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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
Must not have
Advanced, symptomatic, visceral spread that is at risk of life-threatening complications in the short term
Active cardiac disease or history of cardiac dysfunction, as defined in the protocol
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from baseline until treatment discontinuation (up to 78 months)
Awards & highlights
Pivotal Trial

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.
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.
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.

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 do not have any active heart problems or a history of heart issues.
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I have been treated with a SERD before.
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I haven't taken strong CYP3A affecting drugs recently.
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I do not have active brain metastases or related conditions that are uncontrolled.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from baseline until treatment discontinuation (up to 78 months)
This trial's timeline: 3 weeks for screening, Varies for treatment, and from baseline until treatment discontinuation (up to 78 months) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Secondary study objectives
Clinical Benefit Rate, as Determined by the Investigator According to RECIST v1.1
Number of Participants with Vital Sign Abnormalities Over the Course of the Study
Objective Response Rate, as Determined by the Investigator According to RECIST v1.1
+1 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

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 + 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
~3790
LHRH Agonist
2013
Completed Phase 2
~130
Giredestrant
2019
Completed Phase 2
~300

Find a Location

Who is running the clinical trial?

Hoffmann-La RocheLead Sponsor
2,456 Previous Clinical Trials
1,096,620 Total Patients Enrolled
158 Trials studying Breast Cancer
90,581 Patients Enrolled for Breast Cancer
Clinical TrialsStudy DirectorHoffmann-La Roche
2,225 Previous Clinical Trials
895,368 Total Patients Enrolled
137 Trials studying Breast Cancer
71,303 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
~75 spots leftby Mar 2025
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