None listed
Conditions
Interventions
1500 mg GW572016 Type of group
GW572016 administered orally in doses of 1500 mg once a day
Group name:1000 mg GW572016 Type of group
GW572016 administered orally in doses of 500 mg twice a day
Sponsors
GLAXOSMITHKLINE PERU S.A.,
Eligibility
Inclusion criteria
Inclusion criteria: Histologically confirmed invasive breast cancer with incurable stage IIIB, IIIC with T4 lesion or stage IV disease at primary diagnosis or at relapse after curative intent surgery. Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1. Documented amplification of ErbB2 by Fluorescence in situ hybridization (FISH) Measurable disease by Response Evaluation Criteria In Solid Tumors (RECIST) Adequate renal, hepatic and cardiac function
Exclusion criteria
Exclusion criteria: Prior chemotherapy, immunotherapy, biologic therapy or anti-ErbB1/ErbB2 therapy other than adjuvant therapy. [Prior neo-adjuvant or adjuvant therapy (including trastuzumab) will be allowed provided it was stopped at least 12 months before study entry. Patients with active brain metastases Patients with bilateral breast cancer, bone metastases as the only disease site or metastases to more than 30% of the hepatic parenchyma.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Outcome name:Number of Participants With a Best Overall Response (OR) of Confirmed Complete Response (CR) or Partial Response (PR). Measure:Number of Participants With a Best Overall Response (OR) of Confirmed Complete Response (CR) or Partial Response (PR). Timepoints:From the date of the first dose of investigational product to the first documented evidence of a confirmed CR or PR | — |
Secondary
| Measure | Time frame |
|---|---|
| Outcome name:Percentage of Participants With Clinical Benefit Measure:Percentage of Participants With Clinical Benefit (CR or PR or Stable Disease [SD] for at Least 24 Weeks), as Assessed by the IRC and Investigator Timepoints:From the date of the first dose of investigational product until the date of disease progression or death due to breast cancer | — |
Countries
Chile, India, Malasya, Mexico, Pakistan, Peru, Poland, Singapore, Taiwan, United States
Contacts
Public ContactSarita Mattos
GLAXOSMITHKLINE PERU S.A.
Outcome results
None listed