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Hormone Therapy

Giredestrant vs. Fulvestrant for Advanced Breast Cancer

Phase 3

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

Documented estrogen receptor-positive (ER+), HER2-negative (HER2-) tumor assessed locally on the most recent tumor biopsy (or archived tumor sample)

Confirmed ESR1 mutation status (ESR1m vs. ESR1nmd) in baseline circulating tumor DNA (ctDNA) through central laboratory testing

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from randomization until end of follow-up (up to 5 years)

Awards & highlights

Study Summary

This trial will test if a new drug combo helps treat advanced breast cancer that has become resistant to endocrine therapy.

Who is the study for?

This trial is for adults with advanced breast cancer that's ER-positive, HER2-negative and has resisted previous endocrine therapy. They must have measurable disease or bone-only disease, be in good physical condition (ECOG PS 0-1), and pre/perimenopausal women and men need to use LHRH agonist therapy. People can't join if they've had certain prior treatments like SERDs, systemic therapies for advanced cancer, have serious heart or liver conditions, or are at immediate risk from their cancer.Check my eligibility

What is being tested?

The study compares the effectiveness of Giredestrant versus Fulvestrant when each is combined with a CDK4/6 inhibitor (chosen by the investigator) in participants who have developed resistance to adjuvant endocrine therapy. It's a Phase III trial where patients are randomly assigned to either treatment group.See study design

What are the potential side effects?

Possible side effects include hot flashes, nausea, injection site reactions from Fulvestrant; fatigue, diarrhea from CDK4/6 inhibitors; and potential unknown side effects from Giredestrant as it's newer.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My tumor is estrogen receptor-positive and HER2-negative.

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My cancer has a known ESR1 mutation status from a blood test.

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My cancer can be measured by scans or is only in my bones.

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I haven't had any drug treatments for my advanced cancer.

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I am taking hormone therapy as required if I am a pre/perimenopausal woman or a man.

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My breast cancer cannot be cured with surgery or radiation.

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I can carry out all my daily activities without help.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from randomization until end of follow-up (up to 5 years)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from randomization until end of follow-up (up to 5 years)

This trial's timeline: 3 weeks for screening, Varies for treatment, and from randomization until end of follow-up (up to 5 years) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

PFS in the Full Analysis Set (FAS) Population

Progression-Free Survival (PFS) in the ESR1 mutation (ESR1m) Subgroup

Secondary outcome measures

Clinical Benefit Rate (CBR)

Confirmed Objective Response Rate (cORR)

Duration of Response (DOR)

+11 more

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Giredestrant + Investigator's Choice of CDK4/6iExperimental Treatment6 Interventions

Participants in the experimental arm will receive giredestrant plus the investigator's choice of CDK4/6 inhibitor (CDK4/6i): palbociclib, ribociclib, or abemaciclib.

Group II: Fulvestrant + Investigator's Choice of CDK4/6iActive Control6 Interventions

Participants in the control arm will receive fulvestrant plus the investigator's choice of CDK4/6 inhibitor (CDK4/6i): palbociclib, ribociclib, or abemaciclib.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Ribociclib

2018

Completed Phase 3

~2330

Abemaciclib

2019

Completed Phase 2

~1710

Giredestrant

2019

Completed Phase 2

~300

Palbociclib

2017

Completed Phase 3

~3760

LHRH Agonist

2013

Completed Phase 2

~130

0 / 7Eligibility criteria met

Find a Location

Who is running the clinical trial?

Hoffmann-La RocheLead Sponsor

2,432 Previous Clinical Trials

1,089,111 Total Patients Enrolled

160 Trials studying Breast Cancer

91,442 Patients Enrolled for Breast Cancer

Clinical TrialsStudy DirectorHoffmann-La Roche

2,201 Previous Clinical Trials

887,828 Total Patients Enrolled

138 Trials studying Breast Cancer

72,096 Patients Enrolled for Breast Cancer

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there still opportunities available to join this clinical trial?

"Per the clinicaltrials.gov website, this scientific research endeavour is actively seeking participants. The trial was initially put up on November 24th 2023 and has been revised as recent as October 26th of that same year."

Answered by AI

Has the United States Food and Drug Administration endorsed Giredestrant in combination with a CDK4/6i inhibitor?

"Based on the data collected in Phase 3 trials, it is safe to assume Giredestrant + Investigator's Choice of CDK4/6i has a safety rating of 3. This indicates that there is ample evidence both supporting efficacy and multiple rounds of tests verifying its safety profile."

Answered by AI

How many participants is this experiment limited to?

"Affirmative. The clinical trial is recruiting participants, which began on November 24th 2023 and was most recently updated on October 26th 2023. This study needs to find 1050 patients from one centre."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

A Study to Evaluate Efficacy and Safety of Giredestrant Compared With Fulvestrant (Plus a CDK4/6 Inhibitor), in Participants With ER-Positive, HER2-Negative Advanced Breast Cancer Resistant to Adjuvant Endocrine Therapy (pionERA Breast Cancer)

2023. "A Study to Evaluate Efficacy and Safety of Giredestrant Compared With Fulvestrant (Plus a CDK4/6 Inhibitor), in Participants With ER-Positive, HER2-Negative Advanced Breast Cancer Resistant to Adjuvant Endocrine Therapy (pionERA Breast Cancer)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06065748.

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