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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])
Must not have
Active cardiac disease or history of cardiac dysfunction
Diagnosed with Stage IV breast cancer
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
No Placebo-Only Group
Pivotal Trial
Summary
This trial is testing giredestrant, a medication given after initial treatment to prevent breast cancer from returning. It focuses on patients with a specific type of early-stage breast cancer that is hormone-driven and at higher risk of recurrence. Giredestrant works by blocking the hormone estrogen from helping cancer cells grow. Giredestrant has shown promise in previous studies.
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.
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.
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.
Select...
I have had surgery to remove my breast tumor and lymph nodes.
Select...
I am able to care for myself and perform daily activities.
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 21 days ago.
Select...
I can take care of myself and am up and about more than half of my waking hours.
Select...
I can take pills without any issues.
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.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have heart problems or have had them in the past.
Select...
My breast cancer is at stage IV.
Select...
I have severe liver disease, such as hepatitis or cirrhosis.
Select...
I haven't taken strong CYP3A4 affecting drugs recently.
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I am pre- or perimenopausal, or a male with a known allergy to LHRH agonists.
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I have a history of bleeding disorders or blood clots.
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I need dialysis for my kidney condition.
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I have not had major surgery unrelated to breast cancer in the last 28 days.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
Treatment Details
Side 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
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.
Trial Design
3Treatment groups
Experimental Treatment
Active Control
Group I: Substudy: Giredestrant + Abemaciclib, Then GiredestrantExperimental Treatment2 Interventions
In this substudy, participants will receive giredestrant in combination with abemaciclib for up to 2 years. Participants will continue with giredestrant monotherapy for an additional 3 years in order to complete a total of 5 years on study treatment.
Group II: Arm A: GiredestrantExperimental Treatment2 Interventions
Group III: Arm B: Endocrine Therapy of Physician's ChoiceActive Control2 Interventions
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Abemaciclib
2019
Completed Phase 2
~1890
Giredestrant
2019
Completed Phase 2
~300
LHRH Agonist
2013
Completed Phase 2
~130
Research Highlights
Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Selective Estrogen Receptor Degraders (SERDs) like Giredestrant work by binding to estrogen receptors on breast cancer cells, leading to receptor degradation and downregulation, which inhibits the cancer cells' growth. This is crucial for patients with estrogen receptor-positive breast cancer, as it directly targets the hormone-driven growth mechanism.
In comparison, Selective Estrogen Receptor Modulators (SERMs) such as tamoxifen block estrogen receptors, and aromatase inhibitors like anastrozole reduce estrogen production. Understanding these mechanisms helps patients and doctors choose the most effective treatment based on the cancer's specific characteristics and resistance patterns.
Premenopausal women with early breast cancer treated with estradiol suppression have severely deteriorated bone microstructure.Molecular mechanisms of endocrine resistance and their implication in the therapy of breast cancer.
Premenopausal women with early breast cancer treated with estradiol suppression have severely deteriorated bone microstructure.Molecular mechanisms of endocrine resistance and their implication in the therapy of breast cancer.
Find a Location
Who is running the clinical trial?
Hoffmann-La RocheLead Sponsor
2,463 Previous Clinical Trials
1,098,927 Total Patients Enrolled
Clinical TrialsStudy DirectorHoffmann-La Roche
2,233 Previous Clinical Trials
898,037 Total Patients Enrolled
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: Substudy: Giredestrant + Abemaciclib, Then Giredestrant
- Group 2: Arm A: Giredestrant
- Group 3: 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.