Herceptin Hylecta or Phesgo Added to Chemo for Endometrial Cancer

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

Recruiting Phase 3 Interventional Study
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
No Placebo Group Every participant receives an active treatment — no one gets a placebo. Pivotal Trial This treatment is in the last trial phase before FDA approval. Prior Safety Data This treatment has already been tested in at least one earlier human trial.
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Review the details below, then apply to join this clinical trial.

At a Glance
Age
18 and older
Sex
Female
Trial phase
Phase 3
Study type
Interventional
Purpose
Treatment
Participants needed
360 (estimated)
Sponsor
National Cancer Institute (NCI) · NIH
Who this trial is looking for

This trial is looking for patients with HER2 positive endometrial cancer who have not had any previous chemotherapy. Participants will receive standard chemotherapy along with Herceptin Hylecta or Phesgo to see if it helps shrink tumors.

Are You a Good Fit for This Trial?

You may be able to join if

  • I have been diagnosed with HER2 positive endometrial cancer.
  • I have not received any prior chemotherapy for this cancer.
  • I am within 8 weeks of my primary surgery.
  • I am at least 18 years old.
  • I have measurable disease or no measurable disease.
  • I have a performance status of 0, 1, or 2.
  • I have a certain level of platelets and neutrophils.
  • I can provide consent to participate in the trial.

You may not be able to join if

  • I have received prior chemotherapy for endometrial cancer.
  • I have received prior radiation therapy for endometrial cancer.
  • I have a form of endometrial cancer that is mismatch repair deficient.
  • I have had a hysterectomy or bilateral oophorectomy less than 6 weeks ago.
  • I have active hepatitis B or have not been cured of hepatitis C.
  • I have untreated brain metastases.
  • I have a serious medical condition that affects my safety.
  • I cannot provide consent to participate in the trial.

Summarized in plain language from this trial's official eligibility criteria. The full criteria are further down this page — only the research team can confirm whether you qualify.

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About This Trial
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 spe…
Trial Locations
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Eligibility Criteria
Inclusion Criteria: * Federation of Gynecology and Obstetrics (FIGO) 2009 stage IA-IVB, non-recurrent, chemotherapy (chemo)-naive, HER2-positive endometrial cancer. The following endometrial cancer types are eligible: * Serous * Other endometrial cancers (including clear cell, endometrioid, mi…
Contacts

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