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Imlunestrant for Breast Cancer

Phase-Based Progress Estimates
2
Effectiveness
3
Safety
Dicle Üniversitesi, Diyarbakir, TurkeyBreast CancerImlunestrant - Drug
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

This trial is testing whether immunestrant works better than standard hormone therapy for people with early breast cancer who are estrogen receptor positive and human epidermal receptor 2 negative.

Video Summary

Treatment Effectiveness

Effectiveness Progress

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

Similar Trials

1
Patient reported outcomes
1
OP-1250 with Ribociclib
1
Accelerated Partial Breast Irradiation (APBI)

Study Objectives

1 Primary · 7 Secondary · Reporting Duration: Randomization to Death from Any Cause (up to 10 Years)

Year 10
Overall Survival (OS)
Year 10
Distant Recurrence-Free Survival (DRFS)
Year 10
Invasive Disease-Free Survival (IDFS)
Year 5
Change from Baseline in the EORTC QLQ-C30 Global QOL
Change from Baseline in the EORTC QLQ-C30 Role Functioning
Change from Baseline in the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Core Questionnaire (EORTC QLQ-C30) Physical Functioning
Proportion of Time on Study Treatment with High Overall Adverse Event Burden
Year 1
Pharmacokinetics (PK): Steady State Plasma Concentrations of Imlunestrant

Trial Safety

Safety Progress

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

Similar Trials

2
Patient reported outcomes
1
OP-1250 with Ribociclib
2
Accelerated Partial Breast Irradiation (APBI)

Trial Design

2 Treatment Groups

Investigator's Choice of Endocrine Therapy
1 of 2
Imlunestrant
1 of 2

Active Control

Experimental Treatment

6000 Total Participants · 2 Treatment Groups

Primary Treatment: Imlunestrant · No Placebo Group · Phase 3

Imlunestrant
Drug
Experimental Group · 1 Intervention: Imlunestrant · Intervention Types: Drug
Investigator's Choice of Endocrine TherapyActiveComparator Group · 4 Interventions: Tamoxifen, Anastrozole, Letrozole, Exemestane · Intervention Types: Drug, Drug, Drug, Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Imlunestrant
2022
Completed Phase 1
~140

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: randomization to death from any cause (up to 10 years)

Who is running the clinical trial?

Eli Lilly and CompanyLead Sponsor
2,482 Previous Clinical Trials
3,137,146 Total Patients Enrolled
63 Trials studying Breast Cancer
36,818 Patients Enrolled for Breast Cancer
Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)Study DirectorEli Lilly and Company
1,268 Previous Clinical Trials
365,297 Total Patients Enrolled
21 Trials studying Breast Cancer
10,612 Patients Enrolled for Breast Cancer

Eligibility Criteria

Age 18+ · All Participants · 12 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You have received at least 24 months of adjuvant ET, but not more than 60 months.
You have a disease that is associated with an increased risk of disease recurrence.
You have no performance status.

Who else is applying?

How old are they?
18 - 65100.0%
What portion of applicants met pre-screening criteria?
Did not meet criteria100.0%
What state do they live in?
Arizona100.0%
Why did patients apply to this trial?
  • "I was unsure of a couple of questions. My 24 months is coming up in March 2023. I am very interested in this study to see if the medication helps myself, others with breast cancer. I am open to the rules for the trial and can commit to the terms. Thank you,"
How many prior treatments have patients received?
1100.0%
References

Frequently Asked Questions

Can people with the prescribed illness sign up for this test currently?

"That is correct, the public information available on clinicaltrials.gov affirms that this trial is looking for more patients as of 11/9/2022. This particular study was first posted on 10/4/2022 and 100 sites are needed to reach their goal of 6000 participants." - Anonymous Online Contributor

Unverified Answer

How many participants will this research project be able to accommodate?

"That is correct, the information available on clinicaltrials.gov affirms that this study is still looking for volunteers. The trial was first advertised on October 4th of 2020 and has been updated as recently as November 9th, 2020. They are hoping to enroll 6000 individuals from 100 different locations." - Anonymous Online Contributor

Unverified Answer

Has the food and drug administration given Imlunestrant their seal of approval?

"Imlunestrant's safety is based on past clinical trials, and it received a score of 3." - Anonymous Online Contributor

Unverified Answer

Does this research have a broad geographic distribution in North America?

"Banner MD Anderson Cancer Center at McKee Medical Center in Loveland, Colorado, St. Joseph Hospital in Orange, California and Oregon Health and Science University in Portland, Oregon are all running this clinical trial with an additional 100 other medical centres." - 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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