ELBA: Exemestane and Lapatinib in Advanced Breast Cancer

National Cancer Institute, Naples

Status and phase

Withdrawn

Phase 2

Conditions

Breast Cancer

Treatments

Drug: exemestane

Drug: lapatinib

Study type

Interventional

Funder types

Other

Identifiers

NCT01005641

ELBA

EudraCT number: 2008-007946-67

Details and patient eligibility

About

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.

Full 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.

Sex

Female

Volunteers

No Healthy Volunteers

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)