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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 belowSelect...
I am fully active or can carry out light work.
Select...
I am receiving hormone therapy to manage my cancer.
Select...
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.
Select...
My tumor is ER-positive and HER2-negative.
Select...
My breast cancer has spread and cannot be cured with surgery or radiation.
Select...
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:Select...
My cancer has spread to vital organs and poses an immediate risk to my life.
Select...
I do not have any active heart problems or a history of heart issues.
Select...
I have been treated with a SERD before.
Select...
I haven't taken strong CYP3A affecting drugs recently.
Select...
I do not have active brain metastases or related conditions that are uncontrolled.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ from baseline until treatment discontinuation (up to 78 months)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from baseline until treatment discontinuation (up to 78 months)
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 moreSide effects data
From 2021 Phase 2 trial • 221 Patients • NCT0443674441%
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
2,459 Previous Clinical Trials
1,096,052 Total Patients Enrolled
158 Trials studying Breast Cancer
90,581 Patients Enrolled for Breast Cancer
Clinical TrialsStudy DirectorHoffmann-La Roche
2,228 Previous Clinical Trials
894,998 Total Patients Enrolled
137 Trials studying Breast Cancer
71,303 Patients Enrolled for Breast Cancer
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am fully active or can carry out light work.I am receiving hormone therapy to manage my cancer.I have cancer that can be measured by scans or have a specific type of bone lesion.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.My tumor is ER-positive and HER2-negative.My organs are working well.My cancer has spread to vital organs and poses an immediate risk to my life.My breast cancer has spread and cannot be cured with surgery or radiation.My cancer came back within a year after treatment with a CDK4/6 inhibitor.I do not have any active heart problems or a history of heart issues.I haven't had systemic anti-cancer therapy for advanced or metastatic disease.I have been treated with a SERD before.I haven't taken strong CYP3A affecting drugs recently.Both of my breast cancers are ER-positive and HER2-negative, making me eligible for the study.I do not have active brain metastases or related conditions that are uncontrolled.
Research Study Groups:
This trial has the following groups:- Group 1: Giredestrant + Letrozole-matched Placebo + Palbociclib
- Group 2: Letrozole + Giredestrant-matched Placebo + Palbociclib
Awards:
This trial has 1 awards, including:- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.