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Addition of Trastuzumab or Trastuzumab/​Pertuzumab to the Usual Chemotherapy for HER2 Positive Endometrial Cancer

This phase II/III trial investigates if adding HerceptinHylecta™ (trastuzumab and hyaluronidase-oysk) or Phesgo™ (pertuzumab,trastuzumab, and hyaluronidase-zzxf) to standard chemotherapy (paclitaxel andcarboplatin) can help shrink tumors in patients with HER2 positive endometrialserous carcinoma or carcinosarcoma.

NCT05256225

  • Herceptin Hylecta™ (trastuzumab and hyaluronidase-oysk)
  • Phesgo™(pertuzumab, trastuzumab, and hyaluronidase-zzxf)
  • standardchemotherapy (paclitaxel and carboplatin)
  • Trastuzumab and pertuzumab aretypes of targeted therapy that block growth signals from reaching cancer cellsby attaching to HER2 receptors on their surface.
  • Hyaluronidase helps these drugsstay in the body longer and allows for quicker, under-the-skin injections.
  • Paclitaxel and carboplatin arechemotherapy drugs that kill or stop cancer cells from dividing.
  • This combination couldpotentially reduce tumor size and prevent cancer recurrence.
  • Phase II: To test how effective the combination of HERCEPTIN HYLECTA (trastuzumab and hyaluronidase-oysk) and PHESGO (pertuzumab, trastuzumab, and hyaluronidase-zzxf) with paclitaxel and carboplatin is in treating patients with HER2 positive endometrial serous carcinoma or carcinosarcoma.
  • Phase III: To further evaluate the effectiveness of the same treatment combination in a larger group of patients with the same conditions.

This clinical study is for patients who have a type of uterine cancer that has not been treated with chemotherapy before. Here's what patients need to know to participate:

Cancer Type: The study is open to patients with HER2-positive endometrial serous carcinoma or carcinosarcoma.

Cancer Stage: Patients with any stage from the earliest (stage IA) to the most advanced (stage IVB) can join, provided their cancer has not come back after initial treatment.

Surgery Requirements: Patients must have had surgery for their cancer within the last 8 weeks. If they didn’t have a hysterectomy, a biopsy confirming cancer is required.

Disease Measurement: The study includes patients whether their disease can be measured by scans or not. For those with measurable disease, specific criteria based on scan results are used to define it.

Eligibility Criteria: The study includes patients whether their disease can be measured by scans or not. For those with measurable disease, specific criteria based on scan results are used to define it.

Eligibility Criteria: 

  • Patients must show invasive cancer growth into the muscle layer of the uterus.
  • Cancer should be confirmed as HER2-positive by tests outlined in the 2018 guidelines.
  • Patients need to be healthy enough for chemotherapy (with certain blood count and organ function levels within required ranges).
  • Patients with HIV must have an undetectable viral load.
  • Women of childbearing potential must have a negative pregnancy test.
  • Individuals with other types of cancer or certain medical conditions may still be eligible.

Participants will also need to provide a consent form before joining the study.

For this clinical study, there are certain conditions that would prevent someone from participating:

Prior Cancer Treatment: You cannot join if you've had chemotherapy, biological therapy, or targeted therapy for endometrial cancer before. Also, you shouldn’t have had radiation therapy for endometrial cancer, except for vaginal brachytherapy, which is allowed during the study.

Hormonal Therapy: If you’ve received hormonal therapy for endometrial cancer, you must stop it at least one week before joining the study.

Upcoming Surgeries or Radiation: You cannot plan to have major surgery (like a hysterectomy) or external beam radiation therapy until the cancer shows signs of progression after joining the study.

Heart Conditions: You can't join if you have uncontrolled high blood pressure, recent heart attacks or severe heart disease, or serious heart rhythm problems.

Lung Conditions: If you have severe lung disease, including difficulty breathing at rest, severe pneumonitis, or other serious lung conditions, you cannot participate.

Other Health Issues: Uncontrolled infections, severe congestive heart failure, or any serious mental health or social situations that could affect your ability to follow the study rules are also reasons you might not be able to join.

Medications: If you’ve been treated with certain strong medications that affect liver enzymes within two weeks before joining the study, you may need to wait longer.

