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BREAST: Metastatic: Phase 1: Immunotherapy combination: “GO29831- Metastatic”

A Phase Ib, Open-Label Study Evaluating the Safety and Pharmacokinetics of Atezolizumab (Anti-PD-L1 Antibody) in Combination with Trastuzumab Emtansine or With Trastuzumab and Pertuzumab (With and Without Docetaxel) in Patients With HER2-Positive BReast Cancer and Atezolizumab With Doxorubicin and Cyclophosphamide in HER2-Negative Breast Cancer

Title
Genentech GO29831
Study Title

A Phase Ib, Open-Label Study Evaluating the Safety and Pharmacokinetics of Atezolizumab (Anti-PD-L1 Antibody) in Combination with Trastuzumab Emtansine or With Trastuzumab and Pertuzumab (With and Without Docetaxel) in Patients With HER2-Positive BReast Cancer and Atezolizumab With Doxorubicin and Cyclophosphamide in HER2-Negative Breast Cancer

Site Link
Malignancy
Breast, Metastatic HER2 positive breast cancer
Stage
Disease Setting
Metastatic/Palliative
Line Of Therapy
1st line for HER2+, 1st-3rd line for HER2-
Investigational Agent
Atezolizumab
Drug Class
PD-L1 antibody
PI
Greg Vidal, MD
Sponsor
Hoffmann-La Roche
Phase
Status
Key Eligibility Criteria
Key Eligibility Criteria Details
  • Men or women

  • Metastatic or locally advanced or recurrent breast cancer

  • If HER2 negative, no more than two prior chemotherapy lines in metastatic disease and no prior anthracycline

  • Must have prior treatment with a taxane and trastuzumab in any setting

    • If treated in 2nd line or later, must have progressive disease since last regimen

    • If treated in 1st line metastatic, must have progression within 6 months of completing adjuvant therapy

  • Tumor specimen must be obtained after the most recent breast cancer systemic therapy

  • ECOG PS 0-2

  • Measurable disease

  • LVEF >50% by ECHO or MUGA

  • Adequate labs

  • No known CNS disease except for treated asymptomatic supratentorial mets with no need for active steroids

  • No leptomeningeal disease

  • No grade 2 or higher peripheral neuropathy
  • No history of autoimmune disease or need for current immunosuppressants
  • No HVB/HCV/HIV

 

Objective

Primary- DLTs, Safety; Secondary- Anti-therapeutic antibody, VS results, number of cycles received, PK

Assessment Frequency
_
Assessment Frequency 2
_



Assessment Frequency Link
Path
Any HER2 status, Any ER status
Dosing Frequency
Control Agents
N/A
Study Protocol
Randomized
No
X