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

Novartis Pharmaceuticals1 site in 1 country50 target enrollmentFebruary 2007

ConditionsBreast Neoplasms Neoplasm Metastasis

Interventionseverolimus (RAD001)

Drugseverolimus (RAD001)

Overview

Phase: Phase 1
Intervention: everolimus (RAD001)
Conditions: Breast Neoplasms
Sponsor: Novartis Pharmaceuticals
Enrollment: 50
Locations: 1
Primary Endpoint: To establish the feasible dose levels/regimens based on End-of-cycle-1 dose limiting toxicity (DLT)
Status: Completed
Last Updated: 5 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

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.

Registry

clinicaltrials.gov

Start Date

February 2007

End Date

June 2010

Last Updated

5 years ago

Study Type

Interventional

Study Design

Parallel

Sex

Female

Investigators

Sponsor

Novartis Pharmaceuticals

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Arms & Interventions

RAD001 Daily Schedule

5mg or 10mg

Intervention: everolimus (RAD001)

RAD001 Weekly Schedule

30mg

Intervention: everolimus (RAD001)

Outcomes

Primary Outcomes

To establish the feasible dose levels/regimens based on End-of-cycle-1 dose limiting toxicity (DLT)

Time Frame: 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 Outcomes

To assess the ability to deliver the trastuzumab and vinorelbine therapy(After LPLV)
To evaluate the overall tumor response(every 9 weeks/minus 1 week)
To assess everolimus, trastuzumab and vinorelbine blood levels in this combination(After LPLV)