Nursing Women: If you are nursing and unwilling to stop, you cannot participate in the study.

This is NOT a complete list of sites. Please refer to the clinical trial webpage for the complete, updated sites.

Alabama Locations
  • Birmingham, AL 35233
    • University of Alabama at Birmingham Cancer Center
    • Contact: Site Public Contact, 205-934-0220, tmyrick@uab.edu
    • Principal Investigator: Michael D. Toboni

Arizona Locations

  • Tucson, AZ 85719
    • Banner University Medical Center - Tucson
    • Contact: Site Public Contact, UACC-IIT@uacc.arizona.edu
    • Principal Investigator: Setsuko K. Chambers
    • University of Arizona Cancer Center-North Campus
    • Contact: Site Public Contact, UACC-IIT@uacc.arizona.edu
    • Principal Investigator: Setsuko K. Chambers

Arkansas Locations

  • Little Rock, AR 72205
    • University of Arkansas for Medical Sciences
    • Contact: Site Public Contact, 501-686-8274
    • Principal Investigator: Heather R. Williams

California Locations

  • Auburn, CA 95602
  • Berkeley, CA 94704
  • Concord, CA 94520
    • John Muir Medical Center-Concord Campus
    • Contact: Site Public Contact, 925-674-2580
    • Principal Investigator: Babak Edraki
  • Duarte, CA 91010
    • City of Hope Comprehensive Cancer Center
    • Contact: Site Public Contact, 800-826-4673, becomingapatient@coh.org
    • Principal Investigator: Joshua G. Cohen
  • Huntington Beach, CA 92648
    • City of Hope at Huntington Beach
    • Contact: Site Public Contact, 877-467-3411
    • Principal Investigator: Joshua G. Cohen

Irvine, CA 92618

  • City of Hope at Irvine Lennar
    • Contact: Site Public Contact, 877-467-3411
    • Principal Investigator: Joshua G. Cohen
  • Kaiser Permanente-Irvine

Long Beach, CA 90813

  • City of Hope at Long Beach Elm
    • Contact: Site Public Contact, 877-467-3411
    • Principal Investigator: Joshua G. Cohen

Los Angeles, CA 90027

  • Kaiser Permanente Los Angeles Medical Center

Modesto, CA 95355

Mountain View, CA 94040

Riverside, CA 92505

  • Kaiser Permanente-Riverside

Roseville, CA 95661

Sacramento, CA 95817

  • University of California Davis Comprehensive Cancer Center
    • Contact: Site Public Contact, 916-734-3089
    • Principal Investigator: Rebecca A. Brooks

San Francisco, CA 94115

Sunnyvale, CA 94086

Upland, CA 91786

  • City of Hope Upland

Walnut Creek, CA 94598

  • John Muir Medical Center-Walnut Creek
    • Contact: Site Public Contact, 925-941-4246
    • Principal Investigator: Babak Edraki

Colorado Locations

  • Aurora, CO 80045
    • UCHealth University of Colorado Hospital
    • Contact: Site Public Contact, 720-848-0650
    • Principal Investigator: Marisa R. Moroney

Denver, CO 80206

  • UCHealth - Cherry Creek
    • Contact: Site Public Contact, 412-339-5294, Roster@nrgoncology.org
    • Principal Investigator: Marisa R. Moroney

Greeley, CO 80631

Highlands Ranch, CO 80129

  • UCHealth Highlands Ranch Hospital
    • Contact: Site Public Contact, 720-848-0650
    • Principal Investigator: Marisa R. Moroney

