Lapatinib In Chemotherapy-Naive Or Metastatic Breast Cancer

Completed · Phase 2

Conditions studied: Neoplasms, Breast

In brief

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.

Key facts

Study ID

NCT00089999

Run by

GlaxoSmithKline

People needed

138

Starts

2004-06-01

Expected to finish

2008-03-01

Last updated by the study team

2017-02-28

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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.

Where it is running

• GSK Investigational Site — Hollywood, Florida, United States
• GSK Investigational Site — Santiago, Región Metro de Santiago, Chile
• GSK Investigational Site — Santiago, Región Metro de Santiago, Chile
• GSK Investigational Site — Santiago, Región Metro de Santiago, Chile
• GSK Investigational Site — Pokfulam, Hong Kong
• GSK Investigational Site — Delhi, India
• GSK Investigational Site — Hyderabad, Andhra Pradesh, India
• GSK Investigational Site — Pune, India
• GSK Investigational Site — Bandar Tun Razak, Cheras, Malaysia
• GSK Investigational Site — Kubang Kerian, Malaysia
• GSK Investigational Site — Tanjong Bungah, Malaysia
• GSK Investigational Site — Tanjong Bungah, Malaysia
• GSK Investigational Site — Ixtaltepec / Espinal, Oaxaca, Mexico
• GSK Investigational Site — Mérida, Yucatán, Mexico
• GSK Investigational Site — México, Mexico
• GSK Investigational Site — Karachi, Pakistan
• GSK Investigational Site — Karachi, Pakistan
• GSK Investigational Site — Karachi, Pakistan
• GSK Investigational Site — Lahore, Pakistan
• GSK Investigational Site — Rawalpindi, Pakistan
• GSK Investigational Site — Lima, Lima Province, Peru
• GSK Investigational Site — Lima, Lima Province, Peru
• GSK Investigational Site — Lima, Lima Province, Peru
• GSK Investigational Site — Callao, Peru
• GSK Investigational Site — Bydogoszcz, Poland

Full record on ClinicalTrials.gov

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