Testing the Drug Atezolizumab or Placebo With Usual Therapy in First-Line HER2-Positive Metastatic Breast Cancer

April 22, 2020
BR-004
Breast Cancer
Joseph Kash, MD
Edward Cancer Center - Naperville
Edward Cancer Center - Plainfield
Nancy Knowles Cancer Center - Elmhurst

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.

Sponsor: NRG Oncology

https://clinicaltrials.gov/ct2/show/record/NCT03199885

  • Histologically confirmed breast adenocarcinoma with locally recurrent, unresectable disease or metastatic disease
  • The tumor must have be HER2-positive
  • Patients must have imaging of the chest/abdomen/pelvis, preferably with a computed tomography (CT) scan, and a bone scan within 4 weeks prior to randomization; (NOTE: if a patient is unable to receive CT contrast, a magnetic resonance imaging [MRI] of the abdomen/pelvis and non-contrast chest CT should be performed; positron emission tomography/computed tomography [PET/CT] is not an acceptable alternative)
  • No history of intracranial hemorrhage or spinal cord hemorrhage
  • No history of systemic anti-cancer therapy for metastatic breast cancer (MBC) with the exception of: trastuzumab, lapatinib, or loading doses of trastuzumab and pertuzumab
  • No history of non-breast malignancies (except for in situ cancers treated only by local excision and basal cell and squamous cell carcinomas of the skin) within 5 years prior
  • No uncontrolled hypertension, cardiac disease or history of cardiac disease, or history or risk of autoimmune disease

8 years

Accepting Participants
Interventional
III
Kathy Seymour, BSN
630-646-6075
630-646-6110
630-646-6072