Pilot Study of Bisphosphonates for Breast Cancer

NCT02781805 · Status: TERMINATED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 6

Last updated 2020-10-22

No results posted yet for this study

Summary

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.

Conditions

  • Breast Neoplasms

Interventions

DRUG

Alendronate

10 mg (1 tablet) once daily for 1-3 weeks before breast surgery; drug will be discontinued the day before surgery.

Sponsors & Collaborators

  • Wisconsin Partnership Program

    collaborator OTHER
  • University of Wisconsin, Madison

    lead OTHER

Principal Investigators

  • Lee Wilke · University of Wisconsin, Madison

Study Design

Allocation
NA
Purpose
PREVENTION
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2016-08-05
Primary Completion
2018-12-12
Completion
2018-12-12

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02781805 on ClinicalTrials.gov