Status:
COMPLETED
Lapatinib In Chemotherapy-Naive Or Metastatic Breast Cancer
Lead Sponsor:
GlaxoSmithKline
Conditions:
Neoplasms, Breast
Eligibility:
FEMALE
18+ years
Phase:
PHASE2
Brief Summary
This phase II study will evaluate and compare the efficacy and tolerability of two dose schedules (1500 mg QD and 500 mg BID) of oral Lapatinib as treatment for patients with advanced or metastatic br...
Eligibility Criteria
Inclusion
- 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:
- 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.
Exclusion
Key Trial Info
Start Date :
June 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2008
Estimated Enrollment :
138 Patients enrolled
Trial Details
Trial ID
NCT00089999
Start Date
June 1 2004
End Date
March 1 2008
Last Update
February 28 2017
Active Locations (31)
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1
GSK Investigational Site
Hollywood, Florida, United States, 33021
2
GSK Investigational Site
Santiago, Región Metro de Santiago, Chile, 7500921
3
GSK Investigational Site
Santiago, Región Metro de Santiago, Chile, 8380456
4
GSK Investigational Site
Santiago, Región Metro de Santiago, Chile