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NCT05256225 · ClinicalTrials.gov registry record · Phase 3
Testing the Addition of Herceptin Hylecta or Phesgo to the Usual Chemotherapy for HER2 Positive Endometrial Serous Carcinoma or Carcinosarcoma
A Phase 3 study of Endometrial Carcinoma and Endometrial Serous Adenocarcinoma, sponsored by National Cancer Institute (NCI).
- Recruiting
- Registry status
- Phase 3
- Development phase
- 360
- Enrollment target
- 20
- Study locations
NCT05256225: Recruiting Phase 3 study of Endometrial Carcinoma and Endometrial Serous Adenocarcinoma, sponsored by National Cancer Institute (NCI).
NCT05256225 is a Phase 3 study of Endometrial Carcinoma and Endometrial Serous Adenocarcinoma that is actively recruiting participants, run by National Cancer Institute (NCI). The registered enrollment target is 360 participants, roughly in line with the 377-participant average among 27 other Endometrial Carcinoma trials with a reported enrollment target. The trial reports 20 study locations across 5 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05256225, a Phase 3 study of Endometrial Carcinoma and Endometrial Serous Adenocarcinoma, is actively recruiting participants, sponsored by National Cancer Institute (NCI).
- RECRUITING
- Registry status
- Phase 3
- Development phase
- 360 participants
- Enrollment target
- 20
- Study locations
Study Summary
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.
Primary Outcome
At the end of Phase 2 analysis, if both experimental arms demonstrate superiority to the reference, the experimental arms will be compared to each other.
Conditions Studied
Interventions
- DRUG Carboplatin
- PROCEDURE Biospecimen Collection
- PROCEDURE Computed Tomography
- PROCEDURE Echocardiography Test
- RADIATION High-Dose-Rate Vaginal Cuff Brachytherapy
Study Locations (20)
California
- Sutter Auburn Faith Hospital - Auburn
- Alta Bates Summit Medical Center-Herrick Campus - Berkeley
- John Muir Medical Center-Concord - Concord
- City of Hope Comprehensive Cancer Center - Duarte
- City of Hope Seacliff - Huntington Beach
- UCI Health - Chao Family Comprehensive Cancer Center and Ambulatory Care - Irvine
- City of Hope at Irvine Lennar - Irvine
- Kaiser Permanente-Irvine - Irvine
- City of Hope at Long Beach Elm - Long Beach
- Kaiser Permanente Los Angeles Medical Center - Los Angeles
- Memorial Medical Center - Modesto
- Palo Alto Medical Foundation-Gynecologic Oncology - Mountain View
- Saint Joseph Hospital - Orange - Orange
- UC Irvine Health/Chao Family Comprehensive Cancer Center - Orange
- Stanford Cancer Institute Palo Alto - Palo Alto
Arizona
- Banner University Medical Center - Tucson - Tucson
- University of Arizona Cancer Center-North Campus - Tucson
Alabama
- University of Alabama at Birmingham Cancer Center - Birmingham
Alaska
- Alaska Women's Cancer Care - Anchorage
Arkansas
- University of Arkansas for Medical Sciences - Little Rock
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 360 participants |
| Start Date | 2022-11-16 |
| Est. Completion | 2027-10-31 |
| Phase | Phase 3 |
What NCT05256225 shows while recruiting
NCT05256225 is an interventional study that assigns participants to a tested intervention. The registered 360 participants enrollment target is mid-sized for trials with a published cap, roughly in line with the 377-participant average among 27 other Endometrial Carcinoma trials with a reported enrollment target.
The record links to 8 conditions, with Endometrial Carcinoma appearing as the primary indexed condition, and to 5 interventions - of which Carboplatin is the first listed.
NCT05256225 names 20 study sites across 5 states, led by California, Arizona, Alabama.
Frequently Asked Questions
What is clinical trial NCT05256225 about?
NCT05256225 is a clinical study titled "Testing the Addition of Herceptin Hylecta or Phesgo to the Usual Chemotherapy for HER2 Positive Endometrial Serous Carcinoma or Carcinosarcoma". 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. T...
What is the current status of trial NCT05256225?
This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 360 participants. The study started on 2022-11-16. Estimated completion is 2027-10-31.
What conditions does trial NCT05256225 study?
This clinical trial studies the following conditions: Endometrial Carcinoma, Endometrial Serous Adenocarcinoma, Endometrial Clear Cell Adenocarcinoma, Endometrial Endometrioid Adenocarcinoma, Endometrial Mixed Cell Adenocarcinoma.
What interventions are being tested in trial NCT05256225?
The interventions under investigation include: Carboplatin (DRUG), Biospecimen Collection (PROCEDURE), Computed Tomography (PROCEDURE), Echocardiography Test (PROCEDURE), High-Dose-Rate Vaginal Cuff Brachytherapy (RADIATION).
Who is sponsoring clinical trial NCT05256225?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05256225 being conducted?
This trial has 20 study locations across Alabama, Alaska, Arizona, Arkansas, California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT05256225's enrollment target sits among peer trials
360 3rd of 27 higher than 25 of 27 other Endometrial Carcinoma trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Endometrial Carcinoma trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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