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

Trial Summary

What is the purpose of this trial?

This Phase II, global, single-arm study is designed to evaluate the efficacy, safety, and pharmacokinetics of giredestrant monotherapy in participants with Grade 1 endometrioid endometrial cancer.

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.

How is the drug Giredestrant unique for treating endometrial cancer?

Giredestrant is unique because it targets estrogen receptors, which are involved in the growth of some endometrial cancers, potentially offering a new approach compared to traditional chemotherapy and hormonal therapies that have limited effectiveness and significant side effects. ^{1 2 3 4 5}

Research Team

Clinical Trials

Principal Investigator

Hoffmann-La Roche

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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

Findings from Research

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]

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]

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Chemotherapy in endometrial cancer. [2007]

2. India pubmed.ncbi.nlm.nih.gov

Effectiveness of Megestrol for the Treatment of Patients with Atypical Endometrial Hyperplasia or Endometrial Endometrioid Adenocarcinoma (Stage IA, Well Differentiated). [2022]

3. United States pubmed.ncbi.nlm.nih.gov

G protein-coupled estrogen receptor-selective ligands modulate endometrial tumor growth. [2022]

4. Switzerland 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. [2023]

5. Netherlands 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. [2007]