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Hormone Therapy

Giredestrant + Palbociclib vs Letrozole + Palbociclib for Breast Cancer

Phase 3

Waitlist Available

Research Sponsored by Hoffmann-La Roche

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Eastern Cooperative Oncology Group Performance Status 0-1

For women who are premenopausal or perimenopausal and for men: treatment with approved LHRH agonist therapy for the duration of study treatment

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from randomization to death from any cause (up to 78 months)

Awards & highlights

Study Summary

This trial will compare two treatments for breast cancer: giredestrant with palbociclib, and letrozole with palbociclib. The trial will measure how well the treatments work and how safe they are.

Who is the study for?

This trial is for adults with ER-positive, HER2-negative advanced or metastatic breast cancer who haven't had systemic anti-cancer therapy for their advanced disease. They should have completed at least 24 months of standard adjuvant endocrine therapy without progression and be over a year since the last treatment. Pre/peri-menopausal women and men must use LHRH agonist therapy.Check my eligibility

What is being tested?

The study compares the effectiveness and safety of two treatments: Giredestrant combined with Palbociclib versus Letrozole combined with Palbociclib. It's a Phase III trial where participants are randomly assigned to either treatment in a double-blind manner, meaning neither they nor the researchers know which group they're in.See study design

What are the potential side effects?

Potential side effects include reactions related to hormone therapies such as hot flashes, joint pain, and fatigue; from Palbociclib like low white blood cell counts increasing infection risk; plus general drug-related issues like nausea, hair thinning, or diarrhea.

Eligibility Criteria

Inclusion Criteria

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

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I am fully active or can carry out light work.

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I am receiving hormone therapy to manage my cancer.

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My early-stage breast cancer returned after I completed at least 2 years of hormone therapy without the cancer getting worse, and I was disease-free for more than a year after finishing treatment.

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My tumor is ER-positive and HER2-negative.

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My breast cancer has spread and cannot be cured with surgery or radiation.

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I haven't had systemic anti-cancer therapy for advanced or metastatic disease.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from randomization to death from any cause (up to 78 months)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from randomization to death from any cause (up to 78 months)

This trial's timeline: 3 weeks for screening, Varies for treatment, and from randomization to death from any cause (up to 78 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 (PFS), as Determined by the Investigator According to RECIST v1.1

Secondary outcome measures

Clinical Benefit Rate, as Determined by the Investigator According to RECIST v1.1

Duration of Response, as Determined by the Investigator According to RECIST v1.1

Number of Participants with Adverse Events, Severity Determined According to National Cancer Institute Common Terminology Criteria for Adverse Events, Version 5.0 (NCI-CTCAE v5.0)

+10 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 + Letrozole-matched Placebo + PalbociclibExperimental Treatment4 Interventions

Group II: Letrozole + Giredestrant-matched Placebo + PalbociclibActive Control4 Interventions

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Palbociclib

2017

Completed Phase 3

~3760

LHRH Agonist

2013

Completed Phase 2

~130

Giredestrant

2019

Completed Phase 2

~300

0 / 6Eligibility criteria met

Find a Location

Who is running the clinical trial?

Hoffmann-La RocheLead Sponsor

2,428 Previous Clinical Trials

1,088,062 Total Patients Enrolled

160 Trials studying Breast Cancer

91,467 Patients Enrolled for Breast Cancer

Clinical TrialsStudy DirectorHoffmann-La Roche

2,199 Previous Clinical Trials

887,510 Total Patients Enrolled

138 Trials studying Breast Cancer

72,096 Patients Enrolled for Breast Cancer

Media Library

Giredestrant (Hormone Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT04546009 — Phase 3

Breast Cancer Research Study Groups: Giredestrant + Letrozole-matched Placebo + Palbociclib, Letrozole + Giredestrant-matched Placebo + Palbociclib

Breast Cancer Clinical Trial 2023: Giredestrant Highlights & Side Effects. Trial Name: NCT04546009 — Phase 3

Giredestrant (Hormone Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04546009 — Phase 3

Frequently Asked Questions

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

At how many sites can patients enroll in this trial?

"Presently, this research is recruiting individuals from a total of 76 sites. While the primary sites are in Montvale, Houston and Harrison, other locations include... It is crucial to choose a site near you to cut down on travel if you do decide to take part in this study."

Answered by AI

Does Giredestrant have the official go-ahead from the FDA?

"Giredestrant is considered safe, as it has received a score of 3. This is due to the fact that it is a Phase 3 trial, meaning that there is both evidence of its efficacy and safety from multiple rounds of testing."

Answered by AI

What is the main condition that Giredestrant is used to target?

"Giredestrant is an effective medication for patients suffering from endocrine therapy-resistant breast cancer, advanced HR+ HER2- breast cancer, and malignant neoplasms."

Answered by AI

Can people with the relevant medical condition still sign up for this research project?

"The latest information from clinicaltrials.gov shows that this study is actively looking for participants. The trial was first announced on October 9th, 2020 and was last updated on October 28th, 2020."

Answered by AI

What are other similar studies to the one involving Giredestrant?

"First studied in 1995 at the National Institutes of Health Clinical Center, giredestrant has become the subject of 253 completed trials. Currently, there are 264 active studies, many of which are based in Montvale, New jersey."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

A Study Evaluating the Efficacy and Safety of Giredestrant Combined With Palbociclib Compared With Letrozole Combined With Palbociclib in Participants With Estrogen Receptor-Positive, HER2-Negative Locally Advanced or Metastatic Breast Cancer (persevERA Breast Cancer)

2020. "A Study Evaluating the Efficacy and Safety of Giredestrant Combined With Palbociclib Compared With Letrozole Combined With Palbociclib in Participants With Estrogen Receptor-Positive, HER2-Negative Locally Advanced or Metastatic Breast Cancer (persevERA Breast Cancer)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04546009.

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