We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Aging Mammary Stem Cells and Breast Cancer Prevention

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02642094
Recruitment Status : Active, not recruiting
First Posted : December 30, 2015
Last Update Posted : March 8, 2022
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
LuZhe Sun, The University of Texas Health Science Center at San Antonio

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:
To examine whether rapamycin can reduce malignant markers and aberrant mammary stem/progenitor cells (MaSCs) number in surgical specimens

Condition or disease Intervention/treatment Phase
Cancer of Breast Drug: Rapamycin Phase 2

Detailed Description:
A non-randomized, open-label, phase II, window of opportunity trial will be carried out to see if a 5-7 day rapamycin treatment can reduce malignant markers and aberrant MaSC number
Study Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Aging Mammary Stem Cells and Breast Cancer Prevention
Actual Study Start Date : July 2016
Actual Primary Completion Date : February 28, 2022
Estimated Study Completion Date : August 2022

Resource links provided by the National Library of Medicine


Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
Experimental: The effect of short-term rapamycin treatment
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.
 Drug: Rapamycin
Low dose of rapamycin at 2 mg/day for -5-7 days of treatment
Other Name: Sirolimus


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. The effect of short-term rapamycin treatment on tumor grade and biomarkers associated with progression to invasive breast cancer [ Time Frame: Tissue samples will be collected 10 days after rapamycin dose for analysis. ]

Other Outcome Measures:
  1. The effect of short-term rapamycin treatment on the presence or absence of necrosis [ Time Frame: A tissue sample will be collected 10 days after rapamycin dose for analysis. ]
  2. The effect of short-term rapamycin treatment on luminal-to-basal epithelial ratio [ Time Frame: A tissue sample will be collected 10 days after rapamycin dose for analysis. ]
  3. The effect of short-term rapamycin treatment on basal and luminal stem/progenitor cell frequency [ Time Frame: A tissue sample will be collected 10 days after rapamycin dose for analysis. ]
  4. The effect of short-term rapamycin treatment on sphere regeneration frequency in serial passages [ Time Frame: A tissue sample will be collected 10 days after rapamycin dose for analysis. ]

Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Women with confirmed menopausal status. All patients who have NOT had a prior bilateral oophorectomy and/or are younger than age 60, will require menopausal status verified by FSH and estradiol local labs.
  • Women diagnosed with DCIS/LCIS, Atypical lobular hyperplasia (ALH) or ADH lesions detected by pathology
  • Women scheduled for mastectomy or lumpectomy after DCIS/LCIS, ALH or ADH diagnosis
  • 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.
  • Women of child-bearing potential must have a negative serum pregnancy test at time of enrollment.
  • Patients must be able to swallow and retain oral medication.
  • All patients must have given signed informed consent prior to registration on study.

  • Patients must have normal organ and marrow function as defined below:

    1. Leukocytes ≥ 3,000/uL
    2. Absolute neutrophil count ≥ 1,500/uL
    3. Platelets ≥ 100,000/uL
    4. AST ≤ 2.5 X ULN
    5. ALT ≤ 2.5 X ULN
    6. Total bili ≤ 1.5 X ULN or Direct bili ≤ 1 X ULN

Exclusion Criteria:

  • Women who are pregnant.
  • Women who are receiving any other concomitant treatment for their DCIS/LCIS, ALH or ADH
  • Women who are taking rapamycin for another diagnosis.
  • Women with an allergy to rapamycin or its derivatives.
  • Active infection requiring systemic therapy.
  • Patients who are taking any pills containing herbal (alternative) medicines are NOT eligible for participation. Patients must be off any such medications by the time of registration.
  • Immunocompromised subjects, including patients with human immunodeficiency virus
  • Women currently taking strong CYP3A4 inducers or inhibitors. Drugs that cannot be coadministered with rapamycin include but are not limited to: Calcium channel blockers: nicardipine, Antifungal agents: clotrimazole, fluconazole, Antibiotics: troleandomycin, Gastrointestinal prokinetic agents: cisapride, metoclopramide, Other drugs: bromocriptine, cimetidine, danazol, HIV-protease inhibitors (e.g., ritonavir, indinavir), Anticonvulsants: carbamazepine, phenobarbital, phenytoin, Antibiotics: rifapentine. The research team can provide a full list of these medications.

  • Patients with any of the following conditions or complications are NOT eligible for participation:

    1. GI tract disease resulting in an inability to take oral medication
    2. Malabsorption syndrome
    3. Require IV alimentation
    4. History of prior surgical procedures affecting absorption
    5. Uncontrolled inflammatory GI disease (e.g., Crohn's, ulcerative colitis)
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02642094


Locations
Layout table for location information
United States, Texas
University of Texas Health Science Center San Antonio
San Antonio, Texas, United States, 78229
Sponsors and Collaborators
LuZhe Sun
National Cancer Institute (NCI)
Investigators
Layout table for investigator information
Principal Investigator: LuZhe Sun, PhD University of Texas Health Science Center San Antonio, Co-PI
Principal Investigator: Ismail Jatoi, MD University of Texas Health Science Center San Antonio
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
Responsible Party: LuZhe Sun, Co-Principal Investigator, The University of Texas Health Science Center at San Antonio
ClinicalTrials.gov Identifier: NCT02642094    
Other Study ID Numbers: CTMS 15-2096
1R01CA192564-01A1 ( U.S. NIH Grant/Contract )
First Posted: December 30, 2015    Key Record Dates
Last Update Posted: March 8, 2022
Last Verified: March 2022

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: Yes
Additional relevant MeSH terms:
Layout table for MeSH terms
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Sirolimus
Anti-Bacterial Agents
 Anti-Infective Agents
Antibiotics, Antineoplastic
Antineoplastic Agents
Antifungal Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs