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Denosumab for Breast Cancer

Phase-Based Progress Estimates
2
Effectiveness
3
Safety
University of Colorado Hospital, Aurora, COBreast Cancer+5 MoreDenosumab - Drug
Eligibility
25 - 55
Female
What conditions do you have?
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Study Summary

This trial is testing whether denosumab can prevent breast cancer in women with a BRCA1 gene mutation, which is linked to a higher risk of developing the disease.

Eligible Conditions
  • Breast Cancer
  • Tumors
  • BRCA1 Mutations
  • Breast Disease

Treatment Effectiveness

Effectiveness Progress

2 of 3
This is further along than 85% of similar trials

Similar Trials

1
Vitamin D
1
Pembrolizumab
1
PDC-1421 Capsule

Study Objectives

1 Primary · 8 Secondary · Reporting Duration: Up to 5 years post treatment

Year 5
Time to the occurrence of any breast cancer (invasive or ductal carcinoma in situ [DCIS])
Year 5
Assess incidence, nature and severity of adverse events (AEs) using the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0
Frequency of benign breast lesions
Frequency of breast biopsies
Time to clinical fractures in pre- and postmenopausal women
Time to invasive breast cancer
Time to invasive triple negative breast cancer
Time to other (nonbreast or ovarian cancer) malignancies, including those known to be associated with BRCA1 mutations
Time to ovarian, fallopian and peritoneal cancer (in women who have not undergone prophylactic bilateral salpingo-oophorectomy)

Trial Safety

Safety Progress

3 of 3
This is further along than 85% of similar trials

Similar Trials

1
Vitamin D
1
Pembrolizumab
2
PDC-1421 Capsule

Side Effects for

Teriparatide
30%Contusion
15%Arthralgia
12%Nausea
12%Fatigue
12%Headache
9%Pain in extremity
9%Cough
9%Bronchitis
6%Local swelling
6%Hypokalaemia
6%Dysgeusia
6%Urine abnormality
6%Rash
3%Abdominal pain
3%Bladder spasm
3%Injection site erythema
3%Muscular weakness
3%Nephrolithiasis
3%Sneezing
3%Gastrooesophageal reflux disease
3%Nasopharyngitis
3%Joint stiffness
3%Post procedural discomfort
3%Dizziness
3%Lung adenocarcinoma
3%Spider vein
3%Chest pain
3%Ear infection
3%Abdominal discomfort
3%Groin pain
3%Basal cell carcinoma
3%Constipation
3%Diarrhoea
3%Fall
3%Tremor
3%Hypotension
3%Abdominal pain lower
3%Bone pain
3%Joint swelling
3%Sensation of heaviness
3%Tendon disorder
3%Thirst
3%Lymph node pain
3%Dry eye
3%Gastroenteritis
3%Foot deformity
3%Loss of consciousness
3%Oropharyngeal pain
3%Vaginal discharge
3%Chronic obstructive pulmonary disease
3%Alopecia
3%Hyperhidrosis
3%Onychoclasis
3%Pruritus
3%Skin induration
3%Swelling face
3%Urticaria
3%Haematoma
This histogram enumerates side effects from a completed 2014 Phase 4 trial (NCT01753856) in the Teriparatide ARM group. Side effects include: Contusion with 30%, Arthralgia with 15%, Nausea with 12%, Fatigue with 12%, Headache with 12%.

Trial Design

2 Treatment Groups

Arm A (denosumab)
1 of 2
Arm B (placebo)
1 of 2

Experimental Treatment

Non-Treatment Group

300 Total Participants · 2 Treatment Groups

Primary Treatment: Denosumab · Has Placebo Group · Phase 3

Arm A (denosumab)Experimental Group · 2 Interventions: Denosumab, Quality-of-Life Assessment · Intervention Types: Drug, Other
Arm B (placebo)PlaceboComparator Group · 2 Interventions: Placebo, Quality-of-Life Assessment · Intervention Types: Drug, Other
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Denosumab
FDA approved

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: up to 5 years post treatment

Who is running the clinical trial?

Alliance for Clinical Trials in OncologyLead Sponsor
506 Previous Clinical Trials
217,170 Total Patients Enrolled
74 Trials studying Breast Cancer
39,843 Patients Enrolled for Breast Cancer
National Cancer Institute (NCI)NIH
13,162 Previous Clinical Trials
41,166,895 Total Patients Enrolled
927 Trials studying Breast Cancer
1,536,521 Patients Enrolled for Breast Cancer
Austrian Breast & Colorectal Cancer Study Group (ABCSG)UNKNOWN
Judy E. Garber, MD, MPHStudy ChairDana-Farber Cancer Institute

Eligibility Criteria

Age 25 - 55 · Female Participants · 8 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
Rewritten Criterion: You do not plan on having any surgery to prevent breast cancer at the time of the study.
References

Frequently Asked Questions

Can young adults participate in this research?

"The age criteria to participate in this study is being 25 years or older, and 55 years or younger." - Anonymous Online Contributor

Unverified Answer

Are you looking for participants for this clinical research right now?

"Yes, this is accurate. The website clinicaltrials.gov has information indicating that the study is still looking for participants. The trial was posted on February 23rd, 2022 and was updated most recently on August 1st, 2022." - Anonymous Online Contributor

Unverified Answer

Can you share some other instances where Denosumab has been used in research?

"Denosumab was first studied in 2014 at Hirslanden Klinik Aarau. So far, 18438 studies have completed. Right now, there are 49 trials recruiting patients, with a large portion of these based out of Englewood, Minnesota." - Anonymous Online Contributor

Unverified Answer

How many patients are being enrolled in this experiment?

"This study requires the recruitment of 300 individuals that satisfy the pre-determined inclusion criteria. Patients have the opportunity to participate at one of many locations, such as Mountain Blue Cancer Care Center - Swedish in Englewood, Minnesota or Mayo Clinic in Rochester in Rochester, Illinois." - Anonymous Online Contributor

Unverified Answer

How is Denosumab most often employed?

"Denosumab is the go-to medication for treating bone and bones. Additionally, it can be used to ameliorate skeletally mature, androgens, and malignant neoplasms." - Anonymous Online Contributor

Unverified Answer

Who meets the criteria to participate in this experiment?

"This clinical trial is testing a breast cancer treatment that is only effective for patients between the ages of 25 and 55. Out of the 300 patients that will be enrolled in the study, some will receive the experimental medication while others will not." - Anonymous Online Contributor

Unverified Answer

Are there any serious risks associated with Denosumab?

"There is some data supporting the efficacy of Denosumab, and it has been through multiple rounds of testing, so our team at Power rates its safety as a 3." - Anonymous Online Contributor

Unverified Answer

In how many different places can people participate in this research project?

"There are a total of 24 sites for this study, with 12 locations in the United States of America and 12 in other countries." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

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