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Giredestrant + Hormone Therapy for Early-Stage Breast Cancer
Phase 3
Recruiting
Research Sponsored by Hoffmann-La Roche
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Documented estrogen receptor (ER)-positive and HER2-negative breast tumor, as assessed locally on a primary disease specimen
Participants must have undergone definitive surgery of their primary breast tumor(s) and axillary lymph nodes (axillary lymph node dissection [ALND] and/or sentinel lymph node biopsy [SLNB])
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from randomization to death from any cause (up to 10 years)
Awards & highlights
Study Summary
This trial is testing whether adding the drug giredestrant to standard hormone therapy can improve outcomes for people with early-stage breast cancer.
Who is the study for?
This trial is for adults with early-stage, estrogen receptor-positive, HER2-negative breast cancer who've had surgery and possibly chemotherapy (with a 21-day gap before joining the study). They should be within 12 months post-surgery, have no prior endocrine therapy or other cancers in the last 3 years, and must not be pregnant. Good organ function and performance status are required.Check my eligibility
What is being tested?
The study compares Giredestrant, a new drug for breast cancer treatment after surgery (adjuvant), to standard endocrine therapies chosen by physicians. It's an open-label Phase III trial where participants are randomly assigned to either treatment group.See study design
What are the potential side effects?
Potential side effects of Giredestrant may include symptoms like nausea, fatigue, hot flashes, joint pain or changes in liver function tests. The exact side effects will vary depending on individual responses and the specific endocrine therapy used as a comparison.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My breast cancer is estrogen receptor positive and HER2 negative.
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I have had surgery to remove my breast tumor and lymph nodes.
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I am able to care for myself and perform daily activities.
Select...
My breast cancer is estrogen receptor positive and HER2 negative.
Select...
All my breast cancer tumors are ER positive and HER2 negative.
Select...
I have had surgery to remove my breast tumor and lymph nodes.
Select...
I finished my additional chemotherapy at least 21 days ago.
Select...
I have recovered from previous cancer treatments, except for hair loss or mild nerve pain.
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I had chemotherapy or surgery for breast cancer and no hormone therapy, enrolling within 12 months after my final surgery.
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I can provide a sample of my breast tumor for testing.
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My cancer affects lymph nodes but I meet other specific risk criteria.
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I can take care of myself and am up and about more than half of my waking hours.
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I can take pills without any issues.
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My organs are working well.
Select...
My breast cancer is estrogen receptor positive and HER2 negative.
Select...
I have had surgery to remove my breast tumor and lymph nodes.
Select...
I finished my additional chemotherapy at least 3 weeks ago.
Select...
I can take care of myself and am up and about more than half of my waking hours.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ from randomization to death from any cause (up to 10 years)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from randomization to death from any cause (up to 10 years)
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Invasive Disease-Free Survival (IDFS), Excluding Second Primary Non-Breast Cancers
Secondary outcome measures
Change from Baseline in the EQ 5D-5L Index-Based Score at Specified Timepoints
Change from Baseline in the EQ 5D-5L Visual Analogue Scale (VAS) Score at Specified Timepoints
Change from Baseline in the Mean Global Health Status/Quality of Life (QoL) Scale Score at Specified Timepoints, Assessed Using the EORTC QLQ-C30
+12 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%
Alopecia
5%
Rash
4%
Headache
3%
Constipation
2%
Procedural pain
1%
Myocardial infarction
1%
Pyrexia
1%
COVID-19
1%
Hip fracture
1%
Alanine aminotransferase increased
1%
Aspartate aminotransferase increased
1%
Uterine perforation
100%
80%
60%
40%
20%
0%
Study treatment Arm
Giredestrant + Palbociclib
Anastrozole + Palbociclib
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Arm A: GiredestrantExperimental Treatment2 Interventions
Group II: Arm B: Endocrine Therapy of Physician's ChoiceActive Control2 Interventions
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Giredestrant
2019
Completed Phase 2
~300
LHRH Agonist
2013
Completed Phase 2
~130
Find a Location
Who is running the clinical trial?