Loveland, CO 80539

Connecticut Locations

  • Danbury, CT 06810
    • Danbury Hospital
    • Contact: Site Public Contact, 203-739-8074
    • Principal Investigator: Wenli Gao
  • Derby, CT 06418
    • Smilow Cancer Hospital-Derby Care Center
    • Contact: Site Public Contact, 203-785-5702, canceranswers@yale.edu
    • Principal Investigator: Alessandro D. Santin
  • Fairfield, CT 06824
    • Smilow Cancer Hospital Care Center-Fairfield
    • Contact: Site Public Contact, 203-785-5702, canceranswers@yale.edu
    • Principal Investigator: Alessandro D. Santin
  • Glastonbury, CT 06033
    • Smilow Cancer Hospital Care Center at Glastonbury
    • Contact: Site Public Contact, 203-785-5702, canceranswers@yale.edu
    • Principal Investigator: Alessandro D. Santin
  • Greenwich, CT 06830
    • Smilow Cancer Hospital Care Center at Greenwich
    • Contact: Site Public Contact, 203-785-5702, canceranswers@yale.edu
    • Principal Investigator: Alessandro D. Santin
  • Guilford, CT 06437
    • Smilow Cancer Hospital Care Center - Guilford
    • Contact: Site Public Contact, 203-785-5702, canceranswers@yale.edu
    • Principal Investigator: Alessandro D. Santin
  • Hartford, CT 06105
    • Smilow Cancer Hospital Care Center at Saint Francis
    • Contact: Site Public Contact, 203-785-5702, canceranswers@yale.edu
    • Principal Investigator: Alessandro D. Santin
  • New Haven, CT 06520
    • Yale University
    • Contact: Site Public Contact, 203-785-5702, canceranswers@yale.edu
    • Principal Investigator: Alessandro D. Santin
  • North Haven, CT 06473
    • Yale-New Haven Hospital North Haven Medical Center
    • Contact: Site Public Contact, 203-785-5702, canceranswers@yale.edu
    • Principal Investigator: Alessandro D. Santin
  • Norwalk, CT 06856
  • Stamford, CT 06902
    • Smilow Cancer Hospital Care Center at Long Ridge
    • Contact: Site Public Contact, 203-785-5702, canceranswers@yale.edu
    • Principal Investigator: Alessandro D. Santin
  • Torrington, CT 06790
    • Smilow Cancer Hospital-Torrington Care Center
    • Contact: Site Public Contact, 203-785-5702, canceranswers@yale.edu
    • Principal Investigator: Alessandro D. Santin
  • Trumbull, CT 06611
    • Smilow Cancer Hospital Care Center-Trumbull
    • Contact: Site Public Contact, 203-785-5702, canceranswers@yale.edu
    • Principal Investigator: Alessandro D. Santin
  • Waterbury, CT 06708
    • Smilow Cancer Hospital-Waterbury Care Center
    • Contact: Site Public Contact, 203-785-5702, canceranswers@yale.edu
    • Principal Investigator: Alessandro D. Santin
  • Waterford, CT 06385
    • Smilow Cancer Hospital Care Center - Waterford
    • Contact: Site Public Contact, 203-785-5702, canceranswers@yale.edu
    • Principal Investigator: Alessandro D. Santin

Delaware Locations

  • Newark, DE 19713
    • Helen F Graham Cancer Center
    • Contact: Site Public Contact, 302-623-4450, lbarone@christianacare.org
    • Principal Investigator: Gregory A. Masters
    • Medical Oncology Hematology Consultants PA
    • Contact: Same as above
    • Principal Investigator: Same as above

District of Columbia Locations

  • Washington, DC 20016
    • Sibley Memorial Hospital
    • Contact: Site Public Contact, 202-243-2373, jquiver1@jhmi.edu
    • Principal Investigator: Amanda N. Fader
  • Washington, DC 20037
    • George Washington University Medical Center
    • Contact: Site Public Contact, 202-741-2981
    • Principal Investigator: Nicole P. Chappell

Florida Locations

  • Orlando, FL 32803
  • Sarasota, FL 34236
    • Florida Cancer Specialists - Sarasota Downtown
    • Contact: Site Public Contact, 941-957-1000
    • Principal Investigator: Beverly Long
  • Sarasota, FL 34239
    • First Physicians Group-Sarasota
    • Contact: Site Public Contact, 941-917-8383
    • Principal Investigator: Beverly Long
    • Sarasota Memorial Hospital
    • Contact: Site Public Contact, 941-917-2225
    • Principal Investigator: Beverly Long
  • Venice, FL 34292
    • Florida Cancer Specialists - Venice Healthpark
    • Contact: Site Public Contact, 412-339-5294, Roster@nrgoncology.org
    • Principal Investigator: Beverly Long

