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
Britt Erickson, MD
Status
Open to Accrual
Date Opened To Accrual
August 12 2022
Disease Site
Gynecologic [GY]
Uterine Corpus
Phase
III
Developmental Therapeutics
No
Primary Objective
Phase II: Progression Free Survival
To evaluate the efficacy of trastuzumab and hyaluronidase-oysk (HERCEPTIN HYLECTA) and pertuzumab, trastuzumab, and hyaluronidase-zzxf (PHESGO) in combination with paclitaxel/carboplatin in patients with HER2 positive endometrial serous carcinoma or carcinosarcoma. Efficacy will be determined via investigator assessed progression free survival (PFS) as assessed by RECIST 1.1. The two experimental arms (Arms 2 and 3) will be compared to the reference arm (Arm 1). If the experimental arms demonstrate superiority to the reference, the experimental arms will be compared to each other.
Phase III: Overall Survival
To evaluate the efficacy of trastuzumab and hyaluronidase-oysk (HERCEPTIN HYLECTA) and pertuzumab, trastuzumab, and hyaluronidase-zzxf (PHESGO) in combination with paclitaxel/carboplatin in patients with HER2 positive endometrial serous carcinoma or carcinosarcoma. Efficacy will be determined via investigator assessed overall survival (OS). The two experimental arms (Arms 2 and 3) will be in patients with HER2 positive endometrial serous carcinoma or carcinosarcoma compared to the reference arm (Arm 1). If the experimental arms demonstrate superiority to the reference, the experimental arms will be compared to each other.
Patient Population
Patients with HER2 positive endometrial serous carcinoma or carcinosarcoma
Target Accrual
525