Hoffmann-La RocheLead Sponsor
2,427 Previous Clinical Trials
1,085,051 Total Patients Enrolled
160 Trials studying Breast Cancer
91,467 Patients Enrolled for Breast Cancer
Clinical TrialsStudy DirectorHoffmann-La Roche
2,198 Previous Clinical Trials
884,491 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:- My breast cancer is estrogen receptor positive and HER2 negative.I finished my additional chemotherapy at least 3 weeks ago.All my breast cancer tumors are ER positive and HER2 negative.I finished my additional chemotherapy at least 21 days ago.I had chemotherapy or surgery for breast cancer and no hormone therapy, enrolling within 12 months after my final surgery.I can take care of myself and am up and about more than half of my waking hours.I am taking or will take a CDK4/6 inhibitor for early-stage cancer treatment.I can take pills without any issues.I have severe liver disease, such as hepatitis or cirrhosis.I haven't taken strong CYP3A4 affecting drugs recently.I have a history of bleeding disorders or blood clots.I need dialysis for my kidney condition.I have not had major surgery unrelated to breast cancer in the last 28 days.I haven't had a serious infection or COVID-19 in the last 14 days.My breast cancer is estrogen receptor positive and HER2 negative.I have recovered from previous cancer treatments, except for hair loss or mild nerve pain.My cancer affects lymph nodes but I meet other specific risk criteria.I can provide a sample of my breast tumor for testing.My organs are working well.I am pre- or perimenopausal, or a male with a known allergy to LHRH agonists.I have had hormone therapy for cancer, but only a short course if it was before surgery.My breast cancer is estrogen receptor positive and HER2 negative.I have had surgery to remove my breast tumor and lymph nodes.I have recovered from previous cancer treatments, except for hair loss or mild nerve pain.All my breast cancer tumors are ER positive and HER2 negative.I finished my additional chemotherapy at least 3 weeks ago.I haven't had any cancer except for certain skin, cervical, or early uterine cancers in the last 3 years.I am not pregnant, breastfeeding, nor planning to become pregnant soon.I can take care of myself and am up and about more than half of my waking hours.I can take pills without any issues.My organs are working well.I have heart problems or have had them in the past.My breast cancer is at stage IV.I have had breast cancer or DCIS before, but only treated locally if it was on the opposite side.I don't have any serious health issues that would stop me from safely completing the study.I have had surgery to remove my breast tumor and lymph nodes.I had chemotherapy or surgery for breast cancer and haven't had hormone therapy, enrolling within 12 months after my surgery.I can provide a breast tumor tissue sample for testing.My cancer affects lymph nodes but I meet other specific risk criteria.I have had surgery to remove my breast tumor and lymph nodes.All my breast cancer tumors are ER positive and HER2 negative.I am able to care for myself and perform daily activities.I had chemotherapy or surgery for breast cancer and haven't had hormone therapy, enrolling within 12 months after my final surgery.
Research Study Groups:
This trial has the following groups:- Group 1: Arm A: Giredestrant
- Group 2: Arm B: Endocrine Therapy of Physician's Choice
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 are the effects of Giredestrant on patients?
"There is available data that suggests Giredestrant is effective and well tolerated, thus it was given a score of 3."
Answered by AI
Can you tell me if this research is still enrolling new subjects?
"Yes, this study is still looking for patients. According to the information available on clinicaltrials.gov, the trial was originally posted on 8/27/2021 and has been updated as recently as 11/3/2022. The study is looking for 4100 patients from 100 different locations."
Answered by AI
Who else is applying?
What state do they live in?
Alberta
Tennessee
Louisiana
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
What site did they apply to?
Hematology/Oncology Clinic, LLP
Messino Cancer Centers
Aultman Hospital
Other
How many prior treatments have patients received?
0
Why did patients apply to this trial?
I want some different of quimioterapy. I m looking for more personalize and other tricmen diferent.
PatientReceived 1 prior treatment
Hoping that this research would help others feel better in the future.
PatientReceived 2+ prior treatments
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