About this trial
This trial looks at whether adding two medicines, Herceptin Hylecta and Phesgo, to standard chemotherapy helps shrink tumors in patients with a specific type of endometrial cancer called HER2 positive endometrial cancer. The goal is to see if these medicines can improve treatment outcomes compared to chemotherapy alone. The study focuses on patients with stage I to IV cancer.
The trial's ID number is NCT05256225. This is a Phase 3 trial, meaning it is looking at how well the treatments work and how safe they are. It is FDA-regulated and aims to include about 360 participants.
Who can join
Women age 18 and older with HER2 positive endometrial cancer that has not been treated before can join. They should have measurable disease or stable disease after surgery. Certain types of endometrial cancer are included, while those with some specific characteristics, like mismatch repair deficiency, cannot join. The trial team will confirm eligibility.
Conditions
Endometrial Carcinoma, Endometrial Clear Cell Adenocarcinoma, Endometrial Dedifferentiated Carcinoma, Endometrial Endometrioid Adenocarcinoma, Endometrial Mixed Cell Adenocarcinoma, Endometrial Serous Adenocarcinoma, Endometrial Undifferentiated Carcinoma, Uterine Corpus Malignant Mixed Mesodermal (Mullerian) Tumor
Age group
Adult, Older adult
The study team makes the final call on eligibility.
What happens in the study
Participants will be placed into one of three groups by chance. One group will receive standard chemotherapy (paclitaxel and carboplatin). The second group will get the same chemotherapy plus Herceptin Hylecta. The third group will receive chemotherapy plus Phesgo. Everyone will have regular check-ups and may undergo tests and procedures throughout the study.
Where
This trial is running at 408 locations.
University of Alabama at Birmingham Cancer Center
Birmingham, Alabama
Alaska Women's Cancer Care
Anchorage, Alaska
Banner University Medical Center - Tucson
Tucson, Arizona
University of Arizona Cancer Center-North Campus
Tucson, Arizona
University of Arkansas for Medical Sciences
Little Rock, Arkansas
Sutter Auburn Faith Hospital
Auburn, California
Alta Bates Summit Medical Center-Herrick Campus
Berkeley, California
John Muir Medical Center-Concord
Concord, California
The first 8 of 408 sites are listed here. The registry record has the full list.