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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Recruitment Status : Withdrawn (Study not started for administrative reasons)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

Brief 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.

Condition or disease Intervention/treatment Phase
Breast Cancer Drug: exemestane Drug: lapatinib Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase II Multicentered Study of Exemestane and Lapatinib in Advanced Hormone-responsive Breast Cancer
Study Start Date : December 2009
Estimated Primary Completion Date : October 2011
Estimated Study Completion Date : March 2012

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: A
phase II
Drug: exemestane
25 mg daily

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

Primary Outcome Measures :
  1. 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 ]
  2. proportion of patients free from progression [ Time Frame: at 6 months ]

Secondary Outcome Measures :
  1. Treatment related toxicity [ Time Frame: every 4 weeks ]
  2. objective response [ Time Frame: at 3 and 6 months ]
  3. time to progression [ Time Frame: at 12 months ]
  4. overall survival [ Time Frame: 18 months ]
  5. prognostic role of molecular markers and circulating tumor cells [ Time Frame: at 18 months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01005641

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Istituto Nazionale dei Tumori , Divisione di Oncologia Medica B
Napoli, Italy, 80131
Istituto Nazionale dei Tumori, Divisione di Oncologia Medica C
Napoli, Italy, 80131
Ospedale S. Luca ASL SA 3
Vallo della Lucania, Italy
Sponsors and Collaborators
National Cancer Institute, Naples
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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"

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Responsible Party: Francesco Perrone, NCI Naples Identifier: NCT01005641     History of Changes
Other Study ID Numbers: ELBA
EudraCT number: 2008-007946-67
First Posted: November 2, 2009    Key Record Dates
Last Update Posted: July 13, 2012
Last Verified: July 2012

Keywords provided by National Cancer Institute, Naples:
advanced breast cancer
metastatic breast cancer

Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Aromatase Inhibitors
Steroid Synthesis Inhibitors
Estrogen Antagonists
Hormone Antagonists