Testing the Addition of Trastuzumab or Trastuzumab/Pertuzumab to Usual Chemotherapy for HER2 Positive Endometrial Serous Carcinoma or Carcinosarcoma

Sponsor: National Cancer Institute (NCI)

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT05256225

Provider View

This clinical trial is exploring whether adding trastuzumab or a combination of trastuzumab and pertuzumab to standard chemotherapy can help shrink tumors in patients with HER2 positive endometrial serous carcinoma or carcinosarcoma.

Patient Parameters

Program Overview

This study is testing if adding trastuzumab (Herceptin Hylecta) or a combination of trastuzumab and pertuzumab (Phesgo) to the usual chemotherapy drugs, paclitaxel and carboplatin, can help shrink tumors in patients with HER2 positive endometrial serous carcinoma or carcinosarcoma. Trastuzumab and pertuzumab are targeted therapies that attach to HER2 receptors on cancer cells, blocking signals that make the cells grow and marking them for destruction by the immune system. Hyaluronidase helps these drugs stay in the body longer and allows them to be given by injection under the skin, making treatment quicker. Paclitaxel and carboplatin are chemotherapy drugs that stop cancer cells from growing and dividing. This combination may help shrink tumors and prevent cancer from returning.

Description

The main goal of this study is to see if adding trastuzumab or a combination of trastuzumab and pertuzumab to the usual chemotherapy can effectively treat HER2 positive endometrial serous carcinoma or carcinosarcoma. The study will also look at how long the treatment works, any side effects, and how it affects patients' quality of life.

Patients will be randomly assigned to one of three groups:

  • Group 1: Receives paclitaxel and carboplatin every three weeks for six cycles. If the cancer is stable or partially responds, patients may receive up to four more cycles.
  • Group 2: Receives paclitaxel, carboplatin, and trastuzumab/hyaluronidase every three weeks for six cycles. If the cancer is stable or partially responds, patients may receive up to four more cycles. Afterward, they may continue with trastuzumab/hyaluronidase every three weeks for up to three years.
  • Group 3: Receives paclitaxel, carboplatin, and pertuzumab/trastuzumab/hyaluronidase every three weeks for six cycles. If the cancer is stable or partially responds, patients may receive up to four more cycles. Afterward, they may continue with pertuzumab/trastuzumab/hyaluronidase every three weeks for up to three years.

Throughout the study, patients will have heart and CT scans and may provide blood and urine samples. After treatment, patients will have follow-up visits every three months for two years, then every six months for three years.

Eligibility Criteria

Inclusion Criteria

  • Diagnosed with HER2 positive endometrial serous carcinoma or carcinosarcoma, stage IA-IVB, and have not received chemotherapy before.
  • Must have had surgery or a biopsy within the last eight weeks.
  • Can have measurable or non-measurable disease.
  • Tumors must be HER2 positive based on specific medical tests.
  • Must be 18 years or older.
  • Must have good blood counts and organ function.
  • HIV-positive patients can participate if their viral load is undetectable.
  • Women of childbearing potential must have a negative pregnancy test and agree to use contraception.
  • Patients with other cancers can participate if it doesn't interfere with this study.
  • Patients with treated brain metastases can participate if there's no progression.
  • Must provide informed consent.

Exclusion Criteria

  • Cannot have had prior chemotherapy, biologic, or targeted therapy for endometrial cancer.
  • Cannot have had prior radiation therapy for endometrial cancer, except for vaginal brachytherapy during the study.
  • Cannot have planned surgery or radiation before cancer progression.
  • Cannot have significant heart or lung disease.
  • Cannot have uncontrolled illnesses or infections.
  • Cannot be taking certain medications that affect the study drugs.
  • Women must not be breastfeeding.

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