ELBA: Exemestane and Lapatinib in Advanced Breast Cancer

Breast Cancer Clinical Trial

— ELBA  

Official title:

Phase II Multicentered Study of Exemestane and Lapatinib in Advanced Hormone-responsive Breast Cancer

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01005641
• Other study ID #: ELBA
• Secondary ID: EudraCT number:
• Status: Withdrawn
• Phase: Phase 2
• First received: October 29, 2009
• Last updated: July 12, 2012
• Start date: December 2009
• Est. completion date: March 2012

Study information

• Verified date: July 2012
• Source: National Cancer Institute, Naples
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: March 2012
• Est. primary completion date: October 2011
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A and older

Eligibility

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)

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Drug:
• exemestane
25 mg daily
• lapatinib
taken orally, daily, at dose recommended after dose finding part of study

Locations

Country	Name	City	State
Italy	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

Sponsors (1)

Lead Sponsor	Collaborator
National Cancer Institute, Naples

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Primary	proportion of patients free from progression		at 6 months	No
Secondary	Treatment related toxicity		every 4 weeks	Yes
Secondary	objective response		at 3 and 6 months	No
Secondary	time to progression		at 12 months	No
Secondary	overall survival		18 months	No
Secondary	prognostic role of molecular markers and circulating tumor cells		at 18 months	No