ELBA: Exemestane and Lapatinib in Advanced Breast Cancer

Sponsor
National Cancer Institute, Naples
Study ID
NCT01005641
Phase
PHASE2
Status
Withdrawn

Conditions

Eligibility Criteria

Sex
FEMALE
Age
N/A - N/A
Healthy Volunteers
Not accepted

Interventions

  • exemestane — DRUG
    25 mg daily
  • lapatinib — DRUG
    taken orally, daily, at dose recommended after dose finding part of study

Study Details

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.

Key Dates

Start date
Dec 31, 2009
Status verified
Jul 2012
Primary completion
Oct 31, 2011
Completion
Mar 31, 2012

Study Design

Enrollment
0 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: A
    phase II

Primary Outcome Measure

recommended dose of lapatinib given in combination with standard dose of exemestane in patients with advanced hormone-responsive breast cancer [ Time Frame: one month after dose selection for each of 3 possible dose levels ]

Related Studies