ErbB2 Positive Metastatic Breast Cancer

Sponsor
China Medical University Hospital
Study ID
NCT01658358
Phase
PHASE1/PHASE2
Status
Terminated

Conditions

Eligibility Criteria

Sex
FEMALE
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • Lapatinib — DRUG
    * dose level I, II 1000mg po daily * dose level III, IV 1250mg po daily
  • Lipo-Dox — DRUG
    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,

Study Details

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

Key Dates

Start date
Jul 31, 2012
Status verified
Feb 2013
Primary completion
Sep 30, 2014
Completion
Sep 30, 2014

Study Design

Enrollment
15 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Phase I part :Systemic Therapy
    * Drug: Lapatinib * Drug: Lipo-Dox
  • Experimental: Phase II part
    * Drug: Lapatinib * Drug: Lipo-Dox Patients will receive recommended dose according to phase I study result. at least 8 cycles, then, with continue combination treatment cycles or single lapatinib treatment (start with 1500 mg per day) at investigator's discretion.

Primary Outcome Measure

Phase I part recommended dose of the combination of lapatinib with Lipo-Dox [ Time Frame: Phase I: 6 months ]

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