Study: NCT05712941

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Lerociclib
Description: All participants should be treated according to the best-current-practice guidelines and standard of care within each institution or country where the study is conducted.~Participants will be randomized to receive either lerociclib (administered at 150 mg twice a day (BID) in combination with letrozole (administered at 2.5 mg once a day (QD), or placebo administered in combination with letrozole (2.5 mg QD).~Participants will also be stratified, using interactive response technology (IRT), by the following randomization strata:~* Endometrial Cancer (EC) tumor staging (Federation Internationale de Gynecologie et d'Obstetrique \[FIGO\] Stage III versus FIGO Stage IV versus recurrent)~* EC tumor grade (Grade 1 versus Grade 2)~* Geographic location (US versus Europe versus Rest of World)

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Letrozole 2.5mg
Description: All participants should be treated according to the best-current-practice guidelines and standard of care within each institution or country where the study is conducted.~Participants will be randomized to receive either lerociclib (administered at 150 mg twice daily (BID) in combination with letrozole (administered at 2.5 mg once a day (QD), or placebo administered in combination with letrozole (2.5 mg QD).~Participants will also be stratified, using interactive response technology (IRT), by the following randomization strata:~* Endometrial Cancer (EC) tumor staging (Federation Internationale de Gynecologie et d'Obstetrique \[FIGO\] Stage III versus FIGO Stage IV versus recurrent)~* EC tumor grade (Grade 1 versus Grade 2)~* Geographic location (US versus Europe versus Rest of World)

Intervention type: DRUG
Group type: PLACEBO_COMPARATOR
Intervention: Letrozole 2.5mg
Description: All participants should be treated according to the best-current-practice guidelines and standard of care within each institution or country where the study is conducted.~Participants will be randomized to receive either lerociclib (administered at 150 mg twice daily (BID) in combination with letrozole (administered at 2.5 mg once a day (QD), or placebo administered in combination with letrozole (2.5 mg QD).~Participants will also be stratified, using interactive response technology (IRT), by the following randomization strata:~* Endometrial Cancer (EC) tumor staging (Federation Internationale de Gynecologie et d'Obstetrique \[FIGO\] Stage III versus FIGO Stage IV versus recurrent)~* EC tumor grade (Grade 1 versus Grade 2)~* Geographic location (US versus Europe versus Rest of World)

Intervention type: DRUG
Group type: PLACEBO_COMPARATOR
Intervention: Placebo
Description: All participants should be treated according to the best-current-practice guidelines and standard of care within each institution or country where the study is conducted.~Participants will be randomized to receive either lerociclib (administered at 150 mg twice day (BID) in combination with letrozole (administered at 2.5 mg once a day (QD), or placebo administered in combination with letrozole (2.5 mg QD).~Participants will also be stratified, using interactive response technology (IRT), by the following randomization strata:~* Endometrial Cancer (EC) tumor staging (Federation Internationale de Gynecologie et d'Obstetrique \[FIGO\] Stage III versus FIGO Stage IV versus recurrent)~* EC tumor grade (Grade 1 versus Grade 2)~* Geographic location (US versus Europe versus Rest of World)