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mTOR Inhibitor

Rapamycin for Breast Cancer

Phase 2
Waitlist Available
Led By LuZhe Sun, PhD
Research Sponsored by LuZhe Sun
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Women consented to the UT Health Cancer Center MD Anderson Cancer Center tissue biorepository (HSC20070684H)
Women of child-bearing potential willing to practice 2 forms of contraception, one of which must be a barrier method until at least 30 days after the last dose of rapamycin.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline to 5-7 day rapamycin plus 3-7 day washout
Awards & highlights

Study Summary

This study is evaluating whether a drug may help reduce the number of cancerous cells in breast tissue.

Eligible Conditions
  • Breast Cancer

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline to 5-7 day rapamycin plus 3-7 day washout
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline to 5-7 day rapamycin plus 3-7 day washout for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
The Effect of Short-term Rapamycin Treatment on Biomarker Ki67 Associated With Progression to Invasive Breast Cancer
The Effect of Short-term Rapamycin Treatment on Sphere Formation Efficiency of Luminal Progenitor Cells
The Effect of Short-term Rapamycin Treatment on Sphere Formation Efficiency of Mammary Stem Cells
+2 more
Other outcome measures
The effect of short-term rapamycin treatment on basal and luminal stem/progenitor cell frequency
The effect of short-term rapamycin treatment on luminal-to-basal epithelial ratio
The effect of short-term rapamycin treatment on sphere regeneration frequency in serial passages
+1 more

Side effects data

From 2009 Phase 4 trial • 20 Patients • NCT00223678
31%
pneumonia
15%
acute kidney failure
8%
dehydration
8%
hip replacement
8%
acute rejection
8%
total abdominal hysterectomy and salpingectomy
8%
anemia
100%
80%
60%
40%
20%
0%
Study treatment Arm
Rapamycin Group
CNI Group

Trial Design

1Treatment groups
Experimental Treatment
Group I: The effect of short-term rapamycin treatmentExperimental Treatment1 Intervention
Subjects will be given a low dose of rapamycin at 2 mg/day for 5-7 days of treatment. A surgical specimen will be taken 3-7 days after the last dose of rapamycin. The specimens will be evaluated for lesion size, nuclear grade, presence of necrosis in each patient's core biopsy and surgical specimens, as well as IHC (ImmunoHistoChemistry) for biomarkers including p16, COX2 (cyclooxygenase-2), and Ki-67. Specimens will also be tested for rapamycin treatment on the properties of mammary stem/progenitor cells as another biomarker for gauging the efficacy of rapamycin treatment.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Rapamycin
2008
Completed Phase 4
~1200

Find a Location

Who is running the clinical trial?

LuZhe SunLead Sponsor
National Cancer Institute (NCI)NIH
13,607 Previous Clinical Trials
40,914,104 Total Patients Enrolled
938 Trials studying Breast Cancer
1,543,275 Patients Enrolled for Breast Cancer
LuZhe Sun, PhDPrincipal Investigator - University of Texas Health Science Center San Antonio, Co-PI
The University of Texas Health Science Center at San Antonio

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
~7 spots leftby Mar 2025