ELBA: Exemestane and Lapatinib in Advanced Breast Cancer (ELBA)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01005641
Recruitment Status : Withdrawn (Study not started for administrative reasons)
First Posted : November 2, 2009
Last Update Posted : July 13, 2012
Information provided by:
National Cancer Institute, Naples

October 29, 2009
November 2, 2009
July 13, 2012
December 2009
October 2011   (Final data collection date for 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 ]
  • proportion of patients free from progression [ Time Frame: at 6 months ]
Same as current
Complete list of historical versions of study NCT01005641 on Archive Site
  • Treatment related toxicity [ Time Frame: every 4 weeks ]
  • objective response [ Time Frame: at 3 and 6 months ]
  • time to progression [ Time Frame: at 12 months ]
  • overall survival [ Time Frame: 18 months ]
  • prognostic role of molecular markers and circulating tumor cells [ Time Frame: at 18 months ]
Same as current
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ELBA: Exemestane and Lapatinib in Advanced Breast Cancer
Phase II Multicentered Study of Exemestane and Lapatinib in Advanced Hormone-responsive Breast Cancer
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.
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.
Phase 2
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Breast Cancer
  • Drug: exemestane
    25 mg daily
  • Drug: lapatinib
    taken orally, daily, at dose recommended after dose finding part of study
Experimental: A
phase II
  • Drug: exemestane
  • Drug: lapatinib
Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
March 2012
October 2011   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Histological diagnosis of breast cancer
  • Indication for hormonal therapy (ER and/or PgR positive)
  • Stage IV disease
  • Female gender
  • Postmenopausal status (patients treated with LHRH analogs are eligible for the Phase II part of the study)
  • At least one target or non-target lesion according to RECIST criteria
  • ECOG Performance Status 0-2
  • Adequate bone marrow (neutrophils > or = 1.500/mm³, platelets > or = 100.000/mm³ and hemoglobin > or = 9 g/dl), hepatic (GOT, GPT < 2.5 e bilirubin <1.25 times the value of upper normal limit) and renal (creatinine < 1.25 times the value of upper normal limit) function
  • Adequate cardiac function (FEVS > or = 50%)
  • Able to take oral medications
  • Life expectancy > 3 months
  • Signed informed consent

Exclusion Criteria:

  • Any previous hormone therapy for metastatic disease
  • More than one line of chemotherapy for metastatic disease (first line chemotherapy is permitted)
  • Symptomatic cerebral metastases
  • Planned concomitant radiation therapy in the first month of therapy (for those patients participating in the dose finding phase of the study)
  • Previous therapy with exemestane, including as adjuvant therapy (previous therapy with non-steroidal aromatase inhibitors is permitted)
  • Previous or concurrent malignancy in past 5 years (excluding adequately treated basal cel or spinocellular skin cancer and in situ carcinoma of the cervix)
  • Treatment with experimental pharmacologic therapy within 4 weeks of enrollment in the study
  • Unable or unwilling to provide signed informed consent
  • Any concurrent illness that would, in the Investigator's opinion, contraindicate the use of the study drugs.
  • Active infection
  • Assumption of CYP3A4 inhibitors or inducers (ketoconazole, itraconazole, fluconazole, macrolide antibiotics, antidepressives, calcium-antagonists, cimetidine, carbamazepine, phenytoin, barbiturates, rifampicin e glucocorticoids)
  • Pregnancy or lactation
  • Unable to comply with follow-up
  • Active hepatobiliary disease (with the exception of Gilbert's syndrome, asymptomatic biliary calculi, hepatic metastases or stabile chronic hepatopathy)
Sexes Eligible for Study: Female
Child, Adult, Senior
Contact information is only displayed when the study is recruiting subjects
EudraCT number: 2008-007946-67
Not Provided
Not Provided
Francesco Perrone, NCI Naples
National Cancer Institute, Naples
Not Provided
Principal Investigator: Andrea de Matteis, M.D. NCI Naples, Division of Medical Oncology C
Principal Investigator: Francesco Perrone, M.D., Ph.D. NCI Naples, Clinical Trials Office
Principal Investigator: Alessandro Morabito, M.D. NCI Naples
Principal Investigator: Nicola Normanno, M.D. NCI Naples
Principal Investigator: Ciro Gallo, M.D. University of Campania "Luigi Vanvitelli"
National Cancer Institute, Naples
July 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP