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Chemotherapy

Herceptin Hylecta or Phesgo + Chemotherapy for Uterine Cancer

Phase 2 & 3
Recruiting
Led By Britt K Erickson
Research Sponsored by National Cancer Institute (NCI)
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
All patients must have tumors that are HER2 positive as defined by American Society of Clinical Oncology (ASCO)/College of American Pathologists (CAP) 2018 Breast Cancer guidelines
Age >= 18
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years from randomization
Awards & highlights

Study Summary

This trial is testing whether adding Herceptin Hylecta or Phesgo to usual chemotherapy (paclitaxel and carboplatin) works to shrink tumors in patients with HER2 positive endometrial serous carcinoma or carcinosarcoma.

Who is the study for?
This trial is for adults with HER2 positive endometrial serous carcinoma or carcinosarcoma who've had surgery within the last 8 weeks. They should not have received prior treatments for their cancer and must be in good health with proper organ function. Women of childbearing potential must test negative for pregnancy, and those with HIV or hepatitis B/C need controlled viral loads.Check my eligibility
What is being tested?
The study tests adding Herceptin Hylecta (trastuzumab/hyaluronidase-oysk) or Phesgo (pertuzumab/trastuzumab/hyaluronidase-zzxf) to standard chemotherapy (paclitaxel/carboplatin). These drugs target specific receptors on tumor cells to block growth signals and mark them for immune destruction, potentially shrinking tumors more effectively.See study design
What are the potential side effects?
Possible side effects include allergic reactions to monoclonal antibodies, heart problems due to trastuzumab/pertuzumab, tissue damage at injection sites from hyaluronidase, nerve damage from paclitaxel, and kidney/liver issues from carboplatin. Side effects can vary widely among patients.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My tumor is HER2 positive according to the latest guidelines.
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I am 18 years old or older.
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I can take care of myself and am up and about more than half of my waking hours.
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My kidney function, measured by creatinine or eGFR, is within the normal range.
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My cancer is either serous adenocarcinoma or carcinosarcoma with a serous part.
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My cancer's diagnosis was confirmed through a biopsy or surgery report.
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I have chronic hepatitis B but it's under control with treatment.
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I have early to advanced stage, HER2-positive endometrial cancer and haven't received chemotherapy.
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I had hepatitis C but have been treated and cured.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years from randomization
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years from randomization for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Incidence of dose limiting toxicities (Phase II)
Overall survival (Phase III)
Progression free survival (Phase II)
Secondary outcome measures
Duration of objective response
HER2 expression
Incidence of adverse events (AEs)
+2 more

Trial Design

3Treatment groups
Experimental Treatment
Active Control
Group I: Arm III (paclitaxel, carboplatin, Phesgo)Experimental Treatment6 Interventions
Patients receive paclitaxel IV over 3 hours, carboplatin IV over 30-60 minutes, and pertuzumab/trastuzumab/hyaluronidase-zzxf SC over 5-8 minutes on day 1 of each cycle. Treatment repeats every 3 weeks for 6 cycles in the absence of disease progression or unacceptable toxicity. Patients with SD or PR who still have measurable disease after completion of cycle 6 may receive 4 additional cycles of this treatment at the discretion of the treating physician. MAINTENANCE: Patients receive pertuzumab/trastuzumab/ hyaluronidase-zzxf SC over 5 minutes on day 1. Cycles repeat every 3 weeks for up to 1 year in absence of disease progression or unacceptable toxicity. Patients with SD or PR may continue maintenance for up to 3 years from the start of treatment. Patients undergo ECHO or MUGA scan at end of treatment and every 6 months for 2 years.
Group II: Arm II (paclitaxel, carboplatin, Herceptin Hylecta)Experimental Treatment6 Interventions
Patients receive paclitaxel IV over 3 hours, carboplatin IV over 30-60 minutes, and trastuzumab/hyaluronidase-oysk SC over 2-5 minutes on day 1 of each cycle. Treatment repeats every 3 weeks for 6 cycles in the absence of disease progression or unacceptable toxicity. Patients with SD or PR who still have measurable disease after completion of cycle 6 may receive 4 additional cycles of this treatment at the discretion of the treating physician. MAINTENANCE: Patients receive trastuzumab/hyaluronidase-oysk SC over 2-5 minutes on day 1 of each cycle. Cycles repeat every 3 weeks for up to 1 year in the absence of disease progression or unacceptable toxicity. Patients with SD or PR may continue maintenance therapy for up to 3 years from the start of treatment. Patients undergo ECHO or MUGA scan at end of treatment and every 6 months for 2 years.
Group III: Arm I (paclitaxel, carboplatin)Active Control5 Interventions
Patients receive paclitaxel IV over 3 hours and carboplatin IV over 30-60 minutes on day 1 of each cycle. Treatment repeats every 3 weeks for 6 cycles in the absence of disease progression or unacceptable toxicity. Patients with SD or PR who still have measurable disease after completion of cycle 6 may receive 4 additional cycles of this treatment at the discretion of the treating physician. Patients undergo ECHO or MUGA scan at end of treatment and every 6 months for 2 years.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Carboplatin
2014
Completed Phase 3
~6670
Echocardiography
2013
Completed Phase 4
~11670
Paclitaxel
2011
Completed Phase 4
~5380

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)Lead Sponsor
13,666 Previous Clinical Trials
40,925,504 Total Patients Enrolled
18 Trials studying Endometrial Carcinoma
8,838 Patients Enrolled for Endometrial Carcinoma
NRG OncologyOTHER
231 Previous Clinical Trials
100,327 Total Patients Enrolled
3 Trials studying Endometrial Carcinoma
223 Patients Enrolled for Endometrial Carcinoma
Britt K EricksonPrincipal InvestigatorNRG Oncology
1 Previous Clinical Trials
46 Total Patients Enrolled

Media Library

Carboplatin (Chemotherapy) Clinical Trial Eligibility Overview. Trial Name: NCT05256225 — Phase 2 & 3
Endometrial Carcinoma Research Study Groups: Arm II (paclitaxel, carboplatin, Herceptin Hylecta), Arm III (paclitaxel, carboplatin, Phesgo), Arm I (paclitaxel, carboplatin)
Endometrial Carcinoma Clinical Trial 2023: Carboplatin Highlights & Side Effects. Trial Name: NCT05256225 — Phase 2 & 3
Carboplatin (Chemotherapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05256225 — Phase 2 & 3
Endometrial Carcinoma Patient Testimony for trial: Trial Name: NCT05256225 — Phase 2 & 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What was the team’s intent when designing this research?

"The primary objective of this clinical trial is to assess overall survival rates. The trial will be monitored over the course of 12 weeks, and secondary objectives include quality of life, incidence of adverse events, and objective response rate."

Answered by AI

Would it be easy to find a location to participate in this clinical trial near me?

"There are a total of 80 medical facilities that are participating in this research project. A few noteworthy locations include Springfield Clinic in Springfield, Springfield Regional Cancer Center in Westerville, and Saint Ann's Hospital in Portland."

Answered by AI

What is the projected or ideal number of people who will participate in this research?

"In order to carry out this study, we need 525 individuals that meet the pre-determined inclusion criteria. These individuals can come from multiple locations, including Springfield Clinic in Springfield, Illinois and Springfield Regional Cancer Center in Westerville, Ohio."

Answered by AI

Who else is applying?

What state do they live in?
Michigan
What site did they apply to?
Bronson Methodist Hospital
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
0

Why did patients apply to this trial?

would like to see if someone can find answers for women like me.
PatientReceived 2+ prior treatments
Recent research and studies
clinicaltrials.govStudy
Testing the Addition of Trastuzumab or Trastuzumab/Pertuzumab to the Usual Chemotherapy for HER2 Positive Endometrial Serous Carcinoma or Carcinosarcoma
2022. "Testing the Addition of Trastuzumab or Trastuzumab/Pertuzumab to the Usual Chemotherapy for HER2 Positive Endometrial Serous Carcinoma or Carcinosarcoma". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05256225.
~350 spots leftby Oct 2027
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