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Aromatase Inhibitor

Giredestrant for Advanced Breast Cancer

Phase 2
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
Locally advanced or metastatic adenocarcinoma of the breast, not amenable to treatment with curative intent
For women who are premenopausal or perimenopausal and for men: willing to undergo and maintain 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
Active cardiac disease or history of cardiac dysfunction
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from randomization to death from any cause (up to approximately 36 months)
Awards & highlights
No Placebo-Only Group

Summary

This trial is testing giredestrant, a new drug, to see if it works better than usual hormone treatments for certain breast cancer patients. It targets patients whose cancer grows with the help of estrogen and who have already tried other treatments. The drug aims to block a protein that helps the cancer grow.

Who is the study for?
This trial is for postmenopausal or premenopausal women with ER-positive, HER2-negative advanced breast cancer who've had 1-2 systemic therapies but not more than one targeted therapy. They must have good organ function and agree to LHRH agonist therapy if premenopausal. Exclusions include active heart disease, uncontrolled brain metastases, life-threatening visceral spread, prior SERD treatment (except fulvestrant), investigational drug use within 28 days, or being pregnant/breastfeeding.
What is being tested?
The study compares the effectiveness of Giredestrant against a physician's choice of endocrine monotherapy in patients with certain types of advanced breast cancer. It's an open-label Phase II trial where participants are randomly assigned to receive either Giredestrant or another hormone therapy chosen by their doctor.
What are the potential side effects?
Potential side effects may include hot flashes, joint pain, fatigue, nausea and vomiting related to hormonal treatments like Fulvestrant or Aromatase Inhibitors. Side effects specific to Giredestrant aren't detailed but could be similar due to its nature as a selective estrogen receptor degrader.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My breast cancer cannot be cured with surgery or radiation.
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I am willing to undergo hormone therapy if I am a premenopausal or perimenopausal woman, or a man.
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My tumor is ER-positive and HER2-negative.
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My cancer has worsened after 1 or 2 treatments, but I've only had one targeted therapy.
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I am a woman who has gone through menopause or am approaching it.
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I am fully active or can carry out light work.
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I have cancer that can be measured by scans or have a specific type of bone lesion.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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My cancer has spread to vital organs and could cause serious health issues.
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I have heart problems or have had them in the past.
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I do not have active brain metastases or related conditions.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from randomization to death from any cause (up to approximately 36 months)
This trial's timeline: 3 weeks for screening, Varies for treatment, and from randomization to death from any cause (up to approximately 36 months) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Progression-Free Survival (PFS), as Determined by the Investigator According to Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST v1.1)
Secondary study objectives
Clinical Benefit Rate, as Determined by the Investigator According to RECIST v1.1
Duration of Response (DOR), as Determined by the Investigator According to RECIST v1.1
Investigator-Assessed PFS, in Subgroups Categorized by Estrogen Receptor 1 (ESR1) Mutation Status
+11 more

Side effects data

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

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: GiredestrantExperimental Treatment2 Interventions
Group II: Physician Choice of Endocrine MonotherapyActive Control2 Interventions
The physician choice of endocrine monotherapy will be limited to fulvestrant or an aromatase inhibitor.
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
Breast cancer treatments often target specific mechanisms to inhibit cancer growth. Endocrine therapies, such as Selective Estrogen Receptor Degraders (SERDs) like giredestrant, work by binding to estrogen receptors on cancer cells, leading to receptor degradation and blocking estrogen-driven tumor growth. This is crucial for patients with estrogen receptor-positive (ER-positive) breast cancer, as it directly targets the hormone dependency of their tumors. Other common treatments include chemotherapy, which kills rapidly dividing cells, and HER2-targeted therapies, which inhibit the HER2 protein that promotes cancer cell growth. Understanding these mechanisms helps tailor treatments to the cancer's specific characteristics, improving efficacy and patient outcomes.

Find a Location

Who is running the clinical trial?

Hoffmann-La RocheLead Sponsor
2,450 Previous Clinical Trials
1,095,181 Total Patients Enrolled
159 Trials studying Breast Cancer
90,650 Patients Enrolled for Breast Cancer
Clinical TrialsStudy DirectorHoffmann-La Roche
2,220 Previous Clinical Trials
895,088 Total Patients Enrolled
137 Trials studying Breast Cancer
71,304 Patients Enrolled for Breast Cancer

Media Library

Aromatase Inhibitor (Physician's Choice) (Aromatase Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT04576455 — Phase 2
Breast Cancer Research Study Groups: Physician Choice of Endocrine Monotherapy, Giredestrant
Breast Cancer Clinical Trial 2023: Aromatase Inhibitor (Physician's Choice) Highlights & Side Effects. Trial Name: NCT04576455 — Phase 2
Aromatase Inhibitor (Physician's Choice) (Aromatase Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04576455 — Phase 2
~62 spots leftby Oct 2025