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Endometrial CancerPhase 2EndomERANCT05634499

A Study of Giredestrant in Participants With Grade 1 Endometrial Cancer

A Phase 2 study testing Giredestrant in people with Endometrial Cancer, run by Hoffmann-La Roche at 11 sites in 4 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older, women only
Conditions the study is for
Endometrial Cancer
What is being tested?
Giredestrant
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
33 participants
Where
11 sitesin 4 countries
Study dates
27 Jun 2023to 25 Aug 2026
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Confirmed Grade 1 endometrial cancer (EC) of endometrioid histology for which participants are willing to receive 6-cycles of study therapy. An endometrial biopsy (EMB) or dilation and curettage (D\&C) fresh collected within the screening period or archival sample collected within 3 months prior to screening must be provided to a central laboratory for histologic confirmation to determine eligibility.
  • Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1
  • Magnetic resonance imaging (MRI)-confirmation of non-deeply invasive tumor (<50% myometrial invasion)
  • MRI or computed tomography (CT)-confirmation of no extrauterine disease
  • Willing to undergo a minimum of 6 continuous cycles of therapy before decision on surgery
  • No prior treatment for endometrial cancer
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  • Able and willing to take oral medications
  • Willingness and ability to comply with scheduled visits, treatment plans, laboratory tests, and other study procedures
  • Adequate hematologic and end-organ function, as defined in the protocol
  • Negative HIV test at screening, with the following exception: Patients with a positive HIV test at screening are eligible provided they are stable on anti-retroviral therapy, have a CD4 count ≥200/μL, and have an undetectable viral load.
  • For female participants of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraception, and agree to refrain from donating eggs, during the treatment period and for 30 days after the final dose of giredestrant, as defined in the protocol

Who cannot join

  • Pregnancy or breastfeeding, or intention of becoming pregnant during the study or within 30 days after the final dose of giredestrant or within the time period specified per local prescribing guidelines after the final dose of the investigator's choice of endocrine therapy
  • Participants with non-endometrioid histologies, such as serous, clear cell, and mixed
  • Treatment with investigational therapy within 28 days prior to initiation of study enrollment
  • Treatment for cancer including but not limited to, chemotherapy, immunotherapy, cyclin-dependent kinase (CDK)4/6 inhibitors, endocrine therapy, biologic therapy, or herbal therapy within 28 days prior to the initiation of study enrollment
  • Any gastrointestinal condition causing malabsorption or obstruction (e.g., celiac sprue, gastric bypass surgery, strictures, adhesions, history of small bowel resection, blind loop syndrome)
  • Known hypersensitivity to giredestrant or its excipients
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  • Known intercurrent illness or psychiatric illness/social situations that will limit compliance with study requirements
  • Evidence or high suspicion of metastatic/extrauterine disease at enrollment
  • Unwilling or unable to comply with study-related procedures, including all endometrial sampling/biopsies
  • Planned surgery, either for the treatment of cancer or any other surgery, during the study treatment period and up to 10 days after the completion of study treatment
  • Serious infections requiring IV antibiotics within 7 days prior to initiation of study treatment or any active infection that, in the opinion of the investigator, could impact participant safety
  • Participants who have clinically significant liver disease consistent with Child-Pugh Class B or C, including active hepatitis (e.g., hepatitis B virus [HBV] or hepatitis C virus [HCV]), current alcohol abuse, cirrhosis, or positive test for viral hepatitis, as defined in the protocol
  • Treatment with strong CYP3A4 inhibitors or inducers within 14 days or 5 drug elimination half-lives (whichever is longer) prior to initiation of study treatment
  • Any serious medical condition or abnormality in clinical laboratory tests that precludes the participant's safe participation in and completion of the study
  • History of other malignancy within 5 years prior to screening, except for those with an expected negligible risk for metastases or death (e.g., 5-year overall survival 90%) after curative treatment
  • Active tuberculosis
  • Severe infection per investigator judgment at the time of enrollment, including but not limited to, use of systemic antibiotics, hospitalization for complications of infection, bacteremia, or severe pneumonia, or any active infection that, in the opinion of the investigator, could impact participant safety
  • Significant cardiovascular disease, such as cardiac disease New York Heart Association Class II or greater, myocardial infarction, or cerebrovascular accident within 3 months prior to enrollment, unstable arrhythmias, or unstable angina
  • Active cardiac disease or history of cardiac dysfunction, as defined in the protocol
  • Major surgical procedure other than for diagnosis within 28 days prior to enrollment or anticipation of need for a major surgical procedure during the study
  • Prior allogeneic bone marrow transplantation or solid organ transplant
  • Any other diseases, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug or that may affect the interpretation of the results or renders the participant at high risk for treatment complications illnesses or conditions that interfere with the participant's capacity to understand, follow, and/or comply with study procedures

Trial locations and contacts

11 sites in 4 countries.

