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A Study Of Ipatasertib in Combination With Atezolizumab and Paclitaxel as a Treatment for Participants With Locally Advanced or Metastatic Triple-Negative Breast Cancer.
Overall Recruitment Status: Active, currently enrolling
 
Official Title
A Phase III, Double-blind, Placebo-controlled, Randomized Study Of Ipatasertib in Combination With Atezolizumab and Paclitaxel as a Treatment for Participants With Locally Advanced Unresectable or Metastatic Triple-Negative Breast Cancer.
 
Region Sponsors
California - Northern
Genentech, Inc.
 
Acronym KP IRB No.
1557816
 
Study Type Phase
Clinical Trial Phase III
 
Study Population Description
Individuals with Histologically documented Triple-Negative Breast Cancer
 
Purpose
This study will evaluate the efficacy and safety of ipatasertib in combination with atezolizumab and paclitaxel in locally advanced or metastatic Triple-Negative Breast Cancer (TNBC) previously untreated in this setting.
 
Detailed Description
This study will evaluate the efficacy, safety and pharmacokinetics of ipatasertib in combination with atezolizumab and paclitaxel in locally advanced unresectable or metastatic triple-negative breast cancer (TNBC) previously untreated in this setting. Participants with Programmed Death-Ligand 1 (PD-L1) non-positive and PD-L1 positive tumors will be independently enrolled in Cohorts 1 and 2, respectively. The combination of ipatasertib, atezolizumab and paclitaxel will be evaluated in Cohorts 1 and 2 and the combination of ipatasertib and paclitaxel will be evaluated in Cohort 1.
 
Gender Age Limit
Male & Female
 
Inclusion Criteria
  • Willingness and ability to complete all study-related assessments, including PRO assessments, in the investigator's judgement
  • 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
  • Measurable disease according to RECIST v1.1
  • Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1
  • 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
  • Appropriate candidate for paclitaxel monotherapy if tumor PD-L1 status is unknown or non-positive, appropriate candidate for paclitaxel and atezolizumab if tumor PD-L1 status is positive
  • Histologically documented triple-negative adenocarcinoma of the breast that is locally advanced or metastatic and is not amenable to resection with curative intent
 
Exclusion Criteria
  • 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
  • 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
  • Please contact study team for more eligibility criteria

 
Keywords and/or Specific Medical Conditions
  • Antibodies, Monoclonal
  • Neoplasms by Site
  • Atezolizumab
  • Paclitaxel
  • Breast Diseases
  • Skin Diseases
  • Breast Neoplasms
  • Triple Negative Breast Neoplasms
  • Neoplasms
  • Oncology (Adult)
 
KP Clinical Facility
  • Diablo Medical Center-Walnut Creek
  • Hayward Medical Center
  • Oakland Medical Center
  • Roseville Medical Center
  • Sacramento Medical Center
  • San Francisco Medical Center
  • San Leandro Medical Center
  • Santa Clara Medical Center-Homestead
  • Santa Teresa Medical Center-San Jose
  • South San Francisco Medical Center
  • Vallejo Medical Center
 
Clinical Area
  • Oncology (Adult)


Principal Investigator:
Marie Marie Suga, MD
Contact Information:
- Oncology Clinical Trials KPNC
-amber.n.rodori@kp.org
-San Leandro Medical Center


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