Full Title
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 (NRG-GY026) (CIRB)Purpose
This purpose of this study is to assess whether adding trastuzumab/hyaluronidase-oysk or pertuzumab/trastuzumab/hyaluronidase-zzxf to the usual chemotherapy (paclitaxel and carboplatin) shrinks tumors in patients with HER2-positive endometrial serous carcinoma or carcinosarcoma.
Hyaluronidase helps to keep pertuzumab and trastuzumab in the body longer so these medications will have a greater effect. Hyaluronidase also allows trastuzumab and trastuzumab/pertuzumab to be given by subcutaneous injection (under the skin) and shortens their administration time compared to trastuzumab or pertuzumab alone. Participants will be randomly assigned to receive one of these treatments:
- Paclitaxel and carboplatin (standard therapy)
- Paclitaxel and carboplatin plus trastuzumab/hyaluronidase-oysk
- Paclitaxel and carboplatin plus pertuzumab/trastuzumab/hyaluronidase-zzxf
Paclitaxel and carboplatin are given intravenously (by vein) and trastuzumab/hyaluronidase-oysk and pertuzumab/trastuzumab/hyaluronidase-zzxf are given as subcutaneous injections.
Who Can Join
To be eligible for this study, patients must meet several requirements, including:
- Participants must have HER2-positive endometrial serous carcinoma or endometrial carcinosarcoma.
- Patients may not have recurrent disease and may not have previously received chemotherapy. Cancer surgery must have been completed within 8 weeks of receiving the study therapy.
- Patients must be able to walk and do routine activities for more than half of their normal waking hours.
- This study is for people age 18 and older.
Contact
For more information and to ask about eligibility for this study, please contact the office of Dr. Carol Aghajanian at 646-888-4217.