Endometrial Trial - NRG GY026

Status:

Recruiting

Disease Site:

Endometrial

Phase:

Phase II, Phase III

Official Title:

NRG GY026, A Phase II/III Study of Carbo/Taxol 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

NCT ID:

NCT#05256225

Link to Full Details:

clinicaltrials.gov/show/NCT05256225

Description:

This phase II/III trial tests whether adding trastuzumab and hyaluronidase-oysk (Herceptin HylectaTM) or pertuzumab, trastuzumab and hyaluronidase-zzxf (PhesgoTM) to the usual chemotherapy (paclitaxel and carboplatin) works to shrink tumors in patients with HER2 positive endometrial serous carcinoma or carcinosarcoma.

Eligibility:

Female – 18 years and older

Inclusion Criteria:

IA-IVB, Non-Recurrent, Chemo-Naïve, Serous or Carcinosarcoma
HER2 Positive based on local results
Must be within 8 weeks of primary surgery (or endometrial bx in pts who never undergo hysterectomy)

Exclusion Criteria:

Planned interval cytoreduction or hysterectomy, prior to documentation of progression, after study registration
No external beam RT, prior to documentation of progression, after study registration