300 Participants NeededMy employer runs this trial

Giredestrant for Breast Cancer

Recruiting at 1 trial location
RS
RS
Fr
Overseen ByFastest response: use the inquiry form. https://www.gene.com/contact-us/submit-medical-inquiry
Age: 18+
Sex: Female
Trial Phase: Phase 3
Sponsor: Genentech, Inc.
Must be taking: Aromatase inhibitors
Stay on Your Current MedsYou can continue your current medications while participating
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Pivotal Trial (Near Approval)This treatment is in the last trial phase before FDA approval
Prior Safety DataThis treatment has passed at least one previous human trial

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?

Research has shown that giredestrant is generally well tolerated by patients. Studies have found its safety profile similar to other hormone-blocking treatments. No new safety issues have emerged, suggesting that giredestrant is relatively safe, with expected and manageable side effects.12345

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?

CT

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

I am suitable for treatment with hormone therapy.
I have early-stage ER-positive, HER2-negative breast cancer.
My tumor has been tested and is HER2 negative.
See 7 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive giredestrant as adjuvant endocrine therapy for ER+/HER2- early breast cancer

12 months
Monthly visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

6 months

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

Group I: GiredestrantExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Genentech, Inc.

Lead Sponsor

Trials
1,578
Recruited
569,000+
Ashley Magargee profile image

Ashley Magargee

Genentech, Inc.

Chief Executive Officer since 2024

MBA from Harvard University, BA from Princeton University

Levi Garraway profile image

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 ...

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.

Clinical 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 ...

FDA 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 ...

Giredestrant 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.