Safety of Everolimus in Combination Therapy, in Patients With HER2-overexpressing Metastatic Breast Cancer

Study Overview
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Brief Summary
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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.

Official Title
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A Phase Ib Study Investigating the Combination of Everolimus With Trastuzumab and Vinorelbine in Patients With HER2-overexpressing Metastatic Breast Cancer

Conditions
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Breast Neoplasms, Neoplasm Metastasis

Intervention / Treatment
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* Drug: everolimus (RAD001)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: RAD001 Daily Schedule<br>5mg or 10mg | Drug: everolimus (RAD001)<br> <br> |
| Experimental: RAD001 Weekly Schedule<br>30mg | Drug: everolimus (RAD001)<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To establish the feasible dose levels/regimens based on End-of-cycle-1 dose limiting toxicity (DLT) |  | 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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To assess the ability to deliver the trastuzumab and vinorelbine therapy |  | After LPLV | 
| To assess everolimus, trastuzumab and vinorelbine blood levels in this combination |  | After LPLV | 
| To evaluate the overall tumor response |  | every 9 weeks/minus 1 week | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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HER2-overexpressing metastatic breast cancer, Breast cancer, Cancer of the breast, Human mammary carcinoma, HER-2, metastatic, everolimus, trastuzumab, vinorelbine