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Active Not Recruiting
NCT05634499
A Study of Giredestrant in Participants With Grade 1 Endometrial Cancer
Conditions: Endometrial Cancer
Sex: Female
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: PHASE2
Enrollment: 30
Sponsor: Hoffmann-La Roche
Location: University of Arkansas for Medical Sciences Little Rock Arkansas
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.
Eligibility Criteria
Inclusion Criteria:
* 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 (\
Source: ClinicalTrials.gov (NCT05634499). StuddyBuddy aggregates publicly available trial information.
