NRG-GY026: 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
Categories (click each to see list of all clinical trials associated with that category): Gyn/Onc (OB/GYNONC)
Current Status: Open
Phase: II/III (Cancer Control)
Principal Investigator: Rodabaugh, Kerry
Contact Information:
Pamela Nielsen
pnielsen@nebraskamed.com
Eligibility: https://clinicaltrials.gov/ct2/show/NCT05256225?term=NCT05256225&draw=2&rank=1#eligibility
Summary
Primary Objective
1.1.1 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.
1.1.2 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 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.
Secondary Objectives
1.2.1 To evaluate the overall response rate (ORR) in patients with measurable disease. The ORR will be defined as the binomial proportion of evaluable patients with a best overall response of CR or PR (by RECIST 1.1) within 12 months of initiating maintenance therapy.
1.2.2 To evaluate the duration of objective response in patients with measurable disease as assessed by RECIST 1.1.
1.2.3 To determine the nature, frequency and degree of toxicity as assessed by CTCAE v.5.0 for each treatment arm.
1.2.4 To compare QOL, as measured by FACT-En-TOI, in the experimental versus control arms.
1.2.5 To compare patient-reported treatment-associated symptoms (diarrhea and rash) as measured with the PRO -CTCAE, patient-reported fatigue as measured with the PROMIS-Fatigue short form, and worry concerning side effects of treatment as measured by the item 'bothered by side effect', in the FACT-En TOI, respectively, in the experimental
and control arms.
1.2.6 To assess the correlation of HER2 IHC expression and ISH amplification with clinical
outcome and response to HER2 targeted therapies.
1.3 Exploratory Objectives
1.3.1 To explore time to sustained deterioration in quality of life, as measured by a drop in the FACT-En-TOI by 6 or more points lasting for more than one PRO time point, in the experimental and control arms.