NRG-GY026: a Phase 2/3 Study of Paclitaxel/Carboplatin Alone or Combined With Either Trastuzumab and Hyaluronidase-oysk (herceptin hylecta) or Pertuzumab, Trastuzumab and Hyaluronidase-zzxf in HER2-positive, Stage I-IV in Endometrial Cancer Patients
About
Phase 2/3, three-arm, randomized superiority study to test the efficacy of the standard of care to the experimental arms for HER2+ endometrial serous carcinoma and endometrial carcinosarcoma. Patients to be within 8 weeks of cancer diagnosis or surgical resection. Enrolled patients will be naïve to treatment for their newly diagnosed cancer. Patients will be randomized in a 1:1:1 fashion to the below treatment arms:
- Arm 1: paclitaxel/carboplatin every 3 weeks for 6 cycles
- Arm 2: paclitaxel/carboplatin/trastuzumab/Herceptin Hylecta every 3 weeks for 6 cycles, followed by maintenance Herceptin Hylecta every 3 weeks for 1 year
- Arm 3: paclitaxel/carboplatin/pertuzumab/trastuzumab/PHESGO every 3 weeks for 6 cycles, followed by maintenance PHESGO every 3 weeks for 1 year.
Eligibility Criteria
Inclusion Criteria
- Stage IA-IVB, non-recurrent, chemo-naïve, HER2-positive endometrial serous carcinoma or endometrial carcinosarcoma.
- Histologic confirmation of the original primary tumor is required.
- Patients must be within 8 weeks of primary surgery (or endometrial biopsy in patients who never undergo hysterectomy) at the time of study registration.
- For patients with uterine-confined (stage I) disease, the tumor must be invasive into the myometrium.
- Any amount of myoinvasion is acceptable for eligibility. Patients with non-invasive disease, endometrial intraepithelial carcinoma alone, or disease confined to a polyp will be excluded.
- All patients must have tumors that are HER2 positive as defined by ASCO/CAP 2018 Breast Cancer guidelines
- Age ≥ 18.
Exclusion Criteria
- Patients must NOT have received prior chemotherapy, biologic therapy or targeted therapy for treatment of endometrial carcinoma.
- Patients must NOT have received prior radiation therapy for treatment of endometrial carcinoma. Prior radiation includes external beam pelvic radiation therapy, external beam extended field pelvic/para-aortic radiation therapy and/or intravaginal brachytherapy.
- Significant cardiovascular disease, including uncontrolled hypertension, myocardial infarction or unstable angina and/or serious cardiac arrhythmia requiring medication. This does not include asymptomatic atrial fibrillation with controlled ventricular rate.
- Significant lung disease: dyspnea at rest grade 2 or greater, pneumonitis grade 2 or greater, interstitial lung disease grade 2 or greater, idiopathic pulmonary fibrosis, cystic fibrosis, Aspergillosis, active tuberculosis or history of opportunistic infections (pneumocystis pneumonia or cytomegalovirus pneumonia).
- Patients with uncontrolled intercurrent illness, including but not limited to ongoing or active infection (except for uncomplicated urinary tract infection), uncontrolled interstitial lung disease, symptomatic congestive heart failure or psychiatric illness/social situations that would limit compliance with study requirements.
Primary Investigator
Dr. Janet Osborne is a Gynecologic Oncologist with more than two decades of clinical and research experience. She is board certified by the American Board of Obstetrics and Gynecology in Gynecologic Oncology. She completed her fellowship at the University of Michigan and her internship and residency at the University of Minnesota Hospital and Clinics.
Contact Information
Katie Church, MS, MA
Clinical Research Coordinator
