MedTrace Logo

ELBA: Exemestane and Lapatinib in Advanced Breast Cancer

NCT01005641 · Status: WITHDRAWN · Phase: PHASE2 · Type: INTERVENTIONAL

Last updated 2012-07-13

No results posted yet for this study

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.

Conditions

Interventions

DRUG

exemestane

25 mg daily

DRUG

lapatinib

taken orally, daily, at dose recommended after dose finding part of study

Sponsors & Collaborators

  • National Cancer Institute, Naples

    lead OTHER

Principal Investigators

  • Andrea de Matteis, M.D. · NCI Naples, Division of Medical Oncology C

  • Francesco Perrone, M.D., Ph.D. · NCI Naples, Clinical Trials Office

  • Alessandro Morabito, M.D. · NCI Naples

  • Nicola Normanno, M.D. · NCI Naples

  • Ciro Gallo, M.D. · University of Campania Luigi Vanvitelli

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-12-31
Primary Completion
2011-10-31
Completion
2012-03-31

Countries

  • Italy

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01005641 on ClinicalTrials.gov