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ErbB2 Positive Metastatic Breast Cancer

NCT01658358 · Status: TERMINATED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 15

Last updated 2013-02-27

No results posted yet for this study

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

Conditions

Interventions

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,

Sponsors & Collaborators

  • China Medical University Hospital

    lead OTHER

Principal Investigators

  • Chang-Fang Chiu, PhD · China Medical University Hospital

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-07-31
Primary Completion
2014-09-30
Completion
2014-09-30

Countries

  • Taiwan

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01658358 on ClinicalTrials.gov