A Randomized, Open-Label, Phase III Study of Taxane Based Chemotherapy With Lapatinib or Trastuzumab as First-Line Therapy for Women With Human Epidermal Growth Factor Receptor 2 (HER2)/Neu Positive Metastatic Breast Cancer

Phase 3

Completed

• Conditions: Human Epidermal Growth Factor Receptor 2 (HER2)/Neu positive metastatic breast cancer; Cancer - Breast

• Registration Number: ACTRN12609000143224
• Lead Sponsor: GlaxoSmithkline

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2009-03-06
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Completed
• Sex: Female
• Target Recruitment: 600

Inclusion Criteria

Histologically confirmed adenocarcinoma of the breast.
Metastatic breast cancer (stage IV) at primary diagnosis or at relapse after curative intent therapy.
HER2/neu overexpressing and/or amplified disease in the invasive component of the primary or metastatic lesion.
Formalin fixed paraffin embedded tumour specimen available for central testing.
Patients must have evidence of metastatic disease but measurable disease in not mandatory.
life expectancy must be >6 months.

Exclusion Criteria

History of othermalignancies except, adequately treated ductal carcinoma in situ (DCIS0, non-melanoma skin cancer, curatively treated in-situ cancer of the cervix, or other solid tumours (non-breast) curatively treated with no evidence of disease for >= 5yrs.
Patients who have received prior chemotherapy, immunotherapy, biologic therapy or HER2/neu targeted therapy for recurrent or metastatic breast cancer.
patients wiht CNS metastases.
Patients with serious cardiac illness or condition.
Patients receiving ongoing anticancer treatment or other investigational anti-cancer agents for breast cancer.
Pregnant or lactating women.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The primary outcome is progression-free survival. This is defined as the time interval between the date of randomization and the date of disease progresson or death from any cause, whichever comes first. Radiological evaluations for tumour measurements (radiology testing) and clinical evaluation (monitoring by the medical oncologist) will be performed to determine the outcome for each patient.[3-monthly until time of first progression of the condition (ie. HER2/Neu positive metastatic breast cancer in women)]