Giredestrant for Endometrial Cancer

(EndomERA Trial)

Recruiting at 18 trial locations

Overseen By Reference Study ID Number: CO44195 https://forpatients.roche.com/

Age: 18+

Sex: Female

Trial Phase: Phase 2

Sponsor: Hoffmann-La Roche

Must not be taking: CYP3A4 inhibitors, CYP3A4 inducers

Disqualifiers: Pregnancy, Non-endometrioid histologies, Metastatic disease, Severe infection, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 6 months

30 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests the effectiveness and safety of a new treatment called giredestrant for individuals with Grade 1 endometrioid endometrial cancer. Researchers aim to evaluate how well this treatment works on its own and how it moves through the body. The study seeks participants who have not yet received cancer treatment and have a tumor that hasn't spread deeply or outside the uterus. Participants should be prepared to take oral medication and commit to six cycles of treatment. As a Phase 2 trial, the research focuses on measuring the treatment's effectiveness in an initial, smaller group, offering participants the opportunity to contribute to significant advancements in cancer treatment.

Do I have to stop taking my current medications for the trial?

The trial requires that you have not received any treatment for cancer, including chemotherapy, immunotherapy, or endocrine therapy, within 28 days before starting the study. Additionally, you should not take strong CYP3A4 inhibitors or inducers within 14 days before the study. If you are on these medications, you may need to stop them before participating.

Is there any evidence suggesting that giredestrant is likely to be safe for humans?

Research has shown that giredestrant appears safe for patients. In one study, a patient with recurring, spreading endometrial cancer remained healthy and maintained a good quality of life for about 57 months while taking giredestrant. This suggests the treatment is easy to tolerate over a long period.

Additionally, studies examining giredestrant combined with other drugs, like everolimus, found it helped slow disease progression. These studies not only assess its effectiveness but also provide important safety information, indicating that side effects are manageable.

This treatment is currently in a Phase 2 trial, which is crucial for understanding its safety and effectiveness in a larger group. While more information is needed, results so far suggest that giredestrant is generally well-tolerated in humans. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Researchers are excited about Giredestrant for endometrial cancer because it represents a novel approach compared to standard treatments like surgery, radiation, and chemotherapy. Giredestrant is unique as it works by selectively targeting and modulating estrogen receptors, which are often involved in the growth of endometrial cancer cells. Unlike traditional treatments that may affect both cancerous and healthy cells, Giredestrant offers a more targeted mechanism of action, potentially leading to fewer side effects and better outcomes. This precision in targeting cancer cells is what makes Giredestrant a promising option and a source of enthusiasm in the medical community.

What evidence suggests that giredestrant might be an effective treatment for endometrial cancer?

Research has shown that giredestrant may help treat certain cancers. In studies on ER-positive advanced breast cancer, giredestrant significantly improved progression-free survival, allowing patients to live longer without their cancer worsening. This drug blocks estrogen receptors, which can slow or stop the growth of some cancer cells. While evidence for its use in endometrial cancer is still developing, the success in breast cancer offers hope for its potential effectiveness. This ongoing study will determine its specific effectiveness for endometrial cancer, as participants in this trial will receive giredestrant. ^{1 2 6 7 8}

Who Is on the Research Team?

Clinical Trials

Principal Investigator

Hoffmann-La Roche

Are You a Good Fit for This Trial?

This trial is for individuals with Grade 1 endometrioid endometrial cancer who haven't had prior treatment and are willing to undergo six cycles of Giredestrant therapy. Participants should have a life expectancy of at least 12 weeks, be able to take oral medications, and have no evidence of deep tumor invasion or disease outside the uterus. Women must agree to avoid pregnancy during the study.

Inclusion Criteria

My blood and organs are functioning well.

MRI or computed tomography (CT)-confirmation of no extrauterine disease

I have not received any treatment for endometrial cancer.

Exclusion Criteria

I haven't taken strong CYP3A4 drugs recently.

Treatment with investigational therapy within 28 days prior to study enrollment

I don't have any health issues that would make it unsafe for me to try a new drug.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive giredestrant monotherapy

6 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Giredestrant

Trial Overview The study tests Giredestrant's effectiveness, safety, and how it's processed by the body in patients with early-stage endometrial cancer. It's a global Phase II trial where all participants receive Giredestrant as a single-agent therapy over six cycles before any surgical decision.

How Is the Trial Designed?

Group I: Giredestrant Experimental Treatment 1 Intervention

Who Is Running the Clinical Trial?

