ELBA: Exemestane and Lapatinib in Advanced Breast Cancer

NCT01005641 | Withdrawn Phase 2

• 2 other identifiers: ELBAEudraCT number: 2008-007946-67
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 3

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.

Conditions

Breast Cancer

Keywords

advanced breast cancer; hormone-responsive; metastatic breast cancer

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (5)

• Treatment related toxicity

  every 4 weeks

• objective response

  at 3 and 6 months

• time to progression

  at 12 months

• overall survival

  18 months

• prognostic role of molecular markers and circulating tumor cells

  at 18 months

Study Arms (1)

A

EXPERIMENTAL

phase II

Drug: exemestane; Drug: lapatinib

Interventions

exemestane DRUG

25 mg daily

A

lapatinib DRUG

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

A

Eligibility Criteria

• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• National Cancer Institute, Naples: lead

Study Sites (3)

Istituto Nazionale dei Tumori , Divisione di Oncologia Medica B

Napoli, 80131, Italy

Location

Istituto Nazionale dei Tumori, Divisione di Oncologia Medica C

Napoli, 80131, Italy

Location

Ospedale S. Luca ASL SA 3

Vallo della Lucania, Italy

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

exemestane; Lapatinib

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Quinazolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Andrea de Matteis, M.D.

  NCI Naples, Division of Medical Oncology C

  PRINCIPAL INVESTIGATOR

• Francesco Perrone, M.D., Ph.D.

  NCI Naples, Clinical Trials Office

  PRINCIPAL INVESTIGATOR

• Alessandro Morabito, M.D.

  NCI Naples

  PRINCIPAL INVESTIGATOR

• Nicola Normanno, M.D.

  NCI Naples

  PRINCIPAL INVESTIGATOR

• Ciro Gallo, M.D.

  University of Campania Luigi Vanvitelli

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: October 29, 2009
• First Posted: November 2, 2009
• Study Start: December 1, 2009
• Primary Completion: October 1, 2011
• Study Completion: March 1, 2012
• Last Updated: July 13, 2012

Record last verified: 2012-07

Locations

IT (3)