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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
2,273 Previous Clinical Trials
14,840,362 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

Frequently Asked Questions

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

Is there an age limit for applicants to this medical experiment?

"All applicants for this medical trial need to be aged between 18 and 90. There are 85 sub-18 year old trials available and 2680 studies targeting those over 65 years of age."

Answered by AI

Is there capacity for more participants to join this clinical research?

"Unfortunately, this trial is no longer in search for participants. It was initially posted on February 20th 2019 and modified on November 11th 2022. A number of other studies are still enrolling patients with breast cancer (2596) as well as 204 trials associated with Blueprint that remain open to potential volunteers."

Answered by AI

Can I become a participant in this experiment?

"30 suitable candidates, aged 18 to 90 and presenting with breast cancer, are being sought for enrollment. Criteria include: never having received treatment; displaying histologically confirmed invasive ductal carcinoma between stages 1-3; co-enrollment in the FLEX Registry; ER+/PR+ hormone receptor statuses defined by immunohistochemistry (IHC); capability of comprehending their condition and giving informed consent."

Answered by AI

What other investigative studies have been conducted concerning Blueprint's efficacy?

"Currently there are 204 clinical trials delving into Blueprint, with 57 of them in the final phase. Most of these experiments take place in San Francisco but can be found at 13123 sites around America."

Answered by AI

For what maladies is Blueprint typically utilized?

"Blueprint is a proven treatment for polycystic ovary syndrome and can additionally be beneficial in managing breast cancer, post-breast surgery recovery, and other mammary complications."

Answered by AI

What is the primary objective of this medical experiment?

"The primary goal of this research, which will be evaluated at Baseline and up to 6 weeks post-surgery, is the alteration in Ki67 expression as assessed by immunohistochemistry. Secondary objectives include an evaluation of Mammaprint risk report (high or low chance of recurrence), single gene read out measuring Estrogen Receptor protein concentrations (>10% for positive/ <1% for negative) , as well as Estrogen Receptor protein amounts using Immunohistochemistry."

Answered by AI

What potential hazards might patients be exposed to when taking Blueprint?

"Although there is a collection of data indicating the safety of Blueprint, no evidence exists to confirm its efficacy. As such, it received a rating 2 on our team's scale from 1 to 3."

Answered by AI

What is the accepted participant capacity of this experiment?

"This clinical trial has concluded its recruitment period. First posted on February 20th 2019, the study was last updated November 11th 2022. If you are seeking other studies, 2596 trials for breast cancer and 204 Blueprint related ones presently require participants."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
The Effects of Short-term Preoperative Treatment With Hormonal Therapy on Gene Profiles in Breast Cancer
2019. "The Effects of Short-term Preoperative Treatment With Hormonal Therapy on Gene Profiles in Breast Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04129216.
~5 spots leftby May 2025
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