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ELBA: Exemestane and Lapatinib in Advanced Breast Cancer (ELBA)

Primary Purpose

Breast Cancer

Status

Withdrawn

Phase

Phase 2

Locations

Italy

Study Type

Interventional

Intervention

exemestane

lapatinib

About this trial

This is an interventional treatment trial for Breast Cancer focused on measuring advanced breast cancer, hormone-responsive, metastatic breast cancer

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)FemaleDoes not accept 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)

Sites / Locations

Istituto Nazionale dei Tumori , Divisione di Oncologia Medica B
Istituto Nazionale dei Tumori, Divisione di Oncologia Medica C
Ospedale S. Luca ASL SA 3

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Arm Description

phase II

Outcomes

Primary Outcome Measures

recommended dose of lapatinib given in combination with standard dose of exemestane in patients with advanced hormone-responsive breast cancer

proportion of patients free from progression

Secondary Outcome Measures

Treatment related toxicity

objective response

time to progression

overall survival

prognostic role of molecular markers and circulating tumor cells

Full Information

NCT ID

NCT01005641

First Posted

October 29, 2009

Last Updated

July 12, 2012

Sponsor

National Cancer Institute, Naples

1. Study Identification

Unique Protocol Identification Number

NCT01005641

Brief Title

ELBA: Exemestane and Lapatinib in Advanced Breast Cancer

Acronym

ELBA

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

July 2012

Overall Recruitment Status

Withdrawn

Why Stopped

Study not started for administrative reasons

Study Start Date

December 2009 (undefined)

Primary Completion Date

October 2011 (Anticipated)

Study Completion Date

March 2012 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor

National Cancer Institute, Naples

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Breast Cancer

Keywords

advanced breast cancer, hormone-responsive, metastatic breast cancer

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

0 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Experimental

Arm Description

phase II

Intervention Type

Drug

Intervention Name(s)

exemestane

Intervention Description

25 mg daily

Intervention Type

Drug

Intervention Name(s)

lapatinib

Intervention Description

taken orally, daily, at dose recommended after dose finding part of study

Primary Outcome Measure Information:

Title

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

Title

proportion of patients free from progression

Time Frame

at 6 months

Secondary Outcome Measure Information:

Title

Treatment related toxicity

Time Frame

every 4 weeks

Title

objective response

Time Frame

at 3 and 6 months

Title

time to progression

Time Frame

at 12 months

Title

overall survival

Time Frame

18 months

Title

prognostic role of molecular markers and circulating tumor cells

Time Frame

at 18 months

10. Eligibility

Sex

Female

Accepts Healthy Volunteers

Eligibility 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)

Overall Study Officials: