laboratory biomarker analysis for Breast Cancer

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
Breast Cancer+3 More
laboratory biomarker analysis - Other
Eligibility
18 - 65
Female
What conditions do you have?
Select

Study Summary

This trial is studying deslorelin combined with low-dose add-back estradiol and testosterone to see how well it works in preventing breast cancer in premenopausal women who are at high risk for this disease.

Eligible Conditions
  • Breast Cancer
  • brca1 Mutation Carrier
  • BRCA2 protein, human

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

2 Primary · 0 Secondary · Reporting Duration: 2 years

2 years
Perspectives about risk reduction options and their impact on quality of life (QOL) as assessed by Medical Outcomes 36-item short-form version, Health Perceptions scale, and Body Image scale on days 1, 169, and 300, and then every 6 months for 2 years
Day 300
Treatment effects and correlation of changes in morphometrics and biomarkers as assessed by mammogram and magnetic resonance image (MRI) densities on days 1 and 300

Trial Safety

Safety Progress

2 of 3
This is further along than 68% of similar trials

Trial Design

2 Treatment Groups

Group 2 (continued survaillance)
1 of 2
Group 1 (planned risk reduction mastectomy)
1 of 2

Active Control

Experimental Treatment

11 Total Participants · 2 Treatment Groups

Primary Treatment: laboratory biomarker analysis · No Placebo Group · Phase 2

Group 1 (planned risk reduction mastectomy)Experimental Group · 6 Interventions: therapeutic conventional surgery, therapeutic testosterone, therapeutic estradiol, deslorelin, laboratory biomarker analysis, quality-of-life assessment · Intervention Types: Procedure, Drug, Biological, Drug, Other, Procedure
Group 2 (continued survaillance)ActiveComparator Group · 6 Interventions: therapeutic testosterone, therapeutic estradiol, deslorelin, active surveillance, laboratory biomarker analysis, quality-of-life assessment · Intervention Types: Drug, Biological, Drug, Other, Other, Procedure
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
therapeutic conventional surgery
2003
Completed Phase 3
~11930
Testosterone
FDA approved
Estradiol
FDA approved
quality-of-life assessment
2012
Completed Phase 3
~2780

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: 2 years

Who is running the clinical trial?

City of Hope Medical CenterLead Sponsor
505 Previous Clinical Trials
2,247,725 Total Patients Enrolled
42 Trials studying Breast Cancer
6,622 Patients Enrolled for Breast Cancer
National Cancer Institute (NCI)NIH
13,000 Previous Clinical Trials
41,300,896 Total Patients Enrolled
922 Trials studying Breast Cancer
1,535,598 Patients Enrolled for Breast Cancer
Jeffrey Weitzel, MDPrincipal InvestigatorCity of Hope Medical Center

Eligibility Criteria

Age 18 - 65 · Female Participants · 7 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 12th, 2021

Last Reviewed: November 18th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.