A Study to Evaluate the Safety and Efficacy of Ipatasertib in Combination With Atezolizumab and Paclitaxel or Nab-Paclitaxel in Participants With Locally Advanced or Metastatic Triple-Negative Breast Cancer



Status:Recruiting
Conditions:Breast Cancer, Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:3/31/2019
Start Date:February 13, 2018
End Date:May 13, 2020
Contact:Reference Study ID Number: CO40151 www.roche.com/about_roche/roche_worldwide.htm
Email:global.rochegenentechtrials@roche.com
Phone:888-662-6728 (U.S. and Canada)

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A Phase Ib, Open-Label, Multicenter Study Evaluating the Safety and Efficacy of Ipatasertib in Combination With Atezolizumab and Paclitaxel or Nab-Paclitaxel in Patients With Locally Advanced or Metastatic Triple-Negative Breast Cancer

This is a Phase Ib, open-label, multicenter study evaluating the safety and efficacy of
ipatasertib in combination with atezolizumab and paclitaxel or nab-paclitaxel for patients
with locally advanced or metastatic triple-negative breast cancer (mTNBC) who have not
previously received chemotherapy in the advanced setting. Two triplets; ipatasertib in
combination with atezolizumab and paclitaxel (Paclitaxel arm) and ipatasertib in combination
with atezolizumab and nab-paclitaxel (Nab-Paclitaxel arm) are being evaluated for first-line
chemotherapy treatment for advanced TNBC. Cohort 1 will evaluate first-line chemotherapy
treatment in advanced TNBC patients and Cohort 2 will contain biopsy assessments of TNBC
patients who have progressed after at least one line of chemotherapy in the advanced setting.


Inclusion Criteria:

- Eastern Cooperative Oncology Group Performance Status of 0 or 1

- Adequate hematologic and organ function

- Life expectancy of at least 6 months

- For men and women of child bearing potential: agreement to remain abstinent or use
protocol defined contraceptive measures during the treatment period and for at least
28 days after the last dose of ipatasertib, 6 months after the last dose of
paclitaxel, and 5 months after the last dose of atezolizumab, whichever occurs later

- Histologically documented TNBC that is locally advanced or metastatic

- Measurable disease according to RECIST v1.1

Exclusion Criteria:

- 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

- History of or current evidence of HIV infection

- Known clinically significant history of liver disease

- Pregnant or breastfeeding

- Left ventricular ejection fraction < 50%

- Prior treatment with an Akt inhibitor

- History of or known presence of brain or spinal cord metastases

- Patients may have received prior neoadjuvant or adjuvant chemotherapy and/or radiation
treatment for early stage breast cancer, provided all chemotherapy was completed >= 12
months prior to Day 1 of Cycle 1

- Uncontrolled tumor related complications

- Malignancies other than breast cancer within 5 years prior to Day 1 of Cycle 1

- History of Type I or Type II diabetes mellitus requiring insulin

- Uncontrolled or untreated hypercholesterolemia or hypertriglyceridemia

- History of or active inflammatory bowel disease or active bowel inflammation

- Clinically significant lung disease

- Treatment with strong CYP3A inhibitors or strong CYP3A inducers

- Active or history of autoimmune disease or immune deficiency

- Prior allogeneic stem cell or solid organ transplantation

- History of hypersensitivity reactions to study drug or any component of the study drug
formulation

- Treatment with systemic immunostimulatory agents and immunosuppressive medication
treatment, or anticipation of need for systemic immunosuppressive medication during
the course of the study

- Grade >= 2 peripheral neuropathy
We found this trial at
3
sites
Tacoma, Washington 98405