Phase III Trial of Adding Herceptin Hylecta or Phesgo to Paclitaxel and Carboplatin Chemotherapy for HER2 Positive Endometrial Serous Carcinoma or Carcinosarcoma

What this Trial Is About

This trial evaluates the addition of trastuzumab and hyaluronidase-oysk Herceptin Hylecta or pertuzumab, trastuzumab, and hyaluronidase-zzxf Phesgo to standard chemotherapy with paclitaxel and carboplatin in patients with HER2 positive endometrial cancer. The goal is to see if these combinations can better shrink tumors and improve outcomes by targeting HER2 receptors on cancer cells. This is a phase III trial involving women with specific types of endometrial cancer, including serous carcinoma and carcinosarcoma. Participants are randomly assigned to one of three treatment groups. One group receives paclitaxel and carboplatin alone. The second group receives paclitaxel, carboplatin, and trastuzumabhyaluronidase-oysk with possible maintenance therapy for up to 3 years. The third group receives paclitaxel, carboplatin, and pertuzumabtrastuzumabhyaluronidase-zzxf with similar maintenance. Treatments are given intravenously or by injection under the skin every 3 weeks in cycles lasting about 6 cycles, with additional cycles possible if disease remains stable or partially responsive. Throughout the study, participants undergo heart function tests echocardiography or MUGA and CT scans to monitor disease and side effects. Optional blood and urine samples may be collected, and vaginal brachytherapy may be administered. After treatment ends, participants are followed every 3 months for 2 years, then every 6 months for another 3 years. The study measures progression-free survival, overall survival, treatment side effects, tumor response, and quality of life over up to 5 years.

Testing the Addition of Herceptin Hylecta or Phesgo to the Usual Chemotherapy for HER2 Positive Endometrial Serous Carcinoma or Carcinosarcoma