EUCTR2004-001905-93-GB
Active, not recruiting
Not Applicable
A Phase II study to evaluate the efficacy, safety and pharmacodynamics of lapatinib in combination with paclitaxel as neoadjuvant therapy in patients with newly diagnosed inflammatory breast cancer - Lapatinib combined with paclitaxel in newly diagnosed inflammatory breast cancer (IBC)
GlaxoSmithKline R&D Ltd0 sites60 target enrollmentJune 14, 2005
DrugsTaxol
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- ewly diagnosed infammatory breast cancer (IBC)
- Sponsor
- GlaxoSmithKline R&D Ltd
- Enrollment
- 60
- Status
- Active, not recruiting
- Last Updated
- 12 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •\- Histologically confirmed breast carcinoma with clinical diagnosis of IBC
- •\- Tumour that:\-
- •Cohort A \- overexpresses ErbB2 (defined IHC 2\+ or 3\+, or FISH\-positive) with or without expression of ErbB1 (by IHC), or
- •Cohort B \- expression of ErbB1 (defined as IHC \+) without overexpression of ErbB2\.
- •ErbB1 and ErbB2 status must be documented prior to dosing.
- •\- Tumour that is accessible for multiple biopsies
- •\- Male or female at least 18 years of age
- •\- Female patients must either be of non\-childbearing potential, or if of childbearing potential to have negative serum pregnancy test at screening and to agree to a protocol\-specified method of contraception during participation in the study
- •\- Able to swallow and retain oral medication
- •\- ECOG performance status 0\-2
Exclusion Criteria
- •\- Received prior biological, cytotoxic or hormonal therapy for breast cancer
- •\- Female who is pregnant or lactating
- •\- Patient who has malabsorption syndrome, disease affecting GI function, or resection of the stomach or small bowel
- •\- Considered medically unfit by the investigator
- •\- Has known hypersensitivity reaction or idiosyncrasy to drugs chemically\-related to the IMPs
- •\- Received treatment with any investigational drug in previous 4 weeks
- •\- Currently receiving amiodarone or within 6 months prior to screening
- •\- Currently receiving oral steroid treatment, or any other protocol\-specified prohibited medication. Use of cimetidine and/or steroids is permitted when required as standard treatment for paclitaxel administration.
- •\- Had major surgery within previous 2 weeks
- •\- Has condition/s which will not permit compliance with the protocol
Outcomes
Primary Outcomes
Not specified
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