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

2014-08-27 03:12:10 | BioPortfolio

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.

Description

This is an open-label Phase 2 neoadjuvant study for patients with histologically confirmed, HER-2 positive operable breast cancer. All patients will receive 18 weeks of neoadjuvant treatment.

The trial has an initial 2 week "biomarker lead in" phase. During this two week phase patients will either receive Trastuzumab alone or Trastuzumab + Everolimus. This two week lead in phase will be randomized open label. The rest of the 16 weeks of the neoadjuvant trial treatment is non randomized open label.

For the first two weeks of neoadjuvant treatment the eligible subjects will be randomly assigned to either receive or not receive Everolimus. This assignment will be accomplished by a previously prepared schedule (maintained by the investigational pharmacy), such that investigators are unaware of assignment until after the subject has been enrolled on the study and received assignment of Everolimus or not.

Study Design

Allocation: Randomized, Control: Active Control, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Conditions

Breast Cancer

Intervention

paclitaxel

Location

University of Kansas Medical Center
Kansas City
Kansas
United States
66160

Status

Recruiting

Source

University of Kansas

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:12:10-0400

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