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Denosumab and Mammographic Density in Premenopausal Women With Dense Breasts (TRIDENT)

Denosumab and Mammographic Density in Premenopausal Women With Dense Breasts (TRIDENT)

Clinicaltrials.gov identifier:
NCT04067726

Prevention:
Breast

Study Contact Information:

Contact: Ava Weibman by phone: 314-747-9992 or by email.
Contact: Ava Weibman by phone: 314-747-9992 or by email.
PI: Adetunji Toriola – 314-286-2668 or by email
 

 


RANKL Inhibition With Denosumab on Mammographic Density in Premenopausal Women With Dense Breasts (TRIDENT)

About the Study

The purpose of this study is to evaluate if denosumab can reduce the breast density of premenopausal women who have dense breasts. Denosumab is an FDA-approved injectable medication that is used to treat osteoporosis and to prevent fractures in cancer patients with bone metastases. This study could help us identify novel ways to prevent breast cancer in younger women.

Type of Study

This is a randomized, 2-arm study to evaluate the effects of denosumab on breast density in women with dense breasts. You will be randomly assigned (meaning by chance or like tossing a coin) to one of two groups. Neither you nor your doctor will decide which group you are in.

The study has two arms. This means that patients in the study are placed in one of two different groups. 

  • Group 1 (denosumab): participants in this group will receive two injections of denosumab. One at the beginning of the study and the second dose six months later. 
  • Group 2 (no denosumab): participants will receive two injections of placebo, one at the beginning of the study and the second six months later. 

What the Study Entails

You will be randomly assigned to one of two groups.

  • Group 1 (denosumab): 2 injections of denosumab received right under the skin in the upper arm
  • Group 2 (placebo): 2 injections of saline received right under the skin in the upper arm. This group will provide baseline measurements that will be compared to the denosumab group. The placebo is essential for ensuring that any effects of denosumab are caused by the drug and not another factor.

For women in both groups, Group 1 (denosumab) and Group 2 (saline), you will:

  • Continue your routine mammograms at baseline, 12 months and 24 months (allowing the study team access to your mammogram images).
  • Complete a survey that should take no longer than 30 minutes
  • Complete a urine pregnancy test at baseline and 6 months
  • Have your blood drawn at baseline, 6 months, and 12 months
  • Receive a breast biopsy at baseline and 12 months
  • Receive an injection of denosumab or the placebo (saline) at baseline and 6 months
  • Take oral calcium and vitamin D supplements provided by the research team for one year

Study Location:

Washington University School of Medicine
St. Louis, MO
Contact: Ava Weibman by phone: 314-747-9992 or by email.

This Study is Open To:

Women can participate if they:

  • Are premenopausal women age 40 years or older.
  • Have dense breasts.
  • This research study is seeking participants who have a known or suspected inherited mutation linked to a higher risk of breast cancer other than BRCA1 or BRCA2. This may include ATM, PALB2, PTEN, CDH1 or other mutations. 
This Study is Not Open To:
  • Women who have a history of cancer.
  • Women who have a history of osteoporosis.
  • Women who have an inherited BRCA1 or BRCA2 mutation.