Your session is about to expire
← Back to Search
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from randomization to death from any cause (up to approximately 36 months)
Awards & highlights
Study Summary
This trial will compare the effects of giredestrant vs. other hormone therapies in patients with breast cancer that has spread and who have already tried other treatments.
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.Check my eligibility
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.See study design
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 belowSelect...
My breast cancer cannot be cured with surgery or radiation.
Select...
I am willing to undergo hormone therapy if I am a premenopausal or perimenopausal woman, or a man.
Select...
My tumor is ER-positive and HER2-negative.
Select...
My cancer has worsened after 1 or 2 treatments, but I've only had one targeted therapy.
Select...
I am a woman who has gone through menopause or am approaching it.
Select...
I am fully active or can carry out light work.
Select...
I have cancer that can be measured by scans or have a specific type of bone lesion.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ from randomization to death from any cause (up to approximately 36 months)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from randomization to death from any cause (up to approximately 36 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 (PFS), as Determined by the Investigator According to Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST v1.1)
Secondary outcome measures
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
+12 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
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
Find a Location
Who is running the clinical trial?
Hoffmann-La RocheLead Sponsor
2,430 Previous Clinical Trials
1,089,107 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
888,429 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 cannot be cured with surgery or radiation.I am willing to undergo hormone therapy if I am a premenopausal or perimenopausal woman, or a man.My tumor is ER-positive and HER2-negative.I have not been treated with SERDs, except for fulvestrant which I stopped at least 28 days ago.My cancer has worsened after 1 or 2 treatments, but I've only had one targeted therapy.I am a woman who has gone through menopause or am approaching it.My cancer has spread to vital organs and could cause serious health issues.My organs are working well.I have heart problems or have had them in the past.I do not have active brain metastases or related conditions.I am fully active or can carry out light work.I have cancer that can be measured by scans or have a specific type of bone lesion.
Research Study Groups:
This trial has the following groups:- Group 1: Physician Choice of Endocrine Monotherapy
- Group 2: Giredestrant
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
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.
Does Giredestrant pose any significant hazards to human health?
"In light of the fact that Giredestrant is in its Phase 2 trial, our team at Power has assigned it a score of two for safety; thus far we've seen data to suggest security but no evidence on efficacy."
Answered by AI
In what ailments does Giredestrant usually provide relief?
"Giredestrant is traditionally prescribed for patients who have already tried endocrine therapy. Additionally, it can be beneficial to those with diseases like breast cancer and individuals whose bodies possess the pik3ca gene mutation."
Answered by AI
What is the current size of the cohort involved in this investigation?
"As of now, this particular trial is not in search for participants. It was initially listed on November 27th 2020 and last modified on November 7th 2022. If you are looking at other studies, there are 2232 clinical trials recruiting individuals with malignant neoplasm of breast and 133 research initiatives hoping to enroll patients into Giredestrant therapy."
Answered by AI
Are there any other studies that have focused on the effects of Giredestrant?
"Back in 2004, Lowell General Hospital was the first to begin researching giredestrant. Over 92 completed trials have been conducted thus far and 133 studies are still ongoing across various cities, with many of them located in Austin, Texas."
Answered by AI
How many locations are currently investigating the effects of this trial?
"The trial is recruiting at Texas Oncology Cancer Center in Austin, Northwest Cancer Specialists - Portland (SW Barnes Rd) in Tigard and St. Vincent Frontier Cancer center in Billings along with 10 additional sites."
Answered by AI
Are there any vacancies left for participants in this research trial?
"As currently listed on clinicaltrials.gov, this medical study is not actively seeking candidates as it was last updated in November of 2022. Nonetheless, there are a plethora of other trials that are presently recruiting participants for their studies."
Answered by AI
Other Trials to Consider
Popular Categories
Share this study with friends
Copy Link
Messenger