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

Recruiting in Palo Alto (17 mi)

Overseen byStacy Moulder, M.D.

Age: 18+

Sex: Female

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: M.D. Anderson Cancer Center

Stay on Your Current Meds

No Placebo Group

Prior Safety Data

Trial Summary

What is the purpose of this trial?

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.

Eligibility Criteria

Inclusion Criteria

Patients with histologic confirmation of invasive ER/PR and HER2/neu-negative breast carcinoma. Immunohistochemistry (IHC) must be used for ER/PR evaluation and IHC or FISH for determination of HER2/neu. ER/PR will be considered negative if equal or lower than 5% IHC staining and HER2/neu will be considered negative if IHC of 0% or negative FISH.

Patients must have intact primary tumors.

Age equal or greater than 18 years

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Treatment Details

Interventions

5-Fluorouracil (Antimetabolite)
Cyclophosphamide (Alkylating Agent)
Epirubicin (Anthracycline)
Paclitaxel (Taxane)
RAD001 (mTOR Inhibitor)

Participant Groups

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).

5-Fluorouracil is already approved in European Union, United States, Canada, Japan for the following indications:

🇪🇺 Approved in European Union as 5-FU for: