014-09-01
• First posted: 2012-08-07
• Last updated: 2013-02-27

Locations

1 site across 1 country: Taiwan