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

StatusActive, Not Recruiting
PhasePhase 3
Started
View on ClinicalTrials.gov ↗

Record History

The 50 most recent of 523 record versions are listed below. See every version on ClinicalTrials.gov ↗

  1. Re-verified, no change to tracked fields
  2. Enrollment closed, study ongoing Study sites revised (414) Show 1 more changeShow less
    • Study sites revised (414)
  3. Site contacts updated at 1 of 414 sites
  4. Site details revised at 1 of 414 sites
  5. Interventions: Biospecimen Collection (Procedure), Carboplatin (Drug), Computed Tomography (Procedure), Echocardiography Test (Procedure), High-Dose-Rate… to Biospecimen Collection (Procedure), Carboplatin (Drug), Computed Tomography (Procedure), Echocardiography Test (Procedure), High-Dose-Rate… Secondary endpoints: details revised at 3 of 5 entries · Site details revised at 51 of 414 sites Show 2 more changesShow less
    • Secondary endpoints: details revised at 3 of 5 entries
    • Site details revised at 51 of 414 sites
Show 26 earlier versionsHide 26 earlier versions
  1. Site details revised at 1 of 414 sitesv518
  2. Site details revised at 1 of 414 sitesv517
  3. Site details revised at 1 of 414 sitesv516
  4. Site details revised at 1 of 414 sitesv515
  5. Site details revised at 5 of 414 sitesv514
  6. Site details revised at 5 of 414 sitesv513
  7. Site details revised at 3 of 414 sitesv512
  8. Site details revised at 1 of 414 sitesv511
  9. Site details revised at 2 of 414 sitesv510
  10. Site details revised at 10 of 414 sitesv509
  11. Study sites: 413 to 414v508
  12. Site details revised at 3 of 413 sitesv507
  13. Study sites: 411 to 413v506
  14. Study sites: 409 to 411v505
  15. Site details revised at 4 of 409 sitesv504
  16. Site details revised at 2 of 409 sitesv503
  17. Site details revised at 1 of 409 sitesv502
  18. Site details revised at 1 of 409 sitesv501
  19. Site details revised at 2 of 409 sitesv500
  20. Study sites revised (409)v499 See this version in full on ClinicalTrials.gov ↗
  21. Site details revised at 2 of 409 sitesv498
  22. Site details revised at 19 of 409 sitesv497
  23. Study sites revised (409)v496 See this version in full on ClinicalTrials.gov ↗
  24. Site details revised at 4 of 409 sitesv495
  25. Site details revised at 1 of 409 sitesv494
  26. Trial status: Suspended to Recruiting Study sites: 408 to 409v493 Show 1 more changeShow less
    • Study sites: 408 to 409
  1. Recruitment suspended Sponsor's reason: Other - Revisions to ICF Site details revised at 408 of 408 sitesv492 Show 1 more changeShow less
    • Site details revised at 408 of 408 sites
  2. Site details revised at 1 of 408 sitesv491
  3. Site details revised at 1 of 408 sitesv490
  4. Site details revised at 2 of 408 sitesv489
  5. Site details revised at 1 of 408 sitesv488
  6. Site details revised at 2 of 408 sitesv487
  7. Site details revised at 1 of 408 sitesv486
  8. Site details revised at 2 of 408 sitesv485
  9. Site details revised at 1 of 408 sitesv484
  10. Site details revised at 6 of 408 sitesv483
  11. Site details revised at 7 of 408 sitesv482
  12. Site details revised at 5 of 408 sitesv481
  13. Site details revised at 8 of 408 sitesv480
  14. Site details revised at 1 of 408 sitesv479
  15. Site details revised at 8 of 408 sitesv478
  16. Site details revised at 4 of 408 sitesv477
  17. Study sites: 409 to 408v476
  18. Site details revised at 1 of 409 sitesv475
  19. Site details revised at 1 of 409 sitesv474
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT05256225
Lead Sponsor National Cancer Institute (NCI)
Collaborators: NRG Oncology
Conditions Endometrial Carcinoma, Endometrial Clear Cell Adenocarcinoma, Endometrial Dedifferentiated Carcinoma, Endometrial Endometrioid Adenocarcinoma, Endometrial Mixed Cell Adenocarcinoma, Endometrial Serous Adenocarcinoma, Endometrial Undifferentiated Carcinoma, Uterine Corpus Malignant Mixed Mesodermal (Mullerian) Tumor
Enrollment 360 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov