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Testing the Drug Atezolizumab or Placebo With Usual Therapy in First-Line HER2-Positive Metastatic Breast Cancer
Overall Recruitment Status: Active, currently enrolling
 
Official Title
NRG-BR004: A randomized, double-blind, phase III trial of paclitaxel/trastuzumab/pertuzumab with atezolizumab or placebo in first-line HER2-positive metastatic breast cancer
 
Region Sponsors
Mid-Atlantic
National Cancer Institute (NCI)
NRG Oncology
 
Acronym KP IRB No.
1603384
 
Study Type Phase
Clinical Trial Phase III
 
Study Population Description
Patients with HER2-positive metastatic breast cancer
 
Purpose
The purpose of this study is to see how well paclitaxel, trastuzumab, and pertuzumab work with or without atezolizumab in patients with metastatic breast cancer.
 
Detailed Description
This trial will determine whether the addition of atezolizumab with standard chemotherapy regimens improves invasive disease-free survival relative to chemotherapy alone. Secondary aims include determining whether the addition of atezolizumab to chemotherapy improves disease-free survival, breast cancer-free survival, recurrence-free interval, distant recurrence-free interval, and overall survival relative to chemotherapy alone. Additionally, the toxicities of the regimens are being compared. The trial will determine if the addition of this drug improves the outcome of patients with first line HER-2 positive metastatic breast cancer.
 
Gender Age Limit
Male & Female
 
Inclusion Criteria
  • HER2-positive metastatic breast cancer
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
 
Exclusion Criteria
  • Patients with brain metastases are excluded if they meet ANY of the following criteria: Symptoms from brain metastases have not resolved prior to study entry, Five or more clearly identified foci of metastases to the brain, Largest unexcised tumor exceeds 3 cm, Spinal cord metastases, Medical Oncologist plans to employ HER2-directed tyrosine kinase inhibitor as component of systemic therapy, Metastatic disease limited to CNS
  • History of systemic anti-cancer therapy
  • 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 to study entry
  • Uncontrolled hypertension
  • Cardiac disease (history of and/or active disease), allergies, history of autoimmune disease, immunosuppressive use, active/uncontrolled systemic disease etc. that would preclude the safe use of the drugs included in the treatment regimens and/or safe participation in the study

 
Keywords and/or Specific Medical Conditions
  • Breast Cancer
  • Oncology (Adult)
  • Metastatic
 
KP Clinical Facility
  • Burke Medical Center
  • Capitol Hill Medical Center
  • Gaithersburg Medical Center
  • Largo Medical Center
  • Tyson's Corner Medical Center
  • Woodlawn Medical Center
 
Clinical Area
  • Oncology (Adult)


Principal Investigator:
Leon Hwang, MD
Contact Information:
- Leslie Greenberg, MS
-Leslie.K.Greenberg@kp.org
-Gaithersburg Medical Center


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