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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 below
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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 weeks
Treatment ~ Varies
Follow Up ~from randomization until death from any cause (up to 42 months)
This trial's timeline: 3 weeks for screening, Varies for treatment, and from randomization until death from any cause (up to 42 months) for reporting.

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 more

Side effects data

From 2021 Phase 2 trial • 221 Patients • NCT04436744
41%
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
LHRH Agonist
2013
Completed Phase 2
~130
Everolimus
2010
Completed Phase 4
~1510
Giredestrant
2019
Completed Phase 2
~300

Find a Location

Who is running the clinical trial?

Genentech, Inc.Lead Sponsor
1,542 Previous Clinical Trials
567,792 Total Patients Enrolled
97 Trials studying Breast Cancer
23,218 Patients Enrolled for Breast Cancer
Clinical TrialsStudy DirectorGenentech, Inc.
2,204 Previous Clinical Trials
889,986 Total Patients Enrolled
138 Trials studying Breast Cancer
71,546 Patients Enrolled for Breast Cancer

Media Library

Everolimus (mTOR Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT05306340 — Phase 3
Breast Cancer Research Study Groups: Physician's Choice of Endocrine Therapy plus Everolimus, Giredestrant plus Everolimus
Breast Cancer Clinical Trial 2023: Everolimus Highlights & Side Effects. Trial Name: NCT05306340 — Phase 3
Everolimus (mTOR Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05306340 — Phase 3
~37 spots leftby Oct 2024