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Antimetabolite

Paclitaxel + FEC for 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

Study 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 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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Number Participants With Inhibition of PI3K/PTEN/AKT Pathway at 48 Hours
Secondary outcome measures
Participant Responses Per Treatment Arm at 12 Weeks
Participant Responses Per Treatment Arm at 24 Weeks

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
Paclitaxel
FDA approved

Find a Location

Who is running the clinical trial?

M.D. Anderson Cancer CenterLead Sponsor
2,972 Previous Clinical Trials
1,787,255 Total Patients Enrolled
147 Trials studying Breast Cancer
63,224 Patients Enrolled for Breast Cancer
NovartisIndustry Sponsor
1,611 Previous Clinical Trials
2,720,973 Total Patients Enrolled
56 Trials studying Breast Cancer
21,126 Patients Enrolled for Breast Cancer
National Cancer Institute (NCI)NIH
13,660 Previous Clinical Trials
40,924,459 Total Patients Enrolled
939 Trials studying Breast Cancer
1,543,298 Patients Enrolled for Breast Cancer

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
Paclitaxel Followed by FEC Versus Paclitaxel and RAD001 Followed by FEC In Women With Breast Cancer
2007. "Paclitaxel Followed by FEC Versus Paclitaxel and RAD001 Followed by FEC In Women With Breast Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT00499603.
All > Acl > Breast
~3 spots leftby Apr 2025
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