Ignite Creation Date:
2025-12-25 @ 12:00 AM
Ignite Modification Date:
2026-01-13 @ 3:23 AM
Study NCT ID:
NCT01658358
Status:
TERMINATED
Last Update Posted:
2013-02-27
First Post:
2012-08-01
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
ErbB2 Positive Metastatic Breast Cancer
Sponsor:
China Medical University Hospital
Organization:
Study Overview
Official Title:
A Phase I/II Study of Lapatinib (Tykerb) Plus Liposomal Doxorubicin Hydrochloride ( Lipo-Dox) for Patients With ErbB2 Positive Metastatic Breast Cancer
Status:
TERMINATED
Status Verified Date:
2013-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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.
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: