NRG-GY026: Stage 1-IV Endometrial Serous Carcinoma or Carcinosarcoma - Clinical Trial
What is the Purpose of this Study?
We are doing this study to find out if adding drugs that target HER2 proteins to the standard therapy for endometrial cancer can improve the chance of remission or lower the risk that the cancer comes back after treatment. We want to know how well patients do on the standard treatment compared to two experimental study regimens.
What is the Condition Being Studied?
HER2+ Stage I-IV Endometrial Serous Carcinoma or Carcinosarcoma
Who Can Participate in the Study?
Adult females who:
- Are diagnosed with Stage IA-IVB, non-recurrent, HER2-positive endometrial serous carcinoma or endometrial carcinosarcoma
- Have not been treated with chemotherapy yet
For more information about who can join this study, please contact the study team at nick.jeffries@duke.edu.
Age Group
Adults
What is Involved?
If you decide to participate in this study, you will get an assignment to 1 of 3 groups:
- Group 1: You will get paclitaxel and carboplatin by infusion through a vein (IV) for 18 weeks (standard treatment)
- Group 2: You will get paclitaxel and carboplatin by infusion plus HERCEPTIN HYLECTA by injection under the skin (shots) for 18 weeks with the possibility of continuing for up to a year (study regimen)
- Group 3: You will receive paclitaxel and carboplatin by infusion plus PHESGO by injection under the skin for 18 weeks with the possibility of continuing for up to a year (study regimen)
Study Details
Full Title
NRG-GY026:A Phase II/III Study of Paclitaxel/Carboplatin Alone or Combined with Either Trastuzumab and Hyaluronidase-oysk (HERCEPTIN HYLECTA) or Pertuzumab, Trastuzumab, and Hyaluronidase-zzxf (PHESGO) in HER2 Positive, Stage I-IV Endometrial Serous Carcinoma or Carcinosarcoma
Principal Investigator
Gynecologic Oncologist
Protocol Number
IRB:
PRO00112611
NCT:
NCT05256225
Phase
Phase
II/III
ClinicalTrials.gov
View on ClinicalTrials.gov
Enrollment Status
Open for Enrollment