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Clinical trialNCT05256225RecruitingPhase 3Interventional

Testing the Addition of Herceptin Hylecta or Phesgo to the Usual Chemotherapy for HER2 Positive Endometrial Serous Carcinoma or Carcinosarcoma

SponsorNational Cancer Institute (NCI)Enrollment360Endometrial CarcinomaEndometrial Clear Cell AdenocarcinomaEndometrial Dedifferentiated CarcinomaEndometrial Endometrioid AdenocarcinomaEndometrial Mixed Cell AdenocarcinomaEndometrial Serous Adenocarcinoma+2 more conditions
View the registry record on ClinicalTrials.gov

Summary

The lay summary the sponsor registered on ClinicalTrials.gov.

This phase III trial tests whether adding trastuzumab and hyaluronidase-oysk (Herceptin Hylecta \[TM\]) or pertuzumab, trastuzumab and hyaluronidase-zzxf (Phesgo \[TM\]) to the usual chemotherapy (paclitaxel and carboplatin) works to shrink tumors in patients with HER2 positive endometrial cancer. Trastuzumab and pertuzumab are monoclonal antibodies and forms of targeted therapy that attach to specific molecules (receptors) on the surface of tumor cells, known as HER2 receptors. When trastuzumab or pertuzumab attach to HER2 receptors, the signals that tell the cells to grow are blocked and the tumor cell may be marked for destruction by the body's immune system. Hyaluronidase is an endoglycosidase. It helps to keep pertuzumab and trastuzumab in the body longer, so that these medications will have a greater effect. Hyaluronidase also allows trastuzumab and trastuzumab/pertuzumab to be given by injection under the skin and shortens their administration time compared to trastuzumab or pertuzumab alone. Paclitaxel is a taxane and in a class of medications called antimicrotubule agents. It stops tumor cells from growing and dividing and may kill them. Carboplatin is in a class of medications known as platinum-containing compounds. It works in a way similar to the anticancer drug cisplatin, but may be better tolerated than cisplatin. Carboplatin works by killing, stopping or slowing the growth of tumor cells. Giving Herceptin Hylecta or Phesgo in combination with paclitaxel and carboplatin may shrink the tumor and prevent the cancer from coming back in patients with HER2 positive endometrial cancer.

Investigators

The overall officials registered on this study. Names that resolve to a FindMyKOL profile link to it; the rest are shown as registered.

A profile link is shown only when the registered name resolves to a person record with a confident, namesake-checked match; ambiguous names stay unlinked.

Sites

414 registered facilities, with the per-site recruitment status where the registry publishes one. ClinicalTrials.gov does not publish per-site enrollment counts.

Puerto Rico
  • Centro Comprensivo de Cancer de Upr

    San Juan, Puerto Rico

    Luis J. Santos Reyes
    Recruiting
South Korea
  • Keimyung University-Dongsan Medical Center

    Dalseo-gu, Daegu, South Korea

    Suspended
  • Samsung Changwon Hospital

    Seoul, Gyeongsangnam-do, South Korea

    Suspended
  • Seoul National University Bundang Hospital

    Seongnam, Kyeonggi-do, South Korea

    Kidong Kim
    Recruiting
  • Gangnam Severance Hospital

    Seoul, South Korea

    Suspended
United States
  • University of Alabama at Birmingham Cancer Center

    Birmingham, Alabama, United States

    Michael D. Toboni
    Recruiting
  • Alaska Women'S Cancer Care

    Anchorage, Alaska, United States

    Dan S. Zuckerman
    Recruiting
  • Banner University Medical Center - Tucson

    Tucson, Arizona, United States

    Setsuko K. Chambers
    Recruiting
  • University of Arizona Cancer Center-North Campus

    Tucson, Arizona, United States

    Setsuko K. Chambers
    Recruiting
  • University of Arkansas for Medical Sciences

