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A Study to Look at the Combination of Chemotherapy, Trastuzumab and RAD001 in HER2 Positive Breast Cancer

NCT01163929 · Status: WITHDRAWN · Phase: PHASE2 · Type: INTERVENTIONAL

Last updated 2012-10-24

No results posted yet for this study

Summary

The primary objective of this study is to assess whether a combination of chemotherapy, Trastuzumab and RAD001 will result in no evidence of microscopic disease at the time of surgery in 50% of enrolled patients.

Conditions

Interventions

DRUG

paclitaxel

Paclitaxel: 80mg/m2 IV TRO 3 hours every 28 days for 4 cycles Trastuzumab: 4mg/kg IV load dose (TRO 90) minutes followed by 2 mg/kg TRO 60 minutes every week for 18 weeks Everolimus: 10mg PO daily 16-18 weeks

Sponsors & Collaborators

  • Novartis

    collaborator INDUSTRY

  • University of Kansas

    lead OTHER

Principal Investigators

  • Priyanka Sharma, MD · University of Kansas Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-07-31
Primary Completion
2012-03-31
Completion
2012-03-31

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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 NCT01163929 on ClinicalTrials.gov