11 sites in 4 countries

United States6 sites

  • Englewood Health/Hematology Oncology Practice of Englewood (HOPE)

    Englewood, New Jersey, 07631

  • Texas Oncology, P.A. - Fort Worth

    Fort Worth, Texas, 76104

  • University of Arkansas for Medical Sciences

    Little Rock, Arkansas, 72205

  • Mount Sinai Medical Center

    Miami Beach, Florida, 33140

  • Minnesota Oncology Minneapolis

    Minneapolis, Minnesota, 55404

  • Western Pennsylvania Hospital

    Pittsburgh, Pennsylvania, 15224

Other trials in United States

Canada2 sites

  • Jewish General Hospital

    Montreal, Quebec, H3T 1E2

  • McGill University Health Centre - Glen Site

    Montreal, Quebec, H4A 3J1

Other trials in Canada

Poland2 sites

  • Narodowy Inst.Onkol.im.Sklodowskiej-Curie Panstw.Inst.Bad Gliwice

    Gliwice, 44-101

  • Swietokrzyskie Centrum Onkologii

    Kielce, 25-734

Other trials in Poland

Italy1 site

  • Istituto Scientifico Romagnolo Per Lo Studio E La Cura Dei Tumori IRST - PPDS

    Meldola, Emilia-Romagna, 47014

Other trials in Italy

About this study

Official title: A Phase II, Single-Arm Study of Giredestrant in Patients With Grade 1 Endometrial Cancer

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.

Being tested
Giredestrant
Medical subject headings
Endometrial Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • GiredestrantDrug

    Also called RO7197597, GDC-9545, RG6171

    Participants will receive giredestrant 30 milligrams (mg) taken orally (PO) once a day (QD) on Days 1 to 28 of each 28-day cycle for 6 cycles. After completion of 6 cycles, the participant and investigator can choose to continue study treatment for an additional 18 cycles or discontinue study treatment and receive investigator-determined care.

Study groups in NCT05634499
Study groupRoleWhat they receive
GiredestrantExperimentalNot described
Receives: Drug: Giredestrant

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Percentage of Participants Who Have Regression at 6 Months

    The percentage of participants who have regression is defined as participants who have a decrease in the proportion of cancer in their endometrial biopsy or the proportion of cancer is not increased, but there is an increase in non-cancer/non-atypical hyperplasia at the 6-month assessment compared with baseline.

    Measured: Baseline, 6 Months

  2. Number of Participants with at Least One Adverse Event, with Severity Determined According to the National Cancer Institute Common Terminology Criteria for Adverse Events, version 5.0 (NCI-CTCAE v5.0)

    Measured: From Baseline until 30 days after the final dose of study drug (up to 1 year, 6 months)

Secondary outcomes (5)

  1. Percentage of Participants Who Have Complete Regression at 6 Months

    The percentage of participants who have complete regression is defined as participants having an assessment of 100% of non-cancer/non-atypical hyperplasia at the Month 6 assessment.

    Measured: Baseline, 6 Months

  2. Median Duration of Regression

    Measured: From first regression to first relapse (up to 1 year, 6 months)

  3. Median Time to First Regression

    Measured: From first study treatment to first regression (up to 1 year, 6 months)

  4. Median Time to Relapse or Loss of Clinical Benefit

    Measured: From first study treatment to relapse or loss of clinical benefit, whichever occurs first (up to 1 year, 6 months)

  5. Plasma Concentration of Giredestrant at Specified Timepoints

    Measured: Predose on Day 1 of Cycles 1, 2, 3, 4, and 6; 3-4 hours Postdose on Day 1 of Cycles 1 and 2 (each cycle is 28 days)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Dec 2022
  2. Study start27 Jun 2023
  3. Primary completion25 Aug 2026
  4. Study completion25 Aug 2026

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
33 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05634499
Sponsor's protocol ID
CO44195
Other IDs
2022-002443-21, 2023-504091-23-00, 2023
Acronym
EndomERA
Status last verified
Sep 2026
First submitted
21 Nov 2022
Last updated
14 Sep 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: For eligible studies, qualified researchers may request access to individual patient level clinical data. See Roche's commitment to transparency of clinical study information here: https://go.roche.com/data\_sharing

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Giredestrant in people with Endometrial Cancer, run by Hoffmann-La Roche at 11 sites in 4 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 11 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 14 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 11 sites in United States, Canada, Poland, Italy. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of Participants Who Have Regression at 6 Months (time frame: Baseline, 6 Months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05634499.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Sep 2026.

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