Drug Treatment Study for First-Line HER2-Positive Metastatic Breast Cancer

Clinical Trial Title

A randomized, double-blind, phase III trial of paclitaxel/trastuzumab/pertuzumab with atezolizumab or placebo in first-line HER2-positive metastatic breast cancer.

National Clinical Trial Number:

NCT03199885

Clinical Trial Protocol Description:

This study is accepting patients at both Rush University Medical Center and Rush Copley Medical Center. Please see contact information below to join the study at one location.

This randomized phase III trial studies how well paclitaxel, trastuzumab, and pertuzumab with or without atezolizumab works in treating patients with breast cancer that has spread to other parts of the body (metastatic). Drugs used in chemotherapy, such as paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Trastuzumab is a form of "targeted therapy" because it works by attaching itself to specific molecules (receptors) on the surface of cancer cells, known as HER2 receptors. When trastuzumab attaches to HER2 receptors, the signals that tell the cells to grow are blocked and the cancer cell may be marked for destruction by the body's immune system. Monoclonal antibodies, such as pertuzumab, may interfere with the ability of cancer cells to grow and spread. Immunotherapy with monoclonal antibodies, such as atezolizumab, may induce changes in body's immune system and may interfere with the ability of tumor cells to grow and spread. It is not yet known whether giving paclitaxel, trastuzumab, and pertuzumab with or without atezolizumab may kill more tumor cells.

Clinical Trial Eligibility Criteria:

In order to participate you must meet the following criteria:

  • Have histologically confirmed adenocarcinoma of the breast with locally recurrent, unresectable disease or metastatic disease confirmed as described bby the following:
    • De novo metastatic disease presenting without prior history of HER2-positive breast cancer:
      • Diagnosis should have been made from a biopsy of a metastatic disease site, but biopsy from the breast primary or involved regional lymph nodes is acceptable if biopsy of the metastatic sites was thought to carry excessive risk for the patient.
    • Locally recurrent or metastatic disease following prior therapy for early breast cancer:
      • Diagnosis must have been made from the biopsy of the locally recurrent or metastatic disease.
      • There must be an interval of >= 6 months between completion of neoadjuvant/adjuvant HER2-targeted therapy and documentation of locally recurrent or metastatic HER2-positive disease by biopsy.

You will be excluded from the study if any of the following criteria apply to you:

  • Have metastatic disease limited to the CNS.

This is a partial list of inclusion and exclusion criteria.

Study Details

Clinical Trial Investigator at Rush University Medical Center

Melody A. Cobleigh, MD

Rush University Medical Center Contact Information

Rush Cancer Center Clinical Trials Office

Clinical Trial Investigator at Rush Copley Medical Center

Joseph T. Meschi, MD

Rush Copley Medical Center Contact Information

Amanda Baker