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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

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 randomization until death from any cause (up to 42 months)

Awards & highlights

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.

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 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)

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

Fatigue

Mucosal inflammation

Diarrhoea

Alopecia

Rash

Vomiting

Headache

Constipation

Procedural pain

Aspartate aminotransferase increased

Uterine perforation

Pyrexia

COVID-19

Myocardial infarction

Alanine aminotransferase increased

Hip fracture

100%

80%

60%

40%

20%

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

0 / 16Eligibility criteria met

Find a Location

Who is running the clinical trial?

Genentech, Inc.Lead Sponsor

1,542 Previous Clinical Trials

567,757 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

~25 spots leftby Oct 2024

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