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Erlotinib and Everolimus in Treating Patients With Metastatic Breast Cancer

NCT00574366 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 14

Last updated 2016-05-10

No results posted yet for this study

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.

Conditions

Interventions

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

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    collaborator NIH

  • Vanderbilt-Ingram Cancer Center

    lead OTHER

Principal Investigators

  • Ingrid Mayer, MD · Vanderbilt-Ingram Cancer Center

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2005-12-31
Primary Completion
2009-01-31
Completion
2009-02-28

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00574366 on ClinicalTrials.gov