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Hormone Therapy
Giredestrant for Endometrial Cancer (EndomERA Trial)
Phase 2
Recruiting
Research Sponsored by Hoffmann-La Roche
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
No prior treatment for endometrial cancer
Willing to undergo a minimum of 6 continuous cycles of therapy before decision on surgery
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from first regression to first relapse (up to 1 year, 6 months)
Awards & highlights
EndomERA Trial Summary
This trial looks at how safe and effective a new cancer treatment is for endometrial cancer.
Who is the study for?
This trial is for individuals with Grade 1 endometrioid endometrial cancer who haven't had prior treatment and are willing to undergo six cycles of Giredestrant therapy. Participants should have a life expectancy of at least 12 weeks, be able to take oral medications, and have no evidence of deep tumor invasion or disease outside the uterus. Women must agree to avoid pregnancy during the study.Check my eligibility
What is being tested?
The study tests Giredestrant's effectiveness, safety, and how it's processed by the body in patients with early-stage endometrial cancer. It's a global Phase II trial where all participants receive Giredestrant as a single-agent therapy over six cycles before any surgical decision.See study design
What are the potential side effects?
While specific side effects for Giredestrant aren't listed here, common side effects from similar cancer treatments include nausea, fatigue, hormonal changes (like hot flashes), potential blood clots or liver issues. Allergic reactions to medication components can also occur.
EndomERA Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have not received any treatment for endometrial cancer.
Select...
I am willing to undergo at least 6 treatment cycles before considering surgery.
Select...
I can and will take pills.
Select...
I am fully active or can carry out light work.
Select...
I have Grade 1 endometrial cancer and am willing to undergo 6 treatment cycles.
Select...
My MRI shows my cancer has not deeply invaded the muscle layer of my uterus.
EndomERA Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ from first regression to first relapse (up to 1 year, 6 months)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from first regression to first relapse (up to 1 year, 6 months)
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Number of Participants with at Least One Adverse Event, with Severity Determined According to the National Cancer Institute Common Terminology Criteria for Adverse Events, version 5.0 (NCI-CTCAE v5.0)
Percentage of Participants Who Have Regression at 6 Months
Secondary outcome measures
Median Duration of Regression
Median Time to First Regression
Median Time to Relapse or Loss of Clinical Benefit
+2 moreSide effects data
From 2021 Phase 2 trial • 221 Patients • NCT0443674441%
Neutropenia
23%
Neutrophil count decreased
22%
Asthenia
14%
Hot flush
14%
Nausea
13%
Leukopenia
13%
White blood cell count decreased
11%
Arthralgia
11%
Anaemia
9%
Fatigue
8%
Mucosal inflammation
7%
Diarrhoea
5%
Alopecia
5%
Rash
5%
Vomiting
4%
Headache
3%
Constipation
2%
Procedural pain
1%
Aspartate aminotransferase increased
1%
Uterine perforation
1%
Pyrexia
1%
COVID-19
1%
Myocardial infarction
1%
Alanine aminotransferase increased
1%
Hip fracture
100%
80%
60%
40%
20%
0%
Study treatment Arm
Giredestrant + Palbociclib
Anastrozole + Palbociclib
EndomERA Trial Design
1Treatment groups
Experimental Treatment
Group I: GiredestrantExperimental Treatment1 Intervention
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Giredestrant
2019
Completed Phase 2
~300
Find a Location
Who is running the clinical trial?
Hoffmann-La RocheLead Sponsor
2,428 Previous Clinical Trials
1,089,024 Total Patients Enrolled
1 Trials studying Endometrial Cancer
550 Patients Enrolled for Endometrial Cancer
Clinical TrialsStudy DirectorHoffmann-La Roche
2,199 Previous Clinical Trials
888,472 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I haven't taken strong CYP3A4 drugs recently.My blood and organs are functioning well.I don't have any health issues that would make it unsafe for me to try a new drug.My cancer has spread beyond its original location.I have not received cancer treatment in the last 28 days.I am willing and able to follow all study procedures, including biopsies.I have not received any treatment for endometrial cancer.I have heart problems or have had them in the past.I haven't had major surgery in the last 28 days and don't expect to need one during the study.I have not needed IV antibiotics for serious infections in the last 7 days.I can and will take pills.I am willing and able to follow the study's schedule and procedures.My liver disease is moderate to severe.I am fully active or can carry out light work.I do not have any serious health issues that would make it unsafe for me to join the study.My MRI shows my cancer has not deeply invaded the muscle layer of my uterus.I have tested negative for HIV or am stable on HIV treatment.I have a condition that affects my body's ability to absorb nutrients or causes blockage in my intestines.I have a serious heart condition.I am scheduled for surgery during or within 10 days after the study treatment.My cancer is not the common type but one of the rarer forms like serous or clear cell.I have active tuberculosis.I am willing to undergo at least 6 treatment cycles before considering surgery.I have Grade 1 endometrial cancer and am willing to undergo 6 treatment cycles.I haven't had any other cancers in the last 5 years, or if I did, they were not likely to spread or be fatal.
Research Study Groups:
This trial has the following groups:- Group 1: Giredestrant
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What can be said about the potential risks of Giredestrant treatment?
"Based on the available research, our team at Power gave Giredestrant a score of 2 out of 3. This is because it has been evaluated in Phase 2 trials and only data regarding safety have emerged thus far."
Answered by AI
Is there currently an effort to enroll participants in this investigation?
"According to clinicaltrials.gov, this research is currently in the recruitment phase. The trial was published on March 14th of 2023 and has had its most recent update recorded as February 22nd of the same year."
Answered by AI
How many participants are recruited for this clinical research?
"Indeed, the information available on clinicaltrials.gov attests that this trial is still recruiting participants. It was initially listed on March 14th 2023 and has since been revised as of February 22nd 2023. 45 volunteers are needed at a single site for enrollment in this study."
Answered by AI
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