Breast NeoplasmsPhase 1NCT02781805
Pilot Study of Bisphosphonates for Breast Cancer
A Phase 1 study testing Alendronate in people with Breast Neoplasms, run by University of Wisconsin, Madison at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Breast Neoplasms
- What is being tested?
- Alendronate
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Aug 2016to 12 Dec 2018
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients referred for risk reduction mastectomy (eg. BRCA or other high-risk gene mutations, strong family history of breast cancer, prior or current LCIS, ADH, ALH and DCIS undergoing bilateral mastectomy or prophylactic contralateral mastectomy), oe patients at high-risk for breast cancer (eg. BRCA or other high-risk gene mutations, strong family history of breast cancer, prior or current 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.
- Patients must be 18 years of age or older
- The effects of Alendronate on the developing fetus are unknown. For this reason, 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. One of the following methods of birth control must be used by sexually active women of childbearing potential:
- Oral contraceptive pill in continuous use for >90 days prior to study entry
- Vaginal ring in continuous use for >90 days prior to study entry
Show all 18Show fewer
- Skin patch in continuous use for >90 days prior to study entry
- Injection in continuous use prior to study entry
- IUD
- Diaphragm, cervical cap, or cervical shield with spermicide
- Contraceptive sponge
- Condom (male or female type) plus spermicide
- Male partner who has had a vasectomy
- Women who are abstinent from heterosexual encounters for the duration of the study participation and for the 56 days following the last dose of study medication will not be required to uses birth control.
- 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
Who cannot join
- 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
Show all 15Show fewer
- 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 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
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Wisconsin Carbone Cancer Center
Madison, Wisconsin, 53705
About this study
Official title: Pilot Clinical Trial of Short-Term Bisphosphonate Administration as Chemoprevention for Breast Cancer Via Engagement of γδ T Cells
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
- Being tested
- Alendronate
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AlendronateDrug
Also called Fosamax, Binosto
10 mg (1 tablet) once daily for 1-3 weeks before breast surgery; drug will be discontinued the day before surgery.
| Study group | Role | What they receive |
|---|---|---|
| Alendronate | Experimental | Subjects will take the study drug alendronate, a nitrogenous bisphosponate, for approximately one to three weeks before their breast surgery. Receives: Drug: Alendronate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage change of γδ T cell in CNB
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.
Measured: 1-3 weeks
Secondary outcomes (2)
Percentage change of mammary epithelial basal cells in the CNB samples after 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.
Measured: 1-3 weeks
Percentage change of mammary luminal cells in the CNB samples after 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.
Measured: 1-3 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 May 2016 (estimated)
- Study start5 Aug 2016
- Primary completion12 Dec 2018
- Study completion12 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast NeoplasmsStudies of the same condition, open and under way.
- More trials run by University of Wisconsin, MadisonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Wisconsin, Madison
- Sponsor type
- University, hospital or other
- Collaborators
- Wisconsin Partnership Program
- Responsible party
- Sponsor
- Investigators
- Lee Wilke, Principal investigator, University of Wisconsin, Madison
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02781805
- Sponsor's protocol ID
- UW13060
- Other IDs
- 2016-0322, A539997, SMPH\VOLUNTEER STAFF\SURGERY, NCI-2016-00786
- Status last verified
- Apr 2020
- First submitted
- 20 May 2016
- Last updated
- 22 Oct 2020
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 22 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Clinical Trial of Short-Term Bisphosphonate Administration as Chemoprevention for Breast Cancer Via Engagement of γδ T Cells
- ClinicalTrials.gov ID
- NCT02781805
- Acronym / sponsor ID
- UW13060
- Conditions
- Breast Neoplasms
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 6 participants (actual)
- Lead sponsor
- University of Wisconsin, MadisonUniversity, hospital or other
- Collaborators
- Wisconsin Partnership Program
- Study start
- 5 Aug 2016 (actual)
- Primary completion
- 12 Dec 2018 (actual)
- Study completion
- 12 Dec 2018 (actual)
- First posted
- 24 May 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Alendronate | Experimental | Drug: AlendronateSubjects will take the study drug alendronate, a nitrogenous bisphosponate, for approximately one to three weeks before their breast surgery. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (18 listed)
- Patients referred for risk reduction mastectomy (eg. BRCA or other high-risk gene mutations, strong family history of breast cancer, prior or current LCIS, ADH, ALH and DCIS undergoing bilateral mastectomy or prophylactic contralateral mastectomy), oe patients at high-risk for breast cancer (eg. BRCA or other high-risk gene mutations, strong family history of breast cancer, prior or current 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.
- Patients must be 18 years of age or older
- The effects of Alendronate on the developing fetus are unknown. For this reason, 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. One of the following methods of birth control must be used by sexually active women of childbearing potential:
- Women who are abstinent from heterosexual encounters for the duration of the study participation and for the 56 days following the last dose of study medication will not be required to uses birth control.
Key exclusion criteria (15 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AlendronateAlso: Fosamax, Binosto10 mg (1 tablet) once daily for 1-3 weeks before breast surgery; drug will be discontinued the day before surgery. | Drug | Alendronate |
Primary outcome
Percentage change of γδ T cell in CNB
Time frame: 1-3 weeks
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.
2 secondary outcomes
Percentage change of mammary epithelial basal cells in the CNB samples after alendronate administration
Time frame: 1-3 weeks
Percentage change of mammary luminal cells in the CNB samples after alendronate administration
Time frame: 1-3 weeks
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Oct 2020.
- UW Carbone Cancer Center Home PageLink provided by the sponsor.
Related trials for Breast Neoplasms
Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions
RecruitingPhase 2
Gene Signatures to Guide HR+MBC Therapy in a Diverse Cohort
Invasive Mammary Carcinoma, Metastatic Breast Cancer
Not yet recruitingObservational study
Comparison of Reliability, Time Cost, and Participant Comfort of Lymphedema Assessments in Upper Extremity
Lymphedema, Upper Extremity Lymphedema
RecruitingPhase 3
A Study of Camrelizumab Plus Chemotherapy in Combination With or Without Famitinib as Neoadjuvant Therapy in Participants With Triple Negative Breast Cancer (BCTOP-T-N01)
TNBC - Triple-Negative Breast Cancer
RecruitingPhase 3
Testing Whether Hormone Therapy With Ribociclib is as Effective as Chemotherapy Followed by Hormone Therapy With Ribociclib for the Treatment of High Anatomic Stage Breast Cancer With Low Recurrence Risk, The RxFINE-Low Trial
Anatomic Stage II Breast Cancer AJCC v8, Anatomic Stage IIIA Breast Cancer AJCC v8
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lee Wilke principal investigator
University of Wisconsin, Madison
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Alendronate in people with Breast Neoplasms, run by University of Wisconsin, Madison at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 18 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 22 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early. Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage change of γδ T cell in CNB (time frame: 1-3 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Oct 2020; AzTrials last refreshed its copy on 7 Nov 2026.