NCT01005641

ELBA: Exemestane and Lapatinib in Advanced Breast Cancer

Phase II Multicentered Study of Exemestane and Lapatinib in Advanced Hormone-responsive Breast Cancer

• Status: Withdrawn
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: National Cancer Institute, Naples · Academic / Other
• Sex: Female
• Age: —
• Healthy volunteers: Not accepted

Summary

Aromatase inhibitors are the standard treatment for hormone responsive advanced breast cancer. The combination of the aromatase inhibitor exemestane with with another breast cancer drug that blocks epidermal growth factor receptor (EGFR) and Erb-2 activity (lapatinib) is being studied for the possibility of improving response to therapy, and delaying resistance to endocrine therapy.

Detailed description

The recommended dose of lapatinib will be determined in the first part of the study. In the second part of the study, patients will receive the recommended dose of lapatinib and exemestane daily, taken orally.

Conditions

• Breast Cancer

Interventions

Type	Name	Description
DRUG	exemestane	25 mg daily
DRUG	lapatinib	taken orally, daily, at dose recommended after dose finding part of study

Timeline

• Start date: 2009-12-01
• Primary completion: 2011-10-01
• Completion: 2012-03-01
• First posted: 2009-11-02
• Last updated: 2012-07-13

Locations

3 sites across 1 country: Italy