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Antimetabolite

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

Phase 2

Waitlist Available

Led By Stacy Moulder, M.D.

Research Sponsored by M.D. Anderson Cancer Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 48 hours after start of treatment

Awards & highlights

Approved for 20 Other Conditions

All Individual Drugs Already Approved

No Placebo-Only Group

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.

Eligible Conditions

Breast Cancer

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 48 hours after start of treatment

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~48 hours after start of treatment

This trial's timeline: 3 weeks for screening, Varies for treatment, and 48 hours after start of treatment for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Number Participants With Inhibition of PI3K/PTEN/AKT Pathway at 48 Hours

Secondary study objectives

Participant Responses Per Treatment Arm at 12 Weeks

Participant Responses Per Treatment Arm at 24 Weeks

Awards & Highlights

Approved for 20 Other Conditions

This treatment demonstrated efficacy for 20 other conditions.

All Individual Drugs Already Approved

Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Group I: Paclitaxel + RAD001 + FECExperimental Treatment5 Interventions

Paclitaxel + RAD001 Followed by FEC (5-Fluorouracil + Epirubicin + Cyclophosphamide)

Group II: Paclitaxel + FECExperimental Treatment4 Interventions

Paclitaxel 80 mg/m\^2 intravenously (IV) on day 1(+/- 2 days) of each week, followed by four cycles of combination 5-Fluorouracil at 500 mg/m\^2, Epirubicin at 100 mg/m\^2 and Cyclophosphamide at 500 mg/m\^2 (FEC) on day 1 every 3 weeks (+/- 7 days).

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Fluorouracil

FDA approved

Cyclophosphamide

FDA approved

Everolimus

FDA approved

Epirubicin

FDA approved