Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-25 @ 12:00 AM
Ignite Modification Date:
2025-12-25 @ 12:00 AM
NCT ID:
NCT01658358
Brief 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.
Study:
NCT01658358
Study Brief:
Protocol Section:
NCT01658358