ELBA: Exemestane and Lapatinib in Advanced Breast Cancer
- Registration Number
- NCT01005641
- Lead Sponsor
- 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.
- 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.
Recruitment & Eligibility
- Status
- WITHDRAWN
- Sex
- Female
- Target Recruitment
- Not specified
- 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
- 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)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description A exemestane phase II A lapatinib phase II
- Primary Outcome Measures
Name Time Method recommended dose of lapatinib given in combination with standard dose of exemestane in patients with advanced hormone-responsive breast cancer one month after dose selection for each of 3 possible dose levels proportion of patients free from progression at 6 months
- Secondary Outcome Measures
Name Time Method time to progression at 12 months overall survival 18 months Treatment related toxicity every 4 weeks objective response at 3 and 6 months prognostic role of molecular markers and circulating tumor cells at 18 months
Trial Locations
- Locations (3)
Istituto Nazionale dei Tumori , Divisione di Oncologia Medica B
🇮🇹Napoli, Italy
Istituto Nazionale dei Tumori, Divisione di Oncologia Medica C
🇮🇹Napoli, Italy
Ospedale S. Luca ASL SA 3
🇮🇹Vallo della Lucania, Italy