NCT00574366

Erlotinib and Everolimus in Treating Patients With Metastatic Breast Cancer

A Phase I/II Trial of an Oral MTOR Protein Kinase Inhibitor (Everolimus, RAD001) in Combination With an Oral EGFR Tyrosine Kinase Inhibitor (Erlotinib, Tarceva™) In Patients With Metastatic Breast Cancer

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 14 (actual)
• Sponsor: Vanderbilt-Ingram Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

RATIONALE: Erlotinib and everolimus may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving erlotinib together with everolimus may kill more tumor cells. PURPOSE: This phase I/II trial is studying the side effects and best dose of giving erlotinib together with everolimus and to see how well it works in treating patients with metastatic breast cancer.

Detailed description

OBJECTIVES: Primary * To determine the safety of everolimus given in combination with erlotinib hydrochloride in patients with metastatic breast cancer (phase I). * To determine the antitumor activity of the combination (phase II). * Determine the rate of clinical benefit (complete response + partial response + stable disease for at least 6 months) in patients with metastatic breast cancer (phase II). Secondary * To determine the time to progression. * To determine PTEN, pAkt, pP70S6K1 and pEGFR in primary tumors at baseline. OUTLINE: This is an open-label, dose escalation phase I study followed by an open-label phase II study. * Phase I: Patients receive escalating doses of oral everolimus and oral erlotinib hydrochloride once daily until the maximum tolerated dose (MTD) is determined. Treatment repeats every 4 weeks in the absence of disease progression or unacceptable toxicity. Once the MTD is reached, the recommended dose to be used in the phase II portion of the study is identified. * Phase II: Patients receive oral everolimus and oral erlotinib hydrochloride as in phase I at the recommended phase II dose determined in phase I. Patients undergo tissue collection to evaluate tumor levels of PTEN, pAkt, pP70S6K1, and pEGFR at baseline in order to identify predictors of therapeutic response. After completion of study treatment, patients are followed every 3 months for 2 years (from study entry), every 6 months for 3 years, and annually thereafter. NOTE: Phase I completed. Investigator did not proceed with Phase II

Conditions

• Breast Cancer

Interventions

Type	Name	Description
DRUG	erlotinib	Levels: * 1 Erlotinib 50 mg/d * 2 Erlotinib 50 mg/d * 1 Erlotinib 100 mg/d * 2 Erlotinib 100 mg/d * 3 Erlotinib 150 mg/d * 4 Erlotinib 150 mg/d
DRUG	RAD001	Levels minus 1: RAD001 2.5 mg/d minus 2: RAD001 2.5 every other day 1. RAD001 2.5 mg per day 2. RAD001 5 mg per day 3. RAD001 10 mg per day 4. RAD001 10 mg per day

Timeline

• Start date: 2005-12-01
• Primary completion: 2009-01-01
• Completion: 2009-02-01
• First posted: 2007-12-17
• Last updated: 2016-05-10

Locations

3 sites across 1 country: United States