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

PHASE2UnknownINTERVENTIONAL
Enrollment

62

Participants

Timeline

Start Date

July 31, 2007

Primary Completion Date

April 30, 2012

Study Completion Date

April 30, 2017

Conditions
Breast Cancer
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.

Trial Locations (1)

77030

University of Texas MD Anderson Cancer Center, Houston

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Novartis

INDUSTRY

collaborator

National Cancer Institute (NCI)

NIH

lead

M.D. Anderson Cancer Center

OTHER