    Little Rock, Arkansas, United States

    Heather R. Williams
    Recruiting
  • Sutter Auburn Faith Hospital

    Auburn, California, United States

    John K. Chan
    Recruiting
  • Alta Bates Summit Medical Center-Herrick Campus

    Berkeley, California, United States

    John K. Chan
    Recruiting
  • John Muir Medical Center-Concord

    Concord, California, United States

    Active, not recruiting
  • City of Hope Comprehensive Cancer Center

    Duarte, California, United States

    Active, not recruiting
  • City of Hope Seacliff

    Huntington Beach, California, United States

    Active, not recruiting
  • City of Hope at Irvine Lennar

    Irvine, California, United States

    Active, not recruiting
  • Kaiser Permanente-Irvine

    Irvine, California, United States

    Scott E. Lentz
    Recruiting
  • Uci Health - Chao Family Comprehensive Cancer Center and Ambulatory Care

    Irvine, California, United States

    Krishnansu S. Tewari
    Recruiting
  • City of Hope at Long Beach Elm

    Long Beach, California, United States

    Active, not recruiting
  • Kaiser Permanente Los Angeles Medical Center

    Los Angeles, California, United States

    Scott E. Lentz
    Recruiting
  • Memorial Medical Center

    Modesto, California, United States

    John K. Chan
    Recruiting
  • Palo Alto Medical Foundation-Gynecologic Oncology

    Mountain View, California, United States

    John K. Chan
    Recruiting
  • Saint Joseph Hospital - Orange

    Orange, California, United States

    Madhavi Mummaneni
    Recruiting
  • Uc Irvine Health/chao Family Comprehensive Cancer Center

    Orange, California, United States

    Krishnansu S. Tewari
    Recruiting
  • Stanford Cancer Institute Palo Alto

    Palo Alto, California, United States

    Kristin L. Bixel
    Recruiting
  • Kaiser Permanente - Panorama City

    Panorama City, California, United States

    Scott E. Lentz
    Recruiting
  • Kaiser Permanente-Riverside

    Riverside, California, United States

    Scott E. Lentz
    Recruiting
  • Sutter Roseville Medical Center

    Roseville, California, United States

    John K. Chan
    Recruiting
  • Sutter Medical Center Sacramento

    Sacramento, California, United States

    John K. Chan
    Recruiting
  • University of California Davis Comprehensive Cancer Center

    Sacramento, California, United States

    Rebecca A. Brooks
    Recruiting
  • California Pacific Medical Center-Pacific Campus

    San Francisco, California, United States

    John K. Chan
    Recruiting
  • Palo Alto Medical Foundation-Santa Cruz

    Santa Cruz, California, United States

    John K. Chan
    Recruiting
  • Palo Alto Medical Foundation-Sunnyvale

    Sunnyvale, California, United States

    John K. Chan
    Recruiting
  • City of Hope Upland

    Upland, California, United States

    Active, not recruiting
  • John Muir Medical Center-Walnut Creek

    Walnut Creek, California, United States

    Babak Edraki
    Recruiting
  • Uchealth University of Colorado Hospital

    Aurora, Colorado, United States

    Marisa R. Moroney
    Recruiting
  • Adventhealth Porter

    Denver, Colorado, United States

    Neil T. Phippen
    Recruiting
  • Uchealth - Cherry Creek

    Denver, Colorado, United States

    Marisa R. Moroney
    Recruiting
  • Grand Valley Oncology

    Grand Junction, Colorado, United States

    Jonathan D. King
    Recruiting
  • Banner North Colorado Medical Center

    Greeley, Colorado, United States

    Robin A. Lacour
    Recruiting
374 more sites on the registry record.ClinicalTrials.gov ↗

Site investigator names are published by ClinicalTrials.gov only while a study recruits, so completed studies list sites without them.

Drugs studied

The drug and biological interventions registered on this study, normalized to their RxNorm ingredient where possible.

Linked drugs open the directory filtered to KOLs working with them.clinicaltrials.gov ↗

Registration & key dates

Registry attributes as recorded on the ClinicalTrials.gov study record.

Start
16 Nov 2022
Primary completion
31 Oct 2027
Completion
31 Oct 2027
Last update posted
19 Aug 2026
Registered enrollment
360
Registry id
NCT05256225

Source: ClinicalTrials.gov, via the CTTI AACT database, data as of 24 Aug 2026. Registry facts are shown as registered by the study sponsor; FindMyKOL does not interpret them.