EUCTR2010-019390-15-IE
Active, not recruiting
Not Applicable
A Phase II, Randomized, Open-label Study of Lapatinib Plus Chemotherapy versus Trastuzumab Plus Chemotherapy as Firstline Treatment for Women with HER2-positive and p95HER2-positive Metastatic Breast Cancer - n/a
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- GlaxoSmithKline Research & Development Ltd
- Enrollment
- 300
- Status
- Active, not recruiting
- Last Updated
- 14 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\. Female \=18 years of age
- •2\. Histologically or cytologically confirmed invasive breast cancer with distant metastasis(ses) (designated as Stage IV or metastatic breast cancer)
- •Diagnosis with Stage IV or metastatic disease at either primary diagnosis or
- •3\. Not received prior systemic or local treatment (e.g., chemotherapy, endocrine or
- •radiotherapy) for Stage IV/metastatic breast cancer
- •Prior adjuvant and/or neo\-adjuvant therapy is permitted
- •4\. Documentation of HER2 overexpression or gene amplification, in the invasive
- •component of either a metastatic disease site or primary tumor, defined as:
- •3\+ by IHC
- •HER2/neu gene amplification by fluorescence, chromogenic or silver in
Exclusion Criteria
- •History of other malignancy.
- •Exception: Subjects who have been disease\-free for 5 years or subjects with a history of completely resected non\-melanoma skin cancer (basal or squamous) are eligible
- •2\. Concurrent anti\-cancer treatment or concurrent treatment with an investigational
- •3\. Administration of an investigational drug within 30 days or 5 half\-lives, whichever is longer, preceding the first dose of study treatment
- •4\. Prior treatment with anti\-HER2 therapy, except trastuzumab or lapatinib (time from
- •last dose of trastuzumab or lapatinib to randomization must be \=3 months)
- •5\. Serious cardiac illness or medical condition including but not confined to:
- •Uncontrolled arrhythmias
- •Uncontrolled or symptomatic angina
- •History of congestive heart failure (CHF)
Outcomes
Primary Outcomes
Not specified
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