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Hormonal Therapy for Breast Cancer

Phase 2
Waitlist Available
Led By Mehran Habibi, MD
Research Sponsored by Johns Hopkins University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline and at time of surgery (up to 6 weeks)
Awards & highlights

Study Summary

This trial will study the effects of a short-term hormone therapy on the genes and molecules of breast cancer patients.

Eligible Conditions
  • Breast Cancer

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline and at time of surgery (up to 6 weeks)
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline and at time of surgery (up to 6 weeks) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in Percent Expression of Ki67 Measured by Immunohistochemistry (IHC)
Secondary outcome measures
Median Percent of Tissue ER Positive
Median Percent of Tissue PR Positive
Number of Participants With Low or High Score in MammaPrint

Trial Design

3Treatment groups
Experimental Treatment
Group I: Tamoxifen armExperimental Treatment3 Interventions
for premenopausal patients
Group II: Letrozole armExperimental Treatment3 Interventions
for postmenopausal patients
Group III: Exemestane armExperimental Treatment3 Interventions
for postmenopausal patients
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Exemestane
2003
Completed Phase 4
~7630
Blueprint
2019
Completed Phase 2
~30
Tamoxifen Citrate
2011
Completed Phase 3
~3780
Letrozole
2002
Completed Phase 4
~2770
Mammaprint
2019
Completed Phase 2
~30

Find a Location

Who is running the clinical trial?

AgendiaIndustry Sponsor
17 Previous Clinical Trials
39,090 Total Patients Enrolled
8 Trials studying Breast Cancer
34,699 Patients Enrolled for Breast Cancer
Johns Hopkins UniversityLead Sponsor
2,274 Previous Clinical Trials
14,840,487 Total Patients Enrolled
27 Trials studying Breast Cancer
23,464 Patients Enrolled for Breast Cancer
Mehran Habibi, MDPrincipal InvestigatorJohns Hopkins Bayview
2 Previous Clinical Trials
34 Total Patients Enrolled
2 Trials studying Breast Cancer
34 Patients Enrolled for Breast Cancer

Media Library

Blueprint Clinical Trial Eligibility Overview. Trial Name: NCT04129216 — Phase 2
Breast Cancer Research Study Groups: Exemestane arm, Tamoxifen arm, Letrozole arm
Breast Cancer Clinical Trial 2023: Blueprint Highlights & Side Effects. Trial Name: NCT04129216 — Phase 2
Blueprint 2023 Treatment Timeline for Medical Study. Trial Name: NCT04129216 — Phase 2
~5 spots leftby Jun 2025
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