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Paclitaxel Followed by FEC Versus Paclitaxel and RAD001 Followed by FEC In Women With Breast Cancer

NCT00499603 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 62

Last updated 2016-11-01

Study results available
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Summary

The goal of this clinical research is to learn if RAD001 given in combination with chemotherapy will turn off the signaling pathway (a chain of information that tells cancer cells to grow quickly) and make the chemotherapies given on this study more effective.

Primary Objective

· To determine if the addition of an mTOR inhibitor to standard neoadjuvant chemotherapy in patients with triple receptor-negative breast cancer causes molecular changes (inhibition/activation) of the PI3K/PTEN/AKT pathway.

Secondary Objectives

* To evaluate pathologic complete response (pCR) rates for each treatment group.
* To evaluate the relationship between pCR and the molecular changes (inhibition/activation) of the PI13K/PTEN/AKT pathway in each treatment group.
* To evaluate overall response rates (ORR) for each treatment group.
* To assess the toxicity of both regimens and to evaluate the relationship of toxicities with PI3K/PTEN/AKT pathway status.

Conditions

Interventions

DRUG

Paclitaxel

80 mg/m\^2 by vein once weekly over 1 hour on day 1(+/- 2 days) each week for 3 weeks and for 12 cycles.

DRUG

5-Fluorouracil

500 mg/m\^2 by vein on day 1 every 3 weeks (+/- 7 days) for 4 cycles.

DRUG

Epirubicin

100 mg/m\^2 by vein on day 1 every 3 weeks (+/- 7 days) for 4 cycles.

DRUG

Cyclophosphamide

500 mg/m\^2 by vein on day 1 every 3 weeks (+/- 7 days) for 4 cycles.

DRUG

RAD001

30 mg by mouth weekly on Days 1, 8, \& 15 for 12 cycles.

Sponsors & Collaborators

  • Novartis

    collaborator INDUSTRY

  • National Cancer Institute (NCI)

    collaborator NIH

  • M.D. Anderson Cancer Center

    lead OTHER

Principal Investigators

  • Stacy Moulder, M.D. · M.D. Anderson Cancer Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-07-31
Primary Completion
2012-04-30
Completion
2017-04-30

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases
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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 NCT00499603 on ClinicalTrials.gov