Status:
Recruiting
Diagnosis:
- Locally recurrent or metastatic HER2+
Phase:
Official Title:
A Randomized, Double-Blind, Phase III Trial of Paclitaxel/Trastuzumab/Pertuzumab with Atezolizumab or Placebo in First-Line HER2-Positive Metastatic Breast Cancer
NCT ID:
NCT#03199885
Link to Full Details:
Investigators:
- Dr. Mark Olsen
Description:
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. 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. Immunotherapy with trastuzumab, pertuzumab, and 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.
Eligibility:
Female – 18 years and older
Inclusion Criteria:
- Locally advanced/unresectable or metastatic disease
- Must have measurable disease per RECIST 1.1
- Tissue submission required for central testing
- ECOG 0-1
Exclusion Criteria:
- Metastatic disease limited to CNS
- Uncontrolled hypertension
- Active hepatitis
- HIV positive