ELBA: Exemestane and Lapatinib in Advanced Breast Cancer
Information source: National Cancer Institute, Naples
ClinicalTrials.gov processed this data on August 20, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Breast Cancer
Intervention: exemestane (Drug); lapatinib (Drug)
Phase: Phase 2
Status: Withdrawn
Sponsored by: National Cancer Institute, Naples Official(s) and/or principal investigator(s): Andrea de Matteis, M.D., Principal Investigator, Affiliation: NCI Naples, Division of Medical Oncology C Francesco Perrone, M.D., Ph.D., Principal Investigator, Affiliation: NCI Naples, Clinical Trials Office Alessandro Morabito, M.D., Principal Investigator, Affiliation: NCI Naples Nicola Normanno, M.D., Principal Investigator, Affiliation: NCI Naples Ciro Gallo, M.D., Principal Investigator, Affiliation: Second University of Naples
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.
Clinical Details
Official title: Phase II Multicentered Study of Exemestane and Lapatinib in Advanced Hormone-responsive Breast Cancer
Study design: Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: recommended dose of lapatinib given in combination with standard dose of exemestane in patients with advanced hormone-responsive breast cancerproportion of patients free from progression
Secondary outcome: Treatment related toxicityobjective response time to progression overall survival prognostic role of molecular markers and circulating tumor cells
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
Minimum age: N/A.
Maximum age: N/A.
Gender(s): Female.
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)
Locations and Contacts
Istituto Nazionale dei Tumori , Divisione di Oncologia Medica B, Napoli 80131, Italy
Istituto Nazionale dei Tumori, Divisione di Oncologia Medica C, Napoli 80131, Italy
Ospedale S. Luca ASL SA 3, Vallo della Lucania, Italy
Additional Information
Starting date: December 2009
Last updated: July 12, 2012
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