Giredestrant for Breast Cancer
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests giredestrant, a new treatment for early-stage breast cancer that is estrogen receptor positive (ER+) and not driven by the HER2 protein. The trial aims to assess patient adherence to the treatment and their experience when switching from an aromatase inhibitor (AI), which some cannot tolerate due to side effects. It targets postmenopausal women who have found AI therapy intolerable after at least six months of use. As a Phase 3 trial, it represents the final step before FDA approval, giving participants the opportunity to contribute to the potential availability of a new treatment option.
Do I have to stop taking my current medications for the trial?
The trial requires that you stop taking strong CYP3A inhibitors or inducers at least 14 days before starting the study treatment. It doesn't specify other medications, but you should discuss your current medications with the study team.
Is there any evidence suggesting that giredestrant is likely to be safe for humans?
Why do researchers think this study treatment might be promising for breast cancer?
Giredestrant is unique because it targets estrogen receptors in a novel way, potentially offering more effective management of hormone receptor-positive breast cancer. Unlike standard treatments like tamoxifen or aromatase inhibitors, which have been the mainstay for this condition, giredestrant is a selective estrogen receptor degrader (SERD). This means it not only blocks the receptor but also leads to its degradation, which could result in better efficacy and fewer side effects. Researchers are excited about this treatment because it promises a new approach that might overcome resistance seen with current therapies.
What evidence suggests that giredestrant might be an effective treatment for early breast cancer?
Research has shown that giredestrant, the investigational treatment in this trial, may effectively treat early breast cancer. In earlier studies, giredestrant reduced the risk of cancer recurrence or death by 30%. It also helped patients remain cancer-free longer compared to standard hormone treatments. Giredestrant blocks estrogen receptors, which can slow or halt cancer growth. Patients generally tolerated it well, with side effects similar to other hormone therapies. Overall, giredestrant could offer a new option for those who have faced challenges with previous treatments.23567
Who Is on the Research Team?
Clinical Trials
Principal Investigator
Genentech, Inc.
Are You a Good Fit for This Trial?
This trial is for postmenopausal women with early-stage (I-III) ER+/HER2- breast cancer who have tried aromatase inhibitor therapy for at least 6 months but had side effects that made it hard to continue. They must be switching from their first AI due to these intolerable symptoms.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive giredestrant as adjuvant endocrine therapy for ER+/HER2- early breast cancer
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Giredestrant
Trial Overview
The study looks at how well patients stick with and tolerate giredestrant, a new hormone therapy, after switching from an aromatase inhibitor because of side effects. It also collects patient feedback on their experience.
How Is the Trial Designed?
1
Treatment groups
Experimental Treatment
Find a Clinic Near You
Who Is Running the Clinical Trial?
Genentech, Inc.
Lead Sponsor
Ashley Magargee
Genentech, Inc.
Chief Executive Officer since 2024
MBA from Harvard University, BA from Princeton University
Levi Garraway
Genentech, Inc.
Chief Medical Officer since 2021
MD, PhD
Citations
Novel Endocrine Therapy, Giredestrant, Improves Invasive ...
The study met its primary endpoint of invasive disease–free survival, with a 30% reduction in the risk of invasive recurrence or death; this ...
Efficacy and safety of giredestrant (GIRE) in patients (pts) ...
Background: The lidERA BC trial (NCT04961996) demonstrated a statistically significant, clinically meaningful improvement in invasive disease-free survival ...
3.
cancertherapyadvisor.com
cancertherapyadvisor.com/reports/menopausal-status-giredestrant-efficacy-er-her2-early-breast-cancer/Menopausal Status Does Not Affect Giredestrant Efficacy in ...
Adjuvant giredestrant improves invasive DFS compared to ET, regardless of menopausal status, in women with ER+, HER2- early breast cancer.
4.
genentech-clinicaltrials.com
genentech-clinicaltrials.com/en/trials/cancer/bc/a-study-to-evaluate-efficacy-and-safety-of-giredestrant-50902.htmlClinical trial – giredestrant + CDKi in relapsed advanced...
A new ER blocker called giredestrant is given as a pill and may work better than fulvestrant, particularly against tumours with mutated ERs.
Giredestrant for Estrogen Receptor–Positive, HER2- ...
Giredestrant was well tolerated, with a safety profile comparable to PCET and consistent with known endocrine therapy risks. Overall, these data ...
6.
cancernetwork.com
cancernetwork.com/view/fda-grants-priority-review-giredestrant-er-her2-early-breast-cancerFDA Grants Priority Review to Giredestrant in ER+/HER2
giredestrant reduced the risk of invasive disease recurrence or death by 30% vs standard endocrine therapy. The 3-year invasive disease–free ...
7.
targetedonc.com
targetedonc.com/view/giredestrant-outperforms-standard-of-care-in-er-her2-early-breast-cancerGiredestrant Outperforms Standard of Care in ER+/HER2
Giredestrant's safety profile is consistent with previous data, with no new safety signals observed. outperforming standard of care.
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