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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 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
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 + 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
LHRH Agonist
2013
Completed Phase 2
~130
Palbociclib
2017
Completed Phase 3
~3760
Giredestrant
2019
Completed Phase 2
~300

Find a Location

Who is running the clinical trial?

Hoffmann-La RocheLead Sponsor
2,434 Previous Clinical Trials
1,090,400 Total Patients Enrolled
160 Trials studying Breast Cancer
91,442 Patients Enrolled for Breast Cancer
Clinical TrialsStudy DirectorHoffmann-La Roche
2,202 Previous Clinical Trials
889,044 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
~168 spots leftby Mar 2025
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