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Aging Mammary Stem Cells and Breast Cancer Prevention

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ClinicalTrials.gov Identifier: NCT02642094
Recruitment Status : Recruiting
First Posted : December 30, 2015
Last Update Posted : October 11, 2017
Sponsor:
Information provided by (Responsible Party):
The University of Texas Health Science Center at San Antonio

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 Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Aging Mammary Stem Cells and Breast Cancer Prevention
Study Start Date : July 2016
Estimated Primary Completion Date : December 2021
Estimated Study Completion Date : December 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

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




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. ]


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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 within 50-80 years of age
  • Postmenopausal women defined as:

    1. Prior bilateral oophorectomy
    2. Age ≥60
    3. Age < 60 and amenorrhea for 12 or more months (in the absence of chemotherapy, tamoxifen, toremifen, or ovarian suppression) and FSH and estradiol in the postmenopausal range for the local laboratory.
  • Women diagnosed with DCIS or ADH lesions detected by pathology
  • Women scheduled for mastectomy or lumpectomy after DCIS or ADH diagnosis
  • 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 older than 80 years or younger than 50 years of age.
  • Women who are pregnant.
  • Women who are receiving any other concomitant treatment for their DCIS/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. Appendix 4 has a complete list of these medications.
  • Consent to the tissue CTRC biorepository (HSC20070684H)
  • 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)

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


Contacts
Contact: Epp Goodwin 210-450-1000 ctrcreferral@uthscsa.edu

Locations
United States, Texas
University of Texas Health Science Center San Antonio Recruiting
San Antonio, Texas, United States, 78229
Contact: Epp Goodwin    210-450-1366    ctrcreferral@uthscsa.edu   
Principal Investigator: LuShe Sun, PhD         
Sub-Investigator: Ismail Jatoi, MD         
Sponsors and Collaborators
The University of Texas Health Science Center at San Antonio
Investigators
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

Responsible Party: The University of Texas Health Science Center at San Antonio
ClinicalTrials.gov Identifier: NCT02642094     History of Changes
Other Study ID Numbers: CTMS 15-2096
First Posted: December 30, 2015    Key Record Dates
Last Update Posted: October 11, 2017
Last Verified: October 2017

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Sirolimus
Everolimus
Breast Diseases
Skin Diseases
Anti-Bacterial Agents
Anti-Infective Agents
Antibiotics, Antineoplastic
Antineoplastic Agents
Antifungal Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs