Alendronate Sodium in Preventing Breast Cancer in Premenopausal Patients Undergoing Risk-Reduction Surgery

Status: Active

Description

This pilot phase I clinical trial studies how well alendronate sodium works in preventing breast cancer in premenopausal patients that have high risk gene mutations and are undergoing surgery to reduce the risk of breast cancer or are undergoing routine surveillance or are willing to undergo two clinic biopsies. Alendronate sodium may increase the number and activity of special immune cells that are able to kill new tumor cells in breast tissue.

Eligibility Criteria

Inclusion Criteria

  • Patients referred for risk reduction mastectomy (eg. BRCA or other high-risk gene mutations, strong family history of breast cancer, prior or current lobular breast carcinoma in situ (LCIS), atypical ductal breast hyperplasia (ADH), atypical lobular breast hyperplasia (ALH) and ductal breast carcinoma in situ (DCIS) undergoing bilateral mastectomy or prophylactic contralateral mastectomy); also, patients at high-risk for breast cancer (eg. BRCA or other high-risk gene mutations, strong family history of breast cancer, prior or current of LCIS, ADH, ALH and DCIS) who are not planning for immediate risk reduction mastectomy and are undergoing routine follow up
  • Patients who are premenopausal defined as an individual with at least six menstrual cycles in the past year * Women with hysterectomy with intact functioning ovaries who are not having menstrual cycles need to be 45 years of age and under
  • Breast surgeons may recommend that this patient population should not take any oral contraceptives or hormone eluting intrauterine devices (IUDs); sexually active heterosexual women must agree to use an effective form of birth control for the duration of study participation; women who are NOT having 1) a hysterectomy, 2) fallopian tubes removed and/or 3) ovaries removed at the time of their breast surgery will also be required to use an effective form of birth control for 56 days following the last dose of study medication; in addition to, premenopausal women who are undergoing routine follow up and are not having surgery will be required to use an effective form of birth control for 56 days following the last dose of study medication * The following women are not considered able to bear children and therefore are eligible to participate without the use of concurrent birth control: ** Female with hysterectomy with intact functioning ovaries ** Female with fallopian tubes cut, tied, sealed, or removed ** Female with sterilization implant (e.g. Adiana, Essure) place > 3 months prior to beginning study drug * One of the following methods of birth control must be used by sexually active women of childbearing potential for the duration of study participation and for 56 days following the last dose of study medication: ** Oral contraceptive pill in continuous use for > 90 days prior to study entry ** Vaginal ring (e.g.NuvaRing) in continuous use for > 90 days prior to study entry ** Skin patch (e.g. Ortho Evra) in continuous use for > 90 days prior to study entry ** Injection (e.g. Depo-Proveera, Noristerat) in continuous use prior to study entry ** IUD ** Diaphragm, cervical cap, or cervical shield with spermicide ** Contraceptive sponge (e.g. Today Sponge) ** Condom (male or female type) plus spermicide ** Male partner who has had a vasectomy * Women who indicate that they are abstinent from heterosexual encounters for the duration of study participation and for the 56 days following the last dose of study medication will not be required to use 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 who are less than 3 years from diagnosis
  • Patients currently on endocrine therapy (tamoxifen, ralozifene or an aromatase inhibitor)
  • 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 56 days after the last dose of the study agent
  • Patients who do not speak or understand English
  • 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
  • Patient 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 within the last 2 years
  • Patients with calculated creatinine clearance (Cockroft-Gault) less than 35 mL/min
  • Patients with a history of hypocalcemia
  • Bilateral DCIS, LCIS, ADH or ALH

Locations & Contacts

Wisconsin

Madison
University of Wisconsin Hospital and Clinics
Status: Active
Contact: Lee Gravatt Wilke
Phone: 608-265-5852
Email: wilke@surgery.wisc.edu

Trial Objectives and Outline

PRIMARY OBJECTIVES:

I. To investigate the hypothesis that bisphosphonates may have chemopreventive action in breast cancer via activation of gamma-delta T cells.

OUTLINE:

Patients receive alendronate sodium orally (PO) once daily (QD) for 1-3 weeks before breast surgery or up to 5 weeks if surgery is delayed.

After completion of study treatment, patients are followed up at 7-14 days.

Trial Phase & Type

Trial Phase

Phase I

Trial Type

Prevention

Lead Organization

Lead Organization
University of Wisconsin Hospital and Clinics

Principal Investigator
Lee Gravatt Wilke

Trial IDs

Primary ID UW13060
Secondary IDs NCI-2016-00786, 2016-0322
Clinicaltrials.gov ID NCT02781805