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ELBA: Exemestane and Lapatinib in Advanced Breast Cancer

Information source: National Cancer Institute, Naples
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Breast Cancer

Intervention: exemestane (Drug); lapatinib (Drug)

Phase: Phase 2

Status: Withdrawn

Sponsored by: National Cancer Institute, Naples

Official(s) and/or principal investigator(s):
Andrea de Matteis, M.D., Principal Investigator, Affiliation: NCI Naples, Division of Medical Oncology C
Francesco Perrone, M.D., Ph.D., Principal Investigator, Affiliation: NCI Naples, Clinical Trials Office
Alessandro Morabito, M.D., Principal Investigator, Affiliation: NCI Naples
Nicola Normanno, M.D., Principal Investigator, Affiliation: NCI Naples
Ciro Gallo, M.D., Principal Investigator, Affiliation: Second University of Naples

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.

Clinical Details

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

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

Primary outcome:

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:

Treatment related toxicity

objective response

time to progression

overall survival

prognostic role of molecular markers and circulating tumor cells

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.

Eligibility

Minimum age: N/A. Maximum age: N/A. Gender(s): Female.

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)

Locations and Contacts

Istituto Nazionale dei Tumori , Divisione di Oncologia Medica B, Napoli 80131, Italy

Istituto Nazionale dei Tumori, Divisione di Oncologia Medica C, Napoli 80131, Italy

Ospedale S. Luca ASL SA 3, Vallo della Lucania, Italy

Additional Information

Starting date: December 2009
Last updated: July 12, 2012

Page last updated: August 20, 2015

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