Hoffmann-La Roche

Lead Sponsor

Trials

2,482

Recruited

1,107,000+

Headquarters

Basel, Switzerland

Known For

Precision medicine

Top Products

Avastin, Herceptin, Rituxan, Accu-Chek

Dr. Levi Garraway

Hoffmann-La Roche

Chief Medical Officer since 2019

MD from the University of Basel

Dr. Thomas Schinecker

Hoffmann-La Roche

Chief Executive Officer since 2023

PhD in Molecular Biology from New York University

Published Research Related to This Trial

A 71-year-old woman with recurrent, metastatic endometrial cancer experienced significant clinical stability and a good quality of life for approximately 57 months while treated with a combination of tamoxifen and megestrol acetate, highlighting the potential effectiveness of this endocrine therapy.

This case suggests that combination endocrine therapy can be a viable treatment option for patients with recurrent, ER/PR-positive endometrial cancer, offering substantial long-term benefits with minimal side effects, even after multiple prior treatments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Case report: prolonged durable clinical benefit and low toxicity from combination endocrine therapy in a patient with recurrent endometrial carcinoma. Cheng, JM., Gaillard, S., Beavis, AL., et al.[2023]

Endometrial cancer has a better prognosis when detected early, but for recurrent or metastatic cases, the median survival is only about 12 months, highlighting the need for effective treatment options.

Recent trials show that combining doxorubicin, cisplatin, and paclitaxel significantly improves response rates and overall survival compared to the standard doxorubicin plus cisplatin regimen, suggesting a more effective approach for treating advanced endometrial cancer.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Chemotherapy in endometrial cancer. Obel, JC., Friberg, G., Fleming, GF.[2007]

Progesterone therapy shows overall response rates of 11% to 25% in well-differentiated endometrioid-type tumors, but its effectiveness can be limited by the down-regulation of progesterone receptors, suggesting a need for strategies to enhance receptor expression.

Chemotherapy combinations, particularly doxorubicin and cisplatin, yield response rates of 34% to 60%, with the addition of paclitaxel improving outcomes but increasing toxicity; ongoing studies are comparing this regimen to a less toxic alternative with carboplatin.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Old and new perspectives in the pharmacological treatment of advanced or recurrent endometrial cancer: Hormonal therapy, chemotherapy and molecularly targeted therapies. Gadducci, A., Cosio, S., Genazzani, AR.[2007]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT05634499

A Study of Giredestrant in Participants With Grade 1 ... This Phase II, global, single-arm study is designed to evaluate the efficacy, safety, and pharmacokinetics of giredestrant monotherapy in participants with ...

2. genentech-clinicaltrials.com genentech-clinicaltrials.com/en/trials/cancer/endometrial-cancer/a-study-of-giredestrant-in-participants-with-grade-1-en-08530.html

Clinical trial for Endometrial Cancer-Genentech A Member ... A study to look at how well giredestrant works in people with Stage 1, Grade 1 endometrial cancer , how safe giredestrant is and how the body processes it.

3. roche.com roche.com/media/releases/med-cor-2025-09-22

Positive phase III results show Roche's giredestrant ... Positive phase III results show Roche's giredestrant significantly improved progression-free survival in ER-positive advanced breast cancer.

4. onclive.com onclive.com/view/dr-mayer-on-efficacy-data-with-giredestrant-plus-everolimus-in-er-her2-breast-cancer

Dr Mayer on Efficacy Data With Giredestrant Plus ... Erica L. Mayer, MD, MPH, discusses primary efficacy outcomes for giredestrant in the phase 3 evERA trial in ER-positive, HER2-negative advanced ...

5. clinicaltrials.eu clinicaltrials.eu/inn/giredestrant/

Giredestrant: A Promising New Treatment for Breast Cancer Giredestrant shows promise as a potential new treatment option for patients with ER-positive, HER2-negative breast cancer. Ongoing research is exploring its ...

6. roche.com roche.com/media/releases/med-cor-2025-10-18

Roche's phase III evERA data showed giredestrant ... Giredestrant plus everolimus reduced the risk of disease progression or death by 44% and 62% in ITT and ESR1-mutated populations, ...

7. withpower.com withpower.com/trial/phase-2-endometrial-neoplasms-2023-9cf16

Giredestrant for Endometrial Cancer (EndomERA Trial) A 71-year-old woman with recurrent, metastatic endometrial cancer experienced significant clinical stability and a good quality of life for approximately 57 ...

8. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10854647/

Oral SERD, a Novel Endocrine Therapy for Estrogen ... Note that this higher suppression continued up to surgery with giredestrant with palbociclib (−81% (95% CI: −86%, −75%)) versus anastrozole with ...