NRG-GY026

A Phase 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

Disease Site

Gynecologic [GY] Uterine Corpus

Phase

III

Developmental Therapeutics

No

Primary Objective

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