Your session is about to expire
← Back to Search
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Complete a minimum of four cycles of induction therapy
Achieve a minimum of stable disease (SD) (or Non-complete response [CR]/Non-progressive disease [PD] for participants with non-measurable disease) (i.e., did not experience PD) according to RECIST v1.1 at the last tumor assessment during the induction therapy phase
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from randomization for maintenance therapy to death from any cause (up to 122 months)
Awards & highlights
Study Summary
This trial will compare the effectiveness of two treatments for HER2-positive, ER-positive breast cancer that has spread or can't be removed with surgery. One treatment is giredestrant plus Phesgo, and the other is Phesgo alone. The trial will also look at the safety of the two treatments.
Who is the study for?
This trial is for adults with HER2-positive, ER-positive advanced breast cancer that can't be removed by surgery. They should have completed at least four cycles of induction therapy without disease progression and have a heart function (LVEF) ≥50%. Participants must not have had certain previous cancer treatments, uncontrolled health issues, or been pregnant or breastfeeding.Check my eligibility
What is being tested?
The study compares the effectiveness and safety of Giredestrant combined with Phesgo versus Phesgo alone in patients after initial treatment with Phesgo plus taxane. It's a Phase III trial where participants are randomly assigned to one of two groups to see which treatment works better.See study design
What are the potential side effects?
Possible side effects include reactions related to hormone therapies, infusion-related reactions from antibody drugs like those in Phesgo, and typical chemotherapy side effects such as fatigue, nausea, hair loss, low blood cell counts increasing infection risk.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have completed at least four cycles of initial cancer treatment.
Select...
My cancer did not worsen after the initial treatment phase.
Select...
My breast cancer is HER2 and ER positive and cannot be surgically removed.
Select...
I am fully active or can carry out light work.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ from randomization for maintenance therapy to death from any cause (up to 122 months)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from randomization for maintenance therapy to death from any cause (up to 122 months)
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, 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
Mean Change from Baseline in the Global Health Status/Quality of Life Score Over Time, as Assessed Using the European Organisation for Research and Treatment of Cancer Quality of Life-Core 30 (EORTC QLQ-C30) Questionnaire
+9 moreSide effects data
From 2021 Phase 2 trial • 221 Patients • NCT0443674441%
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
3Treatment groups
Experimental Treatment
Active Control
Group I: Induction Therapy: Phesgo plus Taxane-Based ChemotherapyExperimental Treatment3 Interventions
Group II: Arm B, Maintenance Therapy: Giredestrant plus PhesgoExperimental Treatment3 Interventions
Group III: Arm A, Maintenance Therapy: PhesgoActive Control3 Interventions
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Paclitaxel
2011
Completed Phase 4
~5380
Giredestrant
2019
Completed Phase 2
~300
Docetaxel
1995
Completed Phase 4
~5620
LHRH Agonist
2013
Completed Phase 2
~130
Find a Location
Who is running the clinical trial?
Hoffmann-La RocheLead Sponsor
2,432 Previous Clinical Trials
1,089,411 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
888,128 Total Patients Enrolled
138 Trials studying Breast Cancer
72,096 Patients Enrolled for Breast Cancer
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I haven't taken strong CYP3A4 inhibitors or inducers in the last 14 days or longer.I have been treated with a SERD medication before.All side effects from my previous cancer treatments have mostly gone away.I have completed at least four cycles of initial cancer treatment.My cancer did not worsen after the initial treatment phase.I haven't had major surgery or a serious injury in the last 14 days and don't expect to need major surgery soon.My high blood pressure is not well-managed.I have not exceeded the maximum safe doses of specific chemotherapy drugs.I have had one non-hormonal cancer treatment for advanced or metastatic breast cancer.I do not have any serious health issues that would make it unsafe for me to join the study.I have at least one tumor that can be measured or evaluated.I am allergic to or unwilling to take hormone therapy that affects my reproductive hormones.My cancer returned 6 months or more after finishing my initial treatment.Your heart's pumping ability is normal, as determined by a recent assessment.I have a serious liver condition or disease.I am not pregnant or breastfeeding and do not plan to become pregnant during the study or within 7 months after the last dose.I have been treated with specific anti-HER2 drugs for breast cancer, but not in the advanced setting.I haven't had any experimental treatments in the last 28 days.My breast cancer is HER2 and ER positive and cannot be surgically removed.I haven't had any cancer except for the one being studied or low-risk cancers in the last 5 years.I do not have active brain metastases or related conditions.My cancer worsened within 6 months after finishing treatment targeting HER2.I agree to not have unprotected sex or donate sperm for 7 months after my last dose.I have been on daily steroids for more than 3 months.I am HIV positive but stable on treatment, with good immune function and no recent serious infections.I am fully active or can carry out light work.I received targeted pain relief radiation within the last 2 weeks.I have an active inflammatory bowel condition or have had major gut surgery.I haven't had a serious COVID-19 infection in the last 14 days.I have heart problems or have had them in the past.I haven't taken antibiotics for a serious infection in the last 7 days.My blood and organs are functioning well.I have a history of bleeding disorders or blood clots but they are now under control.Your heart's pumping function is at least 50%, as measured by a heart ultrasound or a special heart scan.I have long-lasting moderate to severe blood-related side effects from previous cancer treatments.I need oxygen all the time due to my advanced cancer.
Research Study Groups:
This trial has the following groups:- Group 1: Arm A, Maintenance Therapy: Phesgo
- Group 2: Arm B, Maintenance Therapy: Giredestrant plus Phesgo
- Group 3: Induction Therapy: Phesgo plus Taxane-Based Chemotherapy
Awards:
This trial has 2 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- 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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What is the most recent status of Giredestrant's FDA approval?
"Giredestrant's safety has been well documented in both Phase 3 clinical trials and other research, so it received a score of 3."
Answered by AI
Are people with the relevant medical condition still able to sign up for this trial?
"The most up-to-date information on clinicaltrials.gov shows that this study is still looking for participants. This trial was first advertised on July 4th, 2022 and the page was last updated on October 28th, 2022."
Answered by AI
How many individuals have signed up for this research project?
"A total of 812 individuals are needed for this study, provided they meet the necessary inclusion criteria. These patients can come from multiple locations, such as Florida Cancer Specialists - EAST - SCRI - PPDS in West Palm Beach, Florida and Genesis Cancer Center in Hot Springs, Arkansas."
Answered by AI
Who else is applying?
What state do they live in?
Tennessee
What site did they apply to?
West Cancer Center
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
2
Other Trials to Consider
Popular Categories
Share this study with friends
Copy Link
Messenger