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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

Must not have

Treatment with strong CYP2C8 or CYP3A4 inhibitors or inducers within 14 days or 5 drug-elimination half-lives, whichever is longer, prior to registration

Patients must NOT have received prior radiation therapy for treatment of endometrial carcinoma

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline up to 5 years

Awards & highlights

No Placebo-Only Group

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.

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.

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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I haven't taken strong medication that affects drug metabolism in the last 14 days or longer.

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I have not had radiation therapy for endometrial cancer.

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I have severe lung problems that make it hard to breathe even when resting.

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I have not had chemotherapy, biologic, or targeted therapy for endometrial cancer.

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I do not have any severe illnesses or social situations that would stop me from following the study's requirements.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline up to 5 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Incidence of dose limiting toxicities (Phase II)

Overall survival (Phase III)

Progression free survival (Phase II)

Secondary study objectives

Duration of objective response

HER2 expression

Incidence of adverse events (AEs)

+2 more

Other study objectives

QoL deterioration

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

3Treatment groups

Experimental Treatment

Active Control

Group I: Arm III (paclitaxel, carboplatin, Phesgo)Experimental Treatment9 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 and CT throughout the study. Additionally, patients may optionally undergo blood sample collection throughout the study, vaginal brachytherapy on study, and urine sample collection prior to treatment.

Group II: Arm II (paclitaxel, carboplatin, Herceptin Hylecta)Experimental Treatment9 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 and CT throughout the study. Additionally patients may optionally undergo blood sample collection throughout the study, vaginal brachytherapy on study, and urine sample collection prior to treatment.

Group III: Arm I (paclitaxel, carboplatin)Active Control8 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 and CT throughout the study. Additionally, patients may optionally undergo blood sample collection throughout the study, vaginal brachytherapy on study, and urine sample collection prior to treatment.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Computed Tomography

2017

Completed Phase 2

~2790

Biospecimen Collection

2004

Completed Phase 3

~2030