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mTOR Inhibitor

Giredestrant + Everolimus for Advanced or Metastatic Breast Cancer

Phase 3
Waitlist Available
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
Must not have
Advanced, symptomatic, visceral spread that is at risk of life-threatening complications in the short term
Interstitial lung disease or severe dyspnea at rest or requiring oxygen therapy
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from baseline until progressive disease or death (up to 42 months)
Awards & highlights
No Placebo-Only Group
Pivotal Trial

Summary

This trial is testing if a combination of giredestrant and everolimus works better than other hormone treatments plus everolimus in patients with advanced breast cancer who have already tried other treatments. The drugs work by blocking estrogen receptors and a growth pathway in cancer cells. Everolimus has been shown to improve outcomes in breast cancer patients when combined with hormonal treatments.

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.
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.
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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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My cancer has spread to vital organs and poses an immediate risk to my life.
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I have a lung condition that makes it hard to breathe without help.
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I am sensitive to certain hormone therapies due to my premenopausal or perimenopausal status, or as a man.
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I haven't had major surgery or cancer treatment in the last 14 days.
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I do not have active brain metastases or related conditions.
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I have a serious liver condition, such as hepatitis, alcohol abuse, or cirrhosis.
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My breast cancer has worsened after two or more hormone treatments.
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I have had chemotherapy for cancer that could not be surgically removed or has spread.
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I have heart problems or have had them in the past.
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I have an active inflammatory bowel condition or have had major GI surgery.
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I haven't had a serious infection needing antibiotics in the last 2 weeks.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from baseline until progressive disease or death (up to 42 months)
This trial's timeline: 3 weeks for screening, Varies for treatment, and from baseline until progressive disease or death (up to 42 months) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Progression-Free Survival, as Determined by the Investigator According to RECIST v1.1, in the ESR1m Subpopulation and ITT Population
Secondary study objectives
Clinical Benefit Rate (CBR), as Determined by the Investigator According to RECIST v1.1, in the ESR1m Subpopulation and ITT Population
Number of Participants with Vital Sign Abnormalities Over the Course of the Study
Objective Response Rate (ORR), as Determined by the Investigator According to RECIST v1.1, in the ESR1m Subpopulation and ITT Population
+5 more

Side effects data

From 2021 Phase 2 trial • 221 Patients • NCT04436744
41%
Neutropenia
23%
Neutrophil count decreased
22%
Asthenia
14%
Nausea
14%
Hot flush
13%
Leukopenia
13%
White blood cell count decreased
11%
Anaemia
11%
Arthralgia
9%
Fatigue
8%
Mucosal inflammation
7%
Diarrhoea
5%
Vomiting
5%
Rash
5%
Alopecia
4%
Headache
3%
Constipation
2%
Procedural pain
1%
Hip fracture
1%
COVID-19
1%
Pyrexia
1%
Myocardial infarction
1%
Uterine perforation
1%
Aspartate aminotransferase increased
1%
Alanine aminotransferase increased
100%
80%
60%
40%
20%
0%
Study treatment Arm
Giredestrant + Palbociclib
Anastrozole + Palbociclib

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

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
1,563 Previous Clinical Trials
569,769 Total Patients Enrolled
Clinical TrialsStudy DirectorGenentech, Inc.
2,227 Previous Clinical Trials
896,102 Total Patients Enrolled

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
~112 spots leftby Mar 2026
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