GIREDESTRANT for Endometrial cancer | Endometrial cancer stage I

Inclusion criteria

• {"criterion_text":"- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1\n- Confirmed Grade 1 endometrial carcinoma (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\n- Magnetic resonance imaging (MRI)-confirmation of non-deeply invasive tumor (<50% myometrial invasion)\n- MRI or computed tomography (CT)-confirmation of no extrauterine disease\n- Willing to undergo a minimum of 6 continuous cycles of therapy before decision on surgery\n- Adequate hematologic and end-organ function"}

Exclusion criteria

• {"criterion_text":"- 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\n- Treatment for cancer including but not limited to, chemotherapy, immunotherapy, cyclin-dependent kinase (CDK)4/6i, endocrine therapy, biologic therapy, or herbal therapy within 28 days prior to the initiation of study enrollment\n- Any gastrointestinal condition causing malabsorption or obstruction\n- 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\n- Participants who have clinically significant liver disease consistent with Child-Pugh Class B or C, including active hepatitis, current alcohol abuse, cirrhosis, or positive test for viral hepatitis\n- Any serious medical condition or abnormality in clinical laboratory tests that precludes the participant’s safe participation in and completion of the study"}

Primary endpoints

• {"endpoint_text":"- 1. Regression rate at Month 6 assessment, defined as participants who have a decrease in the proportion of cancer or percentage of cancer is not increased but have an increase in non-cancer/non-atypical hyperplasia (%) at the Month 6 assessment compared with baseline\n- 2. Occurrence and severity of adverse events with severity determined according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0","definition_or_measurement_approach":"1. Regression rate at Month 6 assessment defined by change from baseline in proportion/percentage of cancer and increase in non-cancer/non-atypical hyperplasia at Month 6; 2. Adverse events graded per NCI CTCAE v5.0"}

Secondary endpoints

• {"endpoint_text":"- 1. Complete regression rate, defined as the participants who have an assessment of 100% of non-cancer/non-atypical hyperplasia at Month 6 assessment\n- 2. Duration of regression, defined as the time from the first regression to time of the first relapse\n- 3. Time to regression, defined as the time from the first study treatment to the first regression\n- 4. Time to relapse or loss of clinical benefit per investigator, defined as the time from the first study treatment to relapse or loss of clinical benefit per investigator, whichever occurs first. Participants will be censored if they have surgery at Month 6 and no relapse or loss of clinical benefit occurs before surgery\n- 5. Plasma concentration of giredestrant at specified timepoints","definition_or_measurement_approach":"1. Complete regression = 100% non-cancer/non-atypical hyperplasia at Month 6; 2. Duration measured from first regression to first relapse; 3. Time from first study treatment to first regression; 4. Time from first study treatment to relapse or loss of clinical benefit (censoring rules applied for Month 6 surgery); 5. Plasma concentrations measured at specified PK timepoints"}

Italy

Earliest CTIS Part Ii Submission Date

17-02-2023

Latest Decision Or Authorization Date

10-10-2025

Processing Time Days

966

Number Of Sites

3

Number Of Participants

3

Poland

Earliest CTIS Part Ii Submission Date

17-02-2023

Latest Decision Or Authorization Date

10-10-2025

Processing Time Days

966

Number Of Sites

3

Number Of Participants

6

Primary sponsor

Full Name

F. Hoffmann-La Roche AG

Organisation Type

Pharmaceutical company

Country Of Registered Address

Switzerland

Contract research organisations

Name

IQVIA Limited

Responsibilities

Global CRO

Name

Parexel International (IRL) Limited

Third parties

• {"country":"United States","full_name":"Almac Clinical Technologies LLC","duties_or_roles":"Randomization","organisation_type":"Pharmaceutical company"}
• {"country":"Belgium","full_name":"CellCarta","duties_or_roles":"Speciality Laboratory","organisation_type":"Laboratory/Research/Testing facility"}
• {"country":"United States","full_name":"Labcorp Central Laboratory Services LP","duties_or_roles":"General Laboratory","organisation_type":"Pharmaceutical company"}
• {"country":"Switzerland","full_name":"Labcorp Central Laboratory Services SARL","duties_or_roles":"General Laboratory","organisation_type":"Pharmaceutical company"}
• {"country":"United States","full_name":"Labcorp Early Development Laboratories Inc.","duties_or_roles":"Speciality Laboratory","organisation_type":"Pharmaceutical company"}
• {"country":"United Kingdom","full_name":"IQVIA Limited","duties_or_roles":"Global CRO","organisation_type":"Pharmaceutical company"}
• {"country":"Ireland","full_name":"Parexel International (IRL) Limited","duties_or_roles":"","organisation_type":"Pharmaceutical company"}
• {"country":"United States","full_name":"Cellcarta Naperville LLC","duties_or_roles":"Speciality Laboratory","organisation_type":"Pharmaceutical company"}