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Upstate Active Clinical Trials

Study Title:

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-zzfx (PHESGO) in HER2 positive, stage I-IV endometrial serous carcinoma or carcinosarcoma. (#NCT05256225)

What is the purpose of the study? (in Layman's terms, please describe the study)

This study is being done to answer the following question:
Can we lower the chance of your endometrial cancer coming back and causing death by adding a
drug or drugs that target HER2 proteins in addition to the usual combination of chemotherapy
drugs?
We are doing this study because we want to find out if this approach is better or worse than the
usual approach for your endometrial cancer. The usual approach is defined as care most people
get for endometrial cancer. There is evidence that drugs that target HER2 are effective in shrinking your type of cancer and
preventing it from coming back. It is not possible to know now if drugs that target HER2 will
extend your life compared to the usual approach. This study will help the study doctors learn
things that will help people in the future.

Upstate Institutional Review Board (IRB) Number:

1980550

Study/Protocol ID:

NRG-GY026

Study Phase:

ll/lll

Patient Age Group:

Adults

Principal Investigator:

Mary J Cunningham, MD

What is involved if I participate?

  • How long is the study?
    5 years
  • Is transportation provided or reimbursed?
    No
  • Is parking provided or reimbursed?
    No
  • What tests and procedures are involved?
    HER2 testing report, History and physical, vital signs, performance status, CBC/Differential/Platelets, Chemistries (BUN or UREA, creatinine, sodium, potassium, chloride, CO2, calcium, glucose, total bilirubin, total protein, albumin, alkaline phosphatase, AST, ALT), Echocardiogram or MUGA, ECG, pregnancy test, Radiographic Tumor Measurement, Patient reported outcomes, biospecimen tissue and whole blood.

Where will the study take place?

Cancer center, Madison Irving.

Other Information:

All patients must have tumors that are HER2 positive.

ClinicalTrials.Gov ID:

#NCT05256225

For more information about this trial go to ClinicalTrials.Gov

Who can I contact for more information?

Name: Sonia Masood
Phone: 315-464-8232
Email: [email protected]

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