Trial record 2 of 216125 for:    ALL

Pilot Study of Bisphosphonates for Breast Cancer

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified May 2016 by University of Wisconsin, Madison
Sponsor:
Collaborators:
National Cancer Institute (NCI)
Wisconsin Partnership Program
Information provided by (Responsible Party):
University of Wisconsin, Madison
ClinicalTrials.gov Identifier:
NCT02781805
First received: May 20, 2016
Last updated: NA
Last verified: May 2016
History: No changes posted
  Purpose
The goal of this study is to mechanistically define the potential anticancer activities of the osteoporosis bisphosphonate (BP) drug alendronate, and extend the analysis to learn novel information about the impact of BP on gamma delta (γδ) T cells in breast tissues as well as epithelial breast cell differentiation of high-risk women. To this end, we have designed a BP "window trial" to examine the effect of 1 - 3 weeks administration of alendronate on women at high-risk for breast cancer, at the level of immunosurveillance and mammary epithelial cell differentiation.

Condition Intervention Phase
Breast Neoplasms
Drug: Alendronate
Phase 1

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Pilot Clinical Trial of Short-Term Bisphosphonate Administration as Chemoprevention for Breast Cancer Via Engagement of γδ T Cells

Resource links provided by NLM:


Further study details as provided by University of Wisconsin, Madison:

Primary Outcome Measures:
  • Percentage change of γδ T cell in CNB [ Time Frame: 1-3 weeks ] [ Designated as safety issue: No ]
    γδ T cell infiltration and activation as defined by the presence and increase in percentage of γδ T cells in the CNB sample following study agent (alendronate) administration. The effect of alendronate will be assessed using a one-tailed one-sample paired t-test or Wilcoxon signed rank test at a significance level of 0.10.


Secondary Outcome Measures:
  • Percentage change of mammary epithelial basal and luminal cells in the CNB samples after alendronate administration [ Time Frame: 1-3 weeks ] [ Designated as safety issue: No ]
    The effect of alendronate will be assessed using a one-tailed one-sample paired t-test or Wilcoxon signed rank test at a significance level of 0.10.


Other Outcome Measures:
  • Percentage change of γδ T cells in the blood [ Time Frame: 1-3 weeks ] [ Designated as safety issue: No ]
    The effect of alendronate will be assessed using a one-tailed one-sample paired t-test or Wilcoxon signed rank test at a significance level of 0.10.

  • Ratio of percent of luminal cells to percent of basal cells in CNB [ Time Frame: 1-3 weeks ] [ Designated as safety issue: No ]
    The effect of alendronate will be assessed using a one-tailed one-sample paired t-test or Wilcoxon signed rank test at a significance level of 0.10.


Estimated Enrollment: 20
Study Start Date: June 2016
Estimated Primary Completion Date: January 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Alendronate
Subjects will take the study drug alendronate, a nitrogenous bisphosponate, for approximately one to three weeks before their breast surgery.
Drug: Alendronate
10 mg (1 tablet) once daily for 1-3 weeks before breast surgery; drug will be discontinued the day before surgery.
Other Names:
  • Fosamax
  • Binosto

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Patients referred for risk reduction mastectomy (ex. BRCA or other high-risk gene mutations, strong family history of breast cancer, history of LCIS, ADH, ALH and those with DCIS undergoing bilateral mastectomy or prophylactic contralateral mastectomy)
  • Patients who are premenopausal defined as an individual with at least six menstrual cycles in the past year
  • Patients must be 18 years of age or older
  • The effects of Alendronate on the developing fetus are unknown. For this reason, heterosexual women must agree to use TWO effective forms of birth control for the duration of study participation and for 8 weeks following the last dose of study medication. Women must combine a hormonal birth control method (e.g. combined oral contraceptive pill, vaginal ring, skin patch, injection, or copper IUD) in continuous use for >90 days prior to study entry (except in the case of a copper IUD), with a non-hormonal birth control method (e.g. diaphragm, cervical cap, cervical shield with spermicide, contraceptive sponge, or condom (male or female) with spermicide).
  • Women with hysterectomy with intact functioning ovaries, women with Fallopian tubes cut, tied, or sealed, and women with a sterilization implant (e.g. Adiana, Essure) placed >3 months prior to beginning the study drug are not considered to be able to bear children and therefore are eligible to participate without the use of concurrent birth control.
  • Females of child-bearing potential must have a negative pregnancy test within the current menstrual cycle and within 7 days before starting drug.
  • Patients must have recovered from major infections and/or surgical procedures, and in the opinion of the investigator, not have any significant active concurrent medical illnesses precluding protocol treatment
  • Participants must have the ability to understand, and the willingness to sign, a written informed consent form

Exclusion Criteria:

  • Patients with a previous diagnosis of invasive breast cancer
  • Patients who are post-menopausal (defined as 12 consecutive months without a menstrual period).
  • Patients with an implant in the sampled breast
  • Pregnant or lactating women are excluded from this study. Breastfeeding must be discontinued for the duration of study participation and for 8 weeks after the last dose of the study agent
  • Patients for whom English is not their native language
  • Patients with current or previous bisphosphonate therapy
  • Patients with a history of allergic reactions attributed to compounds of similar chemical or biologic composition of alendronate and other bisphosphonates.
  • Patients with esophageal dysmotility
  • Patients unable to sit up or stay up for 30 minutes after taking oral dose
  • Patients who have taken non-steroidal anti-inflammatory drugs (NSAIDs) in the past two weeks
  • Patients who have received chemotherapy for a malignancy in the past 5 years
  • Patients who are treated for a medical condition (such as ulcerative colitis) with chronic steroids during the 2 years prior to planned mastectomy surgery
  • Patients with calculated creatinine clearance (Cockroft-Gault) less than 35 mL/min
  • Patients with a history of hypocalcemia
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02781805

Contacts
Contact: Cancer Connect 800-622-8922 cancerconnect@uwcarbone.wisc.edu

Locations
United States, Wisconsin
University of Wisconsin Carbone Cancer Center Not yet recruiting
Madison, Wisconsin, United States, 53705
Contact: Cancer Connect    800-622-8922    cancerconnect@uwcarbone.wisc.edu   
Principal Investigator: Lee Wilke         
Sponsors and Collaborators
University of Wisconsin, Madison
National Cancer Institute (NCI)
Wisconsin Partnership Program
Investigators
Principal Investigator: Lee Wilke University of Wisconsin, Madison
  More Information

Additional Information:
Responsible Party: University of Wisconsin, Madison
ClinicalTrials.gov Identifier: NCT02781805     History of Changes
Other Study ID Numbers: UW13060  P30CA014520  2016-0322 
Study First Received: May 20, 2016
Last Updated: May 20, 2016
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Breast Neoplasms
Breast Diseases
Neoplasms
Neoplasms by Site
Skin Diseases
Alendronate
Diphosphonates
Bone Density Conservation Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on May 23, 2016