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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 from randomization to death from any cause (up to 10 years)
Awards & highlights

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 below
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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.
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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 finished my additional chemotherapy at least 21 days ago.
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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 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 finished my additional chemotherapy at least 3 weeks ago.
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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:
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I have heart problems or have had them in the past.
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My breast cancer is at stage IV.
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I have severe liver disease, such as hepatitis or cirrhosis.
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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 weeks
Treatment ~ Varies
Follow Up ~from randomization to death from any cause (up to 10 years)
This trial's timeline: 3 weeks for screening, Varies for treatment, and from randomization to death from any cause (up to 10 years) for reporting.

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 more

Side effects data

From 2021 Phase 2 trial • 221 Patients • NCT04436744
41%
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

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

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.

Find a Location

Who is running the clinical trial?

Hoffmann-La RocheLead Sponsor
2,436 Previous Clinical Trials
1,087,535 Total Patients Enrolled
160 Trials studying Breast Cancer
90,892 Patients Enrolled for Breast Cancer
Clinical TrialsStudy DirectorHoffmann-La Roche
2,204 Previous Clinical Trials
886,206 Total Patients Enrolled
138 Trials studying Breast Cancer
71,546 Patients Enrolled for Breast Cancer

Media Library

Endocrine Therapy of Physician's Choice Clinical Trial Eligibility Overview. Trial Name: NCT04961996 — Phase 3
Breast Cancer Research Study Groups: Arm A: Giredestrant, Arm B: Endocrine Therapy of Physician's Choice
Breast Cancer Clinical Trial 2023: Endocrine Therapy of Physician's Choice Highlights & Side Effects. Trial Name: NCT04961996 — Phase 3
Endocrine Therapy of Physician's Choice 2023 Treatment Timeline for Medical Study. Trial Name: NCT04961996 — Phase 3
~1286 spots leftby Dec 2025