Lapatinib In Chemotherapy-Naive Or Metastatic Breast Cancer

GlaxoSmithKline (GSK)

Status and phase

Completed

Phase 2

Conditions

Neoplasms, Breast

Treatments

Drug: Lapatinib

Study type

Interventional

Funder types

Industry

Identifiers

NCT00089999

EGF20009

Details and patient eligibility

About

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 breast cancer.

Enrollment

138 patients

Sex

Female

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.