A PHASE III, DOUBLE-BLIND,PLACEBO-CONTROLLED, RANDOMIZED STUDYOF IPATASERTIB IN COMBINATION WITHATEZOLIZUMAB AND PACLITAXEL AS ATREATMENT FOR PATIENTS WITH LOCALLYADVANCED UNRESECTABLE OR METASTATICTRIPLE-NEGATIVE BREAST CANCER..
- Conditions
- -C50 Malignant neoplasm of breastMalignant neoplasm of breastC50
- Registration Number
- PER-018-19
- Lead Sponsor
- F. Hoffmann La Roche Ltd / Genentech Inc,
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 9
• Signed Informed Consent Form(s)
• Women or men, age ≥ 18 years at the time of signing the Informed Consent Form
• Willingness and ability to complete all study-related assessments, including PRO assessments, in the investigator’s judgment.
• Measurable disease according to RECIST v1.1
Previously irradiated lesions can be considered as measurable disease only if progressive disease has been unequivocally documented at that site since radiation.
• Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1
• Adequate hematologic and organ function within 14 days before the first study treatment on
Day 1 of Cycle 1.
• Life expectancy of at least 6 months
• For women of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraception, and agreement to refrain from donating eggs.
• For men: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive methods, and agreement to refrain from donating sperm.
See protocol for more detail.
• Inability to comply with study and follow-up procedures
• History of malabsorption syndrome or other condition that would interfere with enteral
absorption or results in the inability or unwillingness to swallow pills
• Active infection requiring systemic anti-microbial treatment (including antibiotics, anti-fungal agents, and anti-viral agents)
• Known HIV infection (there must be a negative HIV test at screening)
• Known clinically significant history of liver disease consistent with Child-Pugh Class B or C, including active viral or other hepatitis.
• Current treatment with anti-viral therapy for HBV
• Major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to
Day 1 of Cycle 1 or anticipation of need for a major surgical procedure during the study.
• Pregnancy or breastfeeding, or intention to become pregnant during the study or within 28 days after the final dose of ipatasertib/placebo, 5 months after the final dose of atezolizumab/placebo, and 6 months after the final dose of paclitaxel whichever occurs later.
See protocol for more detail.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method