Georgia Locations

  • Atlanta, GA 30303
    • Grady Health System
    • Contact: Site Public Contact, 404-489-9164
    • Principal Investigator: Namita Khanna
  • Atlanta, GA 30308
    • Emory University Hospital Midtown
    • Contact: Site Public Contact, 888-946-7447
    • Principal Investigator: Namita Khanna
  • Atlanta, GA 30322
    • Emory University Hospital/Winship Cancer Institute
    • Contact: Site Public Contact, 404-778-1868
    • Principal Investigator: Namita Khanna
  • Atlanta, GA 30342
    • Emory Saint Joseph's Hospital
    • Contact: Site Public Contact, 404-851-7115
    • Principal Investigator: Namita Khanna
  • Augusta, GA 30912
    • Augusta University Medical Center
    • Contact: Site Public Contact, 706-721-2388, ga_cares@augusta.edu
    • Principal Investigator: Sharad A. Ghamande
  • Savannah, GA 31405
    • Lewis Cancer and Research Pavilion at Saint Joseph's/Candler
    • Contact: Site Public Contact, 912-819-5704, underberga@sjchs.org
    • Principal Investigator: Sarah E. Gill

Hawaii Locations

  • Honolulu, HI 96813
    • Queen's Medical Center
    • Contact: Site Public Contact, 808-545-8548
    • Principal Investigator: Michael E. Carney
  • Honolulu, HI 96826
    • Kapiolani Medical Center for Women and Children
    • Contact: Site Public Contact, 808-983-6090
    • Principal Investigator: Michael E. Carney

Idaho Locations

  • Boise, ID 83706
    • Saint Alphonsus Cancer Care Center-Boise
    • Contact: Site Public Contact, 734-712-3671, stephanie.couch@stjoeshealth.org
    • Principal Investigator: John M. Schallenkamp
  • Boise, ID 83712
    • Saint Luke's Cancer Institute - Boise
    • Contact: Site Public Contact, 208-381-2774, eslinget@slhs.org
    • Principal Investigator: Nitya Alluri
  • Caldwell, ID 83605
    • Saint Alphonsus Cancer Care Center-Caldwell
    • Contact: Site Public Contact, 734-712-3671, stephanie.couch@stjoeshealth.org
    • Principal Investigator: John M. Schallenkamp
  • Coeur d'Alene, ID 83814
    • Kootenai Health - Coeur d'Alene
    • Contact: Site Public Contact, 406-969-6060, mccinfo@mtcancer.org
    • Principal Investigator: John M. Schallenkamp

Fruitland, ID 83619

  • Saint Luke's Cancer Institute - Fruitland
  • Contact: Site Public Contact, 208-381-2774, eslinget@slhs.org
  • Principal Investigator: Nitya Alluri

Meridian, ID 83642

  • Saint Luke's Cancer Institute - Meridian
  • Contact: Site Public Contact, 208-381-2774, eslinget@slhs.org
  • Principal Investigator: Nitya Alluri

Nampa, ID 83686

  • Saint Luke's Cancer Institute - Nampa
  • Contact: Site Public Contact, 208-381-2774, eslinget@slhs.org
  • Principal Investigator: Nitya Alluri

Nampa, ID 83687

  • Saint Alphonsus Cancer Care Center-Nampa
  • Contact: Site Public Contact, 406-969-6060, mccinfo@mtcancer.org
  • Principal Investigator: John M. Schallenkamp

Post Falls, ID 83854

  • Kootenai Clinic Cancer Services - Post Falls
  • Contact: Site Public Contact, 406-969-6060, mccinfo@mtcancer.org
  • Principal Investigator: John M. Schallenkamp

Sandpoint, ID 83864

  • Kootenai Cancer Clinic
  • Contact: Site Public Contact, 406-969-6060,mccinfo@mtcancer.org
  • Principal Investigator: John M. Schallenkamp

Twin Falls, ID 83301

  • Saint Luke's Cancer Institute - Twin Falls
  • Contact: Site Public Contact, 208-381-2774, eslinget@slhs.org
  • Principal Investigator: Nitya Alluri

Illinois Locations

  • Arlington Heights, IL 60005
    • Northwest Community Hospital
    • Contact: Site Public Contact, 847-618-4968
    • Principal Investigator: Kathryn A. Mills
  • Aurora, IL 60504
  • Centralia, IL 62801
    • Centralia Oncology Clinic
    • Contact: Site Public Contact, 217-876-4762, morganthaler.jodi@mhsil.com
    • Principal Investigator: Bryan A. Faller
  • Chicago, IL 60611
    • Northwestern University
    • Contact: Site Public Contact, 312-695-1301, cancer@northwestern.edu
    • Principal Investigator: Emily Hinchcliff

Chicago, IL 60612

  • John H Stroger Jr Hospital of Cook County
  • Contact: Site Public Contact, 312-864-5204
  • Principal Investigator: Thomas E. Lad
  • Rush University Medical Center
  • Contact: Site Public Contact, 312-942-5498, clinical_trials@rush.edu
  • Principal Investigator: Summer B. Dewdney

Chicago, IL 60637

Danville, IL 61832

  • Carle at The Riverfront
  • Contact: Site Public Contact, 800-446-5532, Research@Carle.com
  • Principal Investigator: Pratima Chalasani

Decatur, IL 62526

  • Cancer Care Specialists of Illinois - Decatur
  • Contact: Site Public Contact, 217-876-4762, morganthaler.jodi@mhsil.com
  • Principal Investigator: Bryan A. Faller
  • Decatur Memorial Hospital
  • Contact: Site Public Contact, 217-876-4762, morganthaler.jodi@mhsil.com
  • Principal Investigator: Bryan A. Faller

DeKalb, IL 60115

  • Northwestern Medicine Cancer Center Kishwaukee
  • Contact: Site Public Contact, 630-352-5360, Donald.Smith3@nm.org
  • Principal Investigator: Emily Hinchcliff

Effingham, IL 62401

  • Carle Physician Group-Effingham
  • Contact: Site Public Contact, 800-446-5532, Research@carle.com
  • Principal Investigator: Pratima Chalasani
  • Crossroads Cancer Center
  • Contact: Site Public Contact, 217-876-4762, morganthaler.jodi@mhsil.com
  • Principal Investigator: Bryan A. Faller

Evanston, IL 60201

  • NorthShore University HealthSystem-Evanston Hospital
  • Contact: Site Public Contact, 847-570-2109
  • Principal Investigator: Mary T. Jenkins Vogel

Geneva, IL 60134

  • Northwestern Medicine Cancer Center Delnor
  • Contact: Site Public Contact, 630-352-5360, Donald.Smith3@nm.org
  • Principal Investigator: Emily Hinchcliff

Glenview, IL 60026

  • NorthShore University HealthSystem-Glenbrook Hospital
  • Contact: Site Public Contact, 847-570-2109
  • Principal Investigator: Mary T. Jenkins Vogel

Highland Park, IL 60035

  • NorthShore University HealthSystem-Highland Park Hospital
  • Contact: Site Public Contact, 847-570-2109
  • Principal Investigator: Mary T. Jenkins Vogel

Hinsdale, IL 60521

  • Sudarshan K Sharma MD Limited-Gynecologic Oncology
  • Contact: Site Public Contact, 630-856-6757
  • Principal Investigator: Sudarshan K. Sharma

Lake Forest, IL 60045

Mattoon, IL 61938

  • Carle Physician Group-Mattoon/Charleston
  • Contact: Site Public Contact, 800-446-5532, Research@carle.com
  • Principal Investigator: Pratima Chalasani

New Lenox, IL 60451

O'Fallon, IL 62269

  • Cancer Care Center of O'Fallon
  • Contact: Site Public Contact, 217-876-4762, morganthaler.jodi@mhsil.com
  • Principal Investigator: Bryan A. Faller

Orland Park, IL 60462

Springfield, IL 62702

  • Southern Illinois University School of Medicine
  • Contact: Site Public Contact, 217-545-7929
  • Principal Investigator: Bryan A. Faller
  • Springfield Clinic
  • Contact: Site Public Contact, 800-444-7541
  • Principal Investigator: Bryan A. Faller
  • Memorial Medical Center
  • Contact: Site Public Contact, 217-528-7541, pallante.beth@mhsil.com
  • Principal Investigator: Bryan A. Faller

Urbana, IL 61801

  • Carle Cancer Center
  • Contact: Site Public Contact, 800-446-5532, Research@carle.com
  • Principal Investigator: Pratima Chalasani

Warrenville, IL 60555

  • Northwestern Medicine Cancer Center Warrenville
  • Contact: Site Public Contact, 630-352-5360, Donald.Smith3@nm.org
  • Principal Investigator: Emily Hinchcliff

Yorkville, IL 60560

Indiana Locations

Crown Point, IN 46307

  • Northwest Cancer Center - Main Campus
  • Contact: Site Public Contact, 219-310-2550
  • Principal Investigator: Pratima Chalasani

Dyer, IN 46311

  • Northwest Oncology LLC
  • Contact: Site Public Contact, 219-924-8178
  • Principal Investigator: Pratima Chalasani

Goshen, IN 46526

  • Goshen Center for Cancer Care
  • Contact: Site Public Contact, 574-364-2973, cccois@goshenhealth.com
  • Principal Investigator: Pamela J. Stone

Hobart, IN 46342

  • Northwest Cancer Center - Hobart
  • Contact: Site Public Contact, 219-947-1795
  • Principal Investigator: Pratima Chalasani
    • Saint Mary Medical Center
    • Contact: Site Public Contact, 219-836-6875, CancerResearch@COMHS.org
    • Principal Investigator: Pratima Chalasani

Indianapolis, IN 46202

  • Indiana University/Melvin and Bren Simon Cancer Center
  • Contact: Site Public Contact, 317-278-5632, iutrials@iu.edu
  • Principal Investigator: Jessica E. Parker

Indianapolis, IN 46237

  • Franciscan Health Indianapolis
  • Contact: Site Public Contact, 317-528-7060
  • Principal Investigator: Harsha Ranganath

Indianapolis, IN 46260

  • Ascension Saint Vincent Indianapolis Hospital
  • Contact: Site Public Contact, 317-338-2194, research@stvincent.org
  • Principal Investigator: Megan E. Buechel

Indianapolis, IN 46312

  • Saint Catherine Hospital
  • Contact: Site Public Contact, 412-339-5294, Roster@nrgoncology.org
  • Principal Investigator: Pratima Chalasani

Lafayette, IN 47905

  • Franciscan Saint Elizabeth Health - Lafayette East
  • Contact: Site Public Contact, 888-823-5923, ctsucontact@westat.com
  • Principal Investigator: Harsha Ranganath

Mooresville, IN 46158

  • Franciscan Health Mooresville
  • Contact: Site Public Contact, 317-834-3603
  • Principal Investigator: Harsha Ranganath

Munster, IN 46321

  • The Community Hospital
  • Contact: Site Public Contact, 219-836-3349
  • Principal Investigator: Pratima Chalasani
    • Women's Diagnostic Center - Munster
    • Contact: Site Public Contact, 219-934-8869, mnicholson@comhs.org
    • Principal Investigator: Pratima Chalasani

South Bend, IN 46601

  • Memorial Hospital of South Bend
  • Contact: Site Public Contact, 800-284-7370
  • Principal Investigator: Nonyem A. Onujiogu

Valparaiso, IN 46383

  • Northwest Cancer Center - Valparaiso
  • Contact: Site Public Contact, 219-836-6875, CancerResearch@COMHS.org
  • Principal Investigator: Pratima Chalasani

‍

Any other information

Link to clinicaltrails.gov

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*The information provided here is not intended to be medical advice. Please use your discretion and your health care team’s advice for your healthcare decisions.

At Together4Cancer, our mission is to empower patients and caregivers with clear, accessible information and practical guidance for navigating the cancer journey.

Drawing from my 15 years of experience as an oncology pharmacist and caregiver, I understand firsthand the overwhelming challenges cancer brings, even with resources and knowledge.

This platform is designed to share vital knowledge, provide crucial resources, and promote self-advocacy, ensuring people ask the right questions and make informed healthcare decisions. We’re here to make the path through cancer easier, one step at a time.

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