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Trastuzumab With or Without Everolimus in Treating Women With Breast Cancer That Can Be Removed By Surgery

NCT00674414 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 82

Last updated 2013-01-18

No results posted yet for this study

Summary

RATIONALE: Monoclonal antibodies, such as trastuzumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Everolimus may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor. It is not yet known whether giving everolimus together with trastuzumab is more effective than giving trastuzumab alone in treating women with breast cancer.

PURPOSE: This randomized phase II trial is studying trastuzumab and everolimus to see how well they work compared to trastuzumab alone before surgery in treating patients with breast cancer that can be removed by surgery.

Conditions

Interventions

BIOLOGICAL

trastuzumab

Trastuzumab (Herceptin®) IV once weekly

DRUG

everolimus

Oral everolimus once daily

PROCEDURE

therapeutic conventional surgery

Patients undergo surgery

Sponsors & Collaborators

  • UNICANCER

    lead OTHER

Principal Investigators

  • Mario Campone, MD · Centre Regional Rene Gauducheau

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-04-30
Primary Completion
2013-01-31

Countries

  • France

Study Locations

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Entities

Drugs
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 NCT00674414 on ClinicalTrials.gov