A Phase III Study of MPDL3280A (Atezolizumab) with Previously Untreated Locally Advanced or Metastatic Breast Cancer (IMpassion131)
Phase 3
Completed
- Conditions
- Triple-Negative Breast Cancer
- Registration Number
- JPRN-jRCT2080223759
- Lead Sponsor
- CHUGAI PHARMACEUTICAL CO., LTD.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- completed
- Sex
- All
- Target Recruitment
- 18
Inclusion Criteria
Metastatic or locally advanced, histologically documented Triple-Negative Breast Cancer (TNBC)
- No prior chemotherapy or targeted systemic therapy for inoperable locally advanced or metastatic TNBC
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Measurable disease
- Adequate hematologic and end-organ function
Exclusion Criteria
- Known central nervous system (CNS) disease, except for treated asymptomatic CNS metastases
- Leptomeningeal disease
- Pregnancy or lactation
- Uncontrolled pleural effusion, pericardial effusion, or ascites
- Uncontrolled tumor-related pain, or uncontrolled hypercalcemia
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method efficacy<br>RECIST v1.1
- Secondary Outcome Measures
Name Time Method efficacy<br>safety<br>RECIST v1.1, Obserbation