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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
A Randomized, Double-Blind, Phase III Trial of Taxane/Trastuzumab/Pertuzumab With Atezolizumab or Placebo in First-Line HER2-Positive Metastatic Breast Cancer
 
Region Sponsors
Colorado
National Cancer Institute (NCI)
 
Acronym KP IRB No.
1765353
 
Study Type Phase
Clinical Trial Phase III
 
Study Population Description
(Adult, Older Adult) Male and Female with Breast Adenocarcinoma, Metastatic Breast Adenocarcinoma, Recurrent Breast Carcinoma, Stage III Breast Cancer AJCC v7 Stage IIIA Breast Cancer AJCC v7 Stage IIIB Breast Cancer AJCC v7 Stage IIIC Breast Cancer AJCC v7 Stage IV Breast Cancer AJCC v6 and v7 Unresectable Breast Carcinoma
 
Purpose
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). Chemotherapy drugs, 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.
 
Detailed Description
 
Gender Age Limit
Male & Female 18 years & older
 
Inclusion Criteria
  • The patient must have signed and dated an Institutional Review Board (IRB)-approved consent form that conforms to federal and institutional guidelines
  • Patient must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
  • Histologically confirmed adenocarcinoma of the breast with locally recurrent, unresectable disease or metastatic disease outside the central nervous system (CNS) confirmed as described below, eligible patients include those with either: * 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
  • Patients must have measurable disease based on RECIST 1.1, as determined by the site, which has not been irradiated to be eligible
  • Please contact study team for additional inclusion criteria
 
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
  • Leptomeningeal carcinomatosis
  • History of systemic anti-cancer therapy (e.g., chemotherapy, targeted therapy) for metastatic breast cancer (MBC) except as described in inclusion criteria
  • History of exposure to cumulative doses of doxorubicin greater than 360 mg per square meter of body-surface area or its equivalent
  • Please contact study team for additional exclusion criteria

 
Keywords and/or Specific Medical Conditions
  • Adenocarcinoma
  • Mitosis Modulators
  • Albumin-Bound Paclitaxel
  • Molecular Mechanisms of Pharmacological Action
  • Antibodies
  • Neoplasms
  • Antibodies, Monoclonal
  • Neoplasms by Histologic Type
  • Antimitotic Agents
  • Neoplasms by Site
  • Antineoplastic Agents
  • Neoplasms, Glandular and Epithelial
  • Antineoplastic Agents, Immunological
  • NRG-BR004
  • Antineoplastic Agents, Phytogenic
  • Paclitaxel
  • Atezolizumab
  • Pertuzumab
  • Breast Diseases
  • Physiological Effects of Drugs
  • Breast Neoplasms
  • Skin Diseases
  • Carcinoma
  • Trastuzumab
  • Docetaxel
  • Tubulin Modulators
  • Immunoglobulins
  • Oncology (Adult)
  • Immunologic Factors
 
KP Clinical Facility
  • Franklin Medical Offices - Denver
  • Lone Tree Medical Offices - Lone Tree
  • Rock Creek Medical Offices - Lafayette
 
Clinical Area
  • Oncology (Adult)


Principal Investigator:
Alex Menter, MD
Contact Information:
- Kristi Bronkan, PharmD
-(303) 720-2685
-Lone Tree Medical Offices - Lone Tree


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