Advanced or metastatic breast cancer
Conditions
Interventions
Product Name: GW572016
Product Code: GW572016
Pharmaceutical Form: Coated tablet
Pharmaceutical form of the placebo: Coated tablet
Route of administration of the placebo: Oral use
Trade Name: Taxol
P
Sponsors
GlaxoSmithKline R&D Ltd
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Able to give signed informed consent - Histologically confirmed invasive breast cancer - Tumours either untested or negative for ErbB2 overexpression - Female aged >=18 years - Of non-childbearing potential, or if of childbearing potential then with negative serum pregnancy test at screening and agreement to follow protocol-defined methods of birth control - ECOG performance status of 0 or 1 - Measurable disease according to RECIST - Tumour tissue to be available to retrospectively compare tumour response with intra-tumoural expression of biomarkers - Prior neodjuvant or adjuvant treatment with an anthracycline- or anthracenedione-containing regimen is permitted as long as cumulative dose of named drugs has not been exceeded, and patient has recovered from all toxicities - Prior taxane as part of a neoadjuvant or adjuvant therapy is permitted as long as disease progression was >6 months after completion of this treatment - Radiotherapy prior to initiation of randomised treatment other than the sole site of measurable/assessable disease is allowed - Patients must not have >=Grade 2 peripheral neuropathy - Able to swallow and retain oral medication - Cardiac function must be within the normal range - Patients must complete all screening assessments Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: - Pregnant or lactating - Received prior therapy for locally advanced or metastatic disease, or prior therapy with an ErbB1 and/or ErbB2 inhibitor in any setting - Bisphosphonate therapy for bone metastases initiated prior to start of randomised therapy is permitted; prophylactic bisphosphonates without bone disease are not permitted - Other malignancy unless disease-free for 5 years - Malabsorption syndrome, disease significantly affecting GI function, or resection of the stomach or small bowel - Any concurrent condiction that would make study participation inappropriate, or any serious medical condition that might interefere with safety - Unresolved or unstable, serious toxicity from a prior investigational drug - Active or uncontrolled infection - Condition that prohibits understanding or rendering of informed consent - History of uncontrolled or symptomatic angina, arrythmias, or CHF - CNS metastases or leptomeningeal carcinomatosis - Concurrent anti-cancer therapy other than paclitaxel - Concurrent investigational agent or participation in another clinical trial - Prior investigational drug within 30 days or 5 half-lives (whichever is longer) of first dose of randomised therapy - Hypersensitivity or idiosyncrasy to drugs chemically related to GW572016 (or placebo), or excipients - Hypersensitivity to paclitaxel or its excipients.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To compare the efficacy of the two study treatment groups;Secondary Objective: To compare the two study treatment groups with respect to:- - Tumour response rate, clinical benefit, time to response, duration of response, 6-months progression-free survival, overall survival - Toxicities due to treatment - Baseline and on-treatment serum ErbB1 and ErbB2 - Intra-tumoural expression of ErbB1, ErbB2 and other biomarkers - Quality of life.;Primary end point(s): Time to progression (TTP), defined as the interval between the date of randomisation and the earliest date of disease progression or death due to breast cancer (if sooner). | — |
Countries
Austria
Outcome results
None listed