Clinical trial · Interventional
ELBA: Exemestane and Lapatinib in Advanced Breast Cancer
Phase II Multicentered Study of Exemestane and Lapatinib in Advanced Hormone-responsive Breast Cancer
NCT01005641CI-TRIAL-00007418ELBAwithdrawnPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Study not started for administrative reasons
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| exemestane | Drug | Exemestane | ALIAS |
| lapatinib | Drug | Lapatinib | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- A
- description
- phase II
- interventionNames
- Drug: exemestane
- Drug: lapatinib
Primary outcomes (2)
- measure
- recommended dose of lapatinib given in combination with standard dose of exemestane in patients with advanced hormone-responsive breast cancer
- timeFrame
- one month after dose selection for each of 3 possible dose levels
- measure
- proportion of patients free from progression
- timeFrame
- at 6 months
Secondary outcomes (5)
- measure
Eligibility
Eligibility (as posted)
- Sex
- Female
Show eligibility criteria text
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)
References
Publications (0)
Data not yet available
No reference posted for this study.