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mTOR Inhibitor
Giredestrant + Everolimus for Advanced or Metastatic Breast Cancer
Phase 3
Recruiting
Research Sponsored by Genentech, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Documented estrogen receptor-positive (ER+) tumor and HER2-negative tumor, assessed locally
Eastern Cooperative Oncology Group Performance Status 0-1
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from randomization until death from any cause (up to 42 months)
Awards & highlights
Study Summary
This trial will compare two cancer treatments to see which is more effective in treating breast cancer that is Advanced or has Metastasized and is estrogen receptor and human epidermal growth factor receptor 2 positive.
Who is the study for?
This trial is for adults with advanced breast cancer that's ER-positive, HER2-negative, and has spread. They must have tried CDK4/6 inhibitors and endocrine therapy before. The cancer should be measurable or show bone metastases. Participants need to be relatively healthy (good performance status) and premenopausal women or men must use LHRH agonists.Check my eligibility
What is being tested?
The study compares the effectiveness of Giredestrant plus Everolimus against standard endocrine therapies plus Everolimus in patients who've previously used CDK4/6 inhibitors. It's a Phase III trial where participants are randomly assigned to either treatment group.See study design
What are the potential side effects?
Possible side effects include those common to hormone therapies like hot flashes, fatigue, joint pain, and nausea; as well as specific ones from Everolimus such as mouth sores, rash, diarrhea, decreased blood cell counts increasing infection risk.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My tumor is positive for estrogen receptors and negative for HER2.
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I am fully active or can carry out light work.
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My breast cancer cannot be surgically removed and is not treatable with curative intent.
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I am taking hormone therapy if I am a woman who has not reached menopause or if I am a man.
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My cancer can be measured or seen on scans.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ from randomization until death from any cause (up to 42 months)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from randomization until death from any cause (up to 42 months)
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Progression-Free Survival, as Determined by the Investigator According to RECIST v1.1, in the ESR1m Subpopulation and ITT Population
Secondary outcome measures
Clinical Benefit Rate (CBR), as Determined by the Investigator According to RECIST v1.1, in the ESR1m Subpopulation and ITT Population
Duration of Response (DOR), as Determined by the Investigator According to RECIST v1.1, in the ESR1m Subpopulation and ITT Population
Number of Participants with Clinical Laboratory Test Abnormalities for Biochemistry Parameters Over the Course of the Study
+11 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
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Giredestrant plus EverolimusExperimental Treatment4 Interventions
Group II: Physician's Choice of Endocrine Therapy plus EverolimusActive Control6 Interventions
The physician's choice of endocrine therapy is defined as either exemestane, fulvestrant, or tamoxifen.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Everolimus
2010
Completed Phase 4
~1510
LHRH Agonist
2013
Completed Phase 2
~130
Giredestrant
2019
Completed Phase 2
~300
Find a Location
Who is running the clinical trial?
Genentech, Inc.Lead Sponsor
1,541 Previous Clinical Trials
567,823 Total Patients Enrolled
97 Trials studying Breast Cancer
23,218 Patients Enrolled for Breast Cancer
Clinical TrialsStudy DirectorGenentech, Inc.
2,201 Previous Clinical Trials
888,620 Total Patients Enrolled
138 Trials studying Breast Cancer
72,096 Patients Enrolled for Breast Cancer
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I don't have any serious health issues that would stop me from safely completing the study.I have not had any cancer other than breast cancer in the last 5 years, except for certain low-risk types or those treated with surgery.My tumor is positive for estrogen receptors and negative for HER2.I haven't taken strong CYP3A4 affecting drugs recently.I am fully active or can carry out light work.My cancer has spread to vital organs and poses an immediate risk to my life.I have not taken specific hormone therapies for cancer, except for fulvestrant over 28 days ago or tamoxifen.I have a lung condition that makes it hard to breathe without help.I am sensitive to certain hormone therapies due to my premenopausal or perimenopausal status, or as a man.I haven't had major surgery or cancer treatment in the last 14 days.My breast cancer cannot be surgically removed and is not treatable with curative intent.I am taking hormone therapy if I am a woman who has not reached menopause or if I am a man.I do not have active brain metastases or related conditions.I have a serious liver condition, such as hepatitis, alcohol abuse, or cirrhosis.My breast cancer has worsened after two or more hormone treatments.I have had chemotherapy for cancer that could not be surgically removed or has spread.I have heart problems or have had them in the past.I have received hormone therapy combined with CDK4/6 inhibitors.I can give a blood sample for a specific cancer gene test.My cancer can be measured or seen on scans.I have an active inflammatory bowel condition or have had major GI surgery.I haven't had a serious infection needing antibiotics in the last 2 weeks.
Research Study Groups:
This trial has the following groups:- Group 1: Physician's Choice of Endocrine Therapy plus Everolimus
- Group 2: Giredestrant plus Everolimus
Awards:
This trial has 2 awards, including:- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- 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.
Is this clinical trial still looking for participants?
"That is correct, the online clinicaltrials.gov registry currently has a listing for this trial which was created on 8/3/2022 and updated on 11/1/2022. They are seeking 320 participants which will be spread out over 24 different locations."
Answered by AI
Is Giredestrant known to cause any dangerous side effects?
"Giredestrant is considered safe because it has reached Phase 3 of clinical trials. This means that not only is there some evidence supporting its efficacy, but also that there have been several rounds of data collection to support its safety."
Answered by AI
Who else is applying?
What site did they apply to?
Dana Farber Cancer Institute
What portion of applicants met pre-screening criteria?
Did not meet criteria
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