Study Details

Open

NRG-GY026: Testing the addition of HERCEPTIN HYLECTA or PHESGO to the usual chemotherapy for HER2 positive endometrial serous carcinoma or carcinosarcoma

The purpose of this study is 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.

Age & Gender

18 years ~ 99 years
Female

Visit Availability

Standard business hours (M-F, 8-5)
Visits can be combined with regular clinical appointments

Location

North Carolina (Statewide)

What will be asked of you

This study aims to treat your cancer and closely resembles routine care that would be received regardless of participating on a research study. To participate on the study, you will frequently meet with a member of the study team in addition to your oncology care team. This study has 3 treatment groups, a computer will be used to assign you to one of the study groups. The study involves visits with your doctor, blood tests (blood count and chemistry) , Echocardiogram (ECHO) or multigated acquisition (MUGA) of your heart; CT scans, administration of study drugs; completion of questionnaires.

Incentives

In-person visits:
6-18

Total length of participation:
up to 5 years

Looking for Specific Volunteers

Able to participate:

You have been diagnosed with endometrial serous carcinoma or endometrial carcinosarcoma
You have endometrial tumors that are HER2 positive
You have not received chemotherapy for your cancer
You have recently had surgery in the last 8 weeks for your cancer or had an endometrial biospy without having a hysterectomy before study entry

Not eligible if:

You have received prior chemotherapy for your endometrial cancer
You have received prior radiation treatment for your endometrial cancer
You have a planned surgery for your cancer or hysterectomy, prior to documentation of progression, after entry into the study
You have a significant cardiovascular disease
You are unwilling to discontinue nursing your child

Contact the Team

Visit Location

Contact & Visit Location

Primary Contact

Lineberger Clinical Research
cancerclinicaltrials@med.unc.edu
(919) 966-4432

Primary Visit Location

NC Cancer Hospital (Basnight)
UNC Hospitals / UNC Medical Center
101 Manning Dr, Chapel Hill, NC 27514, USA

Additional Study Information

Principal Investigator

Linda Van Le
LCCC - Clinical Trials

Study Type

Clinical or Medical
Interventional

Study Topics

Cancer (Uterine (endometrial))

IRB Number

22-2552

ClinicalTrials.gov

NCT05445778