ELBA: Exemestane and Lapatinib in Advanced Breast Cancer

This study has been withdrawn prior to enrollment.
(Study not started for administrative reasons)
Sponsor:
Information provided by:
National Cancer Institute, Naples
ClinicalTrials.gov Identifier:
NCT01005641
First received: October 29, 2009
Last updated: July 12, 2012
Last verified: July 2012
  Purpose

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 Intervention Phase
Breast Cancer
Drug: exemestane
Drug: lapatinib
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase II Multicentered Study of Exemestane and Lapatinib in Advanced Hormone-responsive Breast Cancer

Resource links provided by NLM:


Further study details as provided by National Cancer Institute, Naples:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]
  • proportion of patients free from progression [ Time Frame: at 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Treatment related toxicity [ Time Frame: every 4 weeks ] [ Designated as safety issue: Yes ]
  • objective response [ Time Frame: at 3 and 6 months ] [ Designated as safety issue: No ]
  • time to progression [ Time Frame: at 12 months ] [ Designated as safety issue: No ]
  • overall survival [ Time Frame: 18 months ] [ Designated as safety issue: No ]
  • prognostic role of molecular markers and circulating tumor cells [ Time Frame: at 18 months ] [ Designated as safety issue: No ]

Enrollment: 0
Study Start Date: December 2009
Estimated Study Completion Date: March 2012
Estimated Primary Completion Date: October 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A
phase II
Drug: exemestane
25 mg daily
Drug: lapatinib
taken orally, daily, at dose recommended after dose finding part of study

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.

  Eligibility

Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01005641

Locations
Italy
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
Investigators
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. Second University of Naples
  More Information

No publications provided

Responsible Party: Francesco Perrone, NCI Naples
ClinicalTrials.gov Identifier: NCT01005641     History of Changes
Other Study ID Numbers: ELBA, EudraCT number: 2008-007946-67
Study First Received: October 29, 2009
Last Updated: July 12, 2012
Health Authority: Italy: Ethics Committee

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

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Lapatinib
Exemestane
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Aromatase Inhibitors

ClinicalTrials.gov processed this record on September 18, 2014