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Completed

NCT Number: NCT03629717

RANKL Inhibition and Breast Tissue Biomarkers

A robust knowledge of how to reduce breast density could play a key role in breast cancer prevention in premenopausal women, but viable preventative targets to reduce breast density-associated breast cancer risk are yet to be developed. The investigators propose to investigate the effect of RANKL inhibition with denosumab on breast tissue markers in high-risk premenopausal women with dense breasts. Study findings could provide robust evidence to move forward with a clinical trial targeting RANKL inhibition in premenopausal breast cancer prevention.

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Key information

Conditions

Breast Cancer Prevention Breast Diseases Breast Neoplasms Mammographic Density Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

35 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Early Phase 1

Primary location

Washington University School of Medicine

St Louis, Missouri, 63110, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Female.
  • Premenopausal.
  • At least 35 years of age.
  • Dense breasts on routine mammogram.
  • Willing to take calcium (1,200mg) and vitamin D (800 IU) daily.
  • At increased risk for breast cancer using any of the following:
  • Positive family history of breast cancer
  • Breast cancer risk prediction models
  • Able and willing to return for repeat biopsy.
  • Able to understand and willing to sign an IRB-approved written informed consent document.

Exclusion criteria

  • Current use of tamoxifen, aromatase inhibitors, or bisphosphonates.
  • Concurrently participating in another cancer chemoprevention trial (unless no longer receiving the intervention).
  • Pregnant or lactating.
  • Recent tooth extraction or dental procedure.
  • Unhealed and/or planned dental/oral surgery.
  • History of osteonecrosis/osteomyelitis of the jaw.
  • History of osteoporosis or severe osteopenia.
  • Unable/unwilling to return for repeat biopsy.

Treatment and study plan

Ultrasound-guided core needle biopsy

Procedure

Tissue collection for this research proposal will be used for research purposes only and will not inform participant care

Denosumab

Drug

Denosumab is a human IgG2 monoclonal antibody with affinity and specificity for human RANKL

Other names: Xgeva, Prolia

Blood draw

Procedure

20 mL of fasting whole blood will be collected before denosumab (Day 1) and one month after denosumab administration (day 60 +/- 10 days)

calcium

Drug

1200mg daily

Vitamin D

Drug

800 IU daily

Primary outcomes

  1. Effect of denosumab on breast tissue gene pathway gene expression

    Time frame: Between baseline and day 60

    The investigators will evaluate changes in pathway gene expression between baseline and day 60 using NanoString NCounter platform

  2. Effect of denosumab on pathways that may influence breast cancer development as measured by spatial transcriptomic analysis

    Time frame: Between baseline and day 60

    The investigators will evaluate changes in breast tissue spatial transcriptomics.

  3. Effect of denosumab on pathways that may influence breast cancer development as measured by metabolomic analysis

    Time frame: Between baseline and day 60

    The investigators will evaluate changes in metabolomics.

Secondary outcomes

  1. Correlation of breast tissue gene expression with circulating biomarker levels

    Time frame: 60 days

Sponsors and collaborators

Lead sponsor

Washington University School of Medicine

Other

Registry information

Official study title

RANKL Inhibition and Breast Tissue Biomarkers in Premenopausal Women With Dense Breasts

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
Aug 14, 2018
Registry last updated
Oct 16, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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