A Phase II Study of Trastuzumab/Vinorelbine versus Trastuzumab/Vinorelbine with Immunotherapy in Patients with HER2-Positive Metastatic Breast Cancer

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Full Title

A Randomized, Phase II Study Comparing Trastuzumab and Vinorelbine in Combination with Avelumab or Avelumab and Utomilumab (41BB/CD137 agonist), in Patients with HER2-positive Metastatic Breast Cancer Who Have Progressed on Prior Trastuzumab and Pertuzumab (the AVIATOR study)

Purpose

Drugs that target the HER2 protein, such as trastuzumab, are used to treat breast cancer that produces high levels of this protein. But sometimes the cancer continues to grow. In this study, researchers are comparing the effectiveness of three drug combinations in patients with metastatic HER2-positive breast cancer that continues to grow despite trastuzumab or pertuzumab therapy. Two of the treatment combinations include immunotherapy drugs, which boost the power of the immune system to find and kill cancer cells or stimulate immune cells to fight cancer cells.

Patients will be randomly assigned to one of three treatments:

  • Trastuzumab and vinorelbine
  • Trastuzumab and vinorelbine plus avelumab immunotherapy
  • Trastuzumab and vinorelbine plus avelumab and utomilumab immunotherapy

These medications are given intravenously (by vein).

Eligibility

To be eligible for this study, patients must meet several criteria, including but not limited to the following:

  • Patients must have metastatic HER2-positive breast cancer that continues to grow despite therapy with trastuzumab, pertuzumab, and ado-trastuzumab emtansine.
  • At least 3 weeks must pass between the completion of prior treatments and entry into the study.
  • Prior treatment with vinorelbine or immunotherapy is not permitted.
  • Patients must be physically well enough that they are fully ambulatory, capable of all self care, and are capable of all but physically strenuous activities. As an example, patients must be well enough that they would be able to carry out office work or light housework.
  • This study is for patients age 18 and older.

For more information about this study and to inquire about eligibility, please contact Dr. Chau Dang at 914-367-7181.

Protocol

19-063

Phase

II

Disease Status

Relapsed or Refractory

Investigator

Co-Investigators

Diseases