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Hormone Therapy

quality-of-life assessment for Breast Cancer

City of Hope Comprehensive Cancer Center, Duarte, CA
Targeting 3 different conditionsquality-of-life assessment +6 morePhase 2Waitlist AvailableLed by Jeffrey Weitzel, MDResearch Sponsored by City of Hope Medical Center

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
  • BRCA2 Mutation

Eligibility Criteria

Inclusion Criteria

You will be eligible if you check “Yes” for the criteria below
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You have a gene mutation called BRCA that increases your risk of breast cancer, or your estimated lifetime risk of breast cancer is more than 30% according to a special calculation.
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You should not be smoking at the moment.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
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
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

Awards & Highlights

Approved for 10 Other Conditions
This treatment demonstrated efficacy for 10 other conditions.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Group 1 (planned risk reduction mastectomy)Experimental Treatment6 Interventions
Patients receive deslorelin, estradiol, and testosterone intranasally QD for 6 months. Patients then undergo planned risk reduction mastectomy.
Group II: Group 2 (continued survaillance)Active Control6 Interventions
Patients receive deslorelin, estradiol, and testosterone intranasally QD for 10 months. Patients then undergo continued surveillance through 10 months.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Estradiol
FDA approved
Testosterone
FDA approved
therapeutic conventional surgery
2003
Completed Phase 3
~12270
quality-of-life assessment
2012
Completed Phase 3
~2780

Find a site

Who is running the clinical trial?

City of Hope Medical CenterLead Sponsor
544 Previous Clinical Trials
2,251,968 Total Patients Enrolled
42 Trials studying Breast Cancer
6,638 Patients Enrolled for Breast Cancer
National Cancer Institute (NCI)NIH
13,402 Previous Clinical Trials
41,225,330 Total Patients Enrolled
929 Trials studying Breast Cancer
1,540,014 Patients Enrolled for Breast Cancer
Jeffrey Weitzel, MDPrincipal Investigator
City of Hope Medical Center

Media Library

Deslorelin (Hormone Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT00080756 — Phase 2
Breast Cancer Research Study Groups: Group 1 (planned risk reduction mastectomy), Group 2 (continued survaillance)
Breast Cancer Clinical Trial 2023: Deslorelin Highlights & Side Effects. Trial Name: NCT00080756 — Phase 2
Deslorelin (Hormone Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT00080756 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

To whom is this trial open? Who meets the qualifications for enrollment in this experiment?

"The ideal participants for this trial are female, between 21 and 48 years old, and have a breast cancer diagnosis. So far, 11 people have been accepted into the study."

Answered by AI

Does the FDA condone using laboratory biomarker analysis as a method?

"There is some data to support the safety of laboratory biomarker analysis, but none yet for efficacy. We rank it as a 2."

Answered by AI

Are there any age restrictions for participants in this clinical trial?

"The age requirements for this clinical trial are that potential participants must be 21 years old or younger and 48 years old or younger."

Answered by AI

Are there any open slots for new participants in this research project?

"At this moment, this clinical trial is not enrolling patients. Although, it was first posted 18 years ago on March 11th, 2004 and edited more recently on September 26th, 2022. There are presently 2698 trials actively admitting patients with breast cancer and 82 trials for laboratory biomarker analysis searching for participants."

Answered by AI

How many individuals are being asked to participate in this research project?

"This study is not recruiting at this moment. The trial was first advertised on March 11th, 2004 and was last updated September 26th, 2022. However, there are presently 2698 trials actively enrolling participants with breast cancer and 82 studies for laboratory biomarker analysis actively enrolling participants."

Answered by AI

What conditions can be diagnosed through laboratory biomarker analysis?

"hypogonadism, advanced androgen dependent prostate cancer, and amenorrhea can all be diagnosed and treated by laboratory biomarker analysis."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Deslorelin Combined With Low-Dose Add-Back Estradiol and Testosterone in Preventing Breast Cancer in Premenopausal Women Who Are at High Risk for This Disease
2004. "Deslorelin Combined With Low-Dose Add-Back Estradiol and Testosterone in Preventing Breast Cancer in Premenopausal Women Who Are at High Risk for This Disease". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT00080756.
~0 spots leftby Dec 2023
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