Clinical trial · Interventional
Safety of Everolimus in Combination Therapy, in Patients With HER2-overexpressing Metastatic Breast Cancer
A Phase Ib Study Investigating the Combination of Everolimus With Trastuzumab and Vinorelbine in Patients With HER2-overexpressing Metastatic Breast Cancer
NCT00426530CI-TRIAL-00049014completedPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This study will look at different dose levels and regimens of everolimus combined with weekly trastuzumab and vinorelbine therapy in patients with HER-2 overexpressing metastatic breast cancer.
Conditions
Conditions (2)
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 Neoplasms | Breast Neoplasm | ONTOLOGY_EXACT | 0.98 |
| Neoplasm Metastasis | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| everolimus (RAD001) | Drug | Everolimus | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- RAD001 Daily Schedule
- description
- 5mg or 10mg
- interventionNames
- Drug: everolimus (RAD001)
- type
- EXPERIMENTAL
- label
- RAD001 Weekly Schedule
- description
- 30mg
- interventionNames
- Drug: everolimus (RAD001)
Primary outcomes (1)
- measure
- To establish the feasible dose levels/regimens based on End-of-cycle-1 dose limiting toxicity (DLT)
- timeFrame
- after ever DLT within the first cycle, at least 21 days on treatment, every 2 months from first date of enrollment in a particular regimen
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion criteria: * Female or male patients ≥18 years with WHO performance status ≤ 1 * HER-2 overexpressing metastatic breast cancer cells confirmed by histology * Progressive disease on prior trastuzumab alone/or in combination with other anticancer agents, or relapsed any time after completion of this therapy * Patients neurologically stable with adequate bone marrow, liver and renal function Exclusion criteria: * Patients receiving endocrine therapy for breast cancer ≤ 2 weeks prior to study treatment start * Patients currently receiving chemotherapy, immunotherapy or radiotherapy or who have received these ≤ 4 weeks prior to study treatment start or patients who have received lapatinib ≤ 2 weeks prior to study treatment start * Patients who have previously received vinorelbine or mTOR inhibitors Other protocol-defined inclusion/exclusion criteria may apply
References
Publications (1)
- DERIVEDJerusalem G, Fasolo A, Dieras V, Cardoso F, Bergh J, Vittori L, Zhang Y, Massacesi C, Sahmoud T, Gianni L. Phase I trial of oral mTOR inhibitor everolimus in combination with trastuzumab and vinorelbine in pre-treated patients with HER2-overexpressing metastatic breast cancer. Breast Cancer Res Treat. 2011 Jan;125(2):447-55. doi: 10.1007/s10549-010-1260-x. Epub 2010 Nov 25. PMID 21107682