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

Phase 1

Completed

• Conditions: Breast Neoplasms; Neoplasm Metastasis
• Interventions: Drug: everolimus (RAD001)

• Registration Number: NCT00426530
• Lead Sponsor: Novartis Pharmaceuticals

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2007-01-23
• Study First Submitted QC: 2007-01-23
• Study First Posted: 2007-01-24
• Study Start: 2007-02
• Primary Completion: 2010-06
• Study Completion: 2010-06
• Status Verified: 2016-04
• Last Update Submitted: 2020-12-17
• Last Update Posted: 2020-12-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 50

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
RAD001 Daily Schedule	everolimus (RAD001)	5mg or 10mg
RAD001 Weekly Schedule	everolimus (RAD001)	30mg

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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

Trial Locations

Locations (1)

Novartis Investigative Site; 🇸🇪 Stockholm, Sweden