Research & Innovation

Uterine Clinical Trials

Clinical Trials

NRG-GY026

Phase II/III Study of Paclitaxel/Carboplatin Alone or Combined with Either Trastuzumab and Herceptin Hylecta or Pertuzumab, Trastuzumab and PHESGO in HER2 Positive, Stage I-IV Endometrial Serous Carcinoma or Carcinosarcoma (NCT 05256225).

Physician & Study Coordinator

Study Coordinator

Janine Schippang
email: JanineL.Schippang@sluhn.org
phone: 484-658-1790

 

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Synopsis

This study is being done to compare the usual treatment alone to the usual treatment plus Herceptin Hylecta or PHESGO. The addition of trastuzumab / Herceptin Hylecta or trastuzumab / pertuzumab / PHESGO to the usual treatment could prevent your cancer from returning or shrink your cancer. This study will help the study doctors find out if the different approach is better, the same or worse than the usual approach. The usual approach is chemotherapy with two agents called paclitaxel and carboplatin.

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Eligibility Criteria

Your doctor will determine whether this clinical trial is an appropriate option for you. Some key eligibility criteria are as follows:

  • Treatment naïve (not previously treated) stage IA-IVB endometrial serous carcinoma or endometrial carcinosarcoma
  • All patients must have tumors that are HER2 positive (ex. 3+ by IHC, 2+ by ISH)
  • Patients may have measurable disease, non-measurable disease, or no measurable disease on CT or MRI imaging
  • For patients with uterine-confined (stage I) disease, the tumor must be invasive into the myometrium
  • Patients may not have received prior chemotherapy, biologic therapy, or targeted therapy for treatment of endometrial carcinoma
  • Patients may not have received prior radiation therapy for treatment of endometrial carcinoma
  • Vaginal brachytherapy for treatment of endometrial cancer is permitted during study treatment but must be determined at time of study registration

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