MedDataX Logo

ELBA: Exemestane and Lapatinib in Advanced Breast Cancer

NCT ID: NCT01005641

Last Updated: 2012-07-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

WITHDRAWN

Clinical Phase

PHASE2

Study Classification

INTERVENTIONAL

Study Start Date

2009-12-31

Study Completion Date

2012-03-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Breast Cancer

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

advanced breast cancer hormone-responsive metastatic breast cancer

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

A

phase II

Group Type EXPERIMENTAL

exemestane

Intervention Type DRUG

25 mg daily

lapatinib

Intervention Type DRUG

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

exemestane

25 mg daily

Intervention Type DRUG

lapatinib

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

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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)
Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

National Cancer Institute, Naples

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

NCI Naples

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Andrea de Matteis, M.D.

Role: PRINCIPAL_INVESTIGATOR

NCI Naples, Division of Medical Oncology C

Francesco Perrone, M.D., Ph.D.

Role: PRINCIPAL_INVESTIGATOR

NCI Naples, Clinical Trials Office

Alessandro Morabito, M.D.

Role: PRINCIPAL_INVESTIGATOR

NCI Naples

Nicola Normanno, M.D.

Role: PRINCIPAL_INVESTIGATOR

NCI Naples

Ciro Gallo, M.D.

Role: PRINCIPAL_INVESTIGATOR

University of Campania Luigi Vanvitelli

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Istituto Nazionale dei Tumori , Divisione di Oncologia Medica B

Napoli, , Italy

Site Status

Istituto Nazionale dei Tumori, Divisione di Oncologia Medica C

Napoli, , Italy

Site Status

Ospedale S. Luca ASL SA 3

Vallo della Lucania, , Italy

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Italy

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

EudraCT number: 2008-007946-67

Identifier Type: -

Identifier Source: secondary_id

ELBA

Identifier Type: -

Identifier Source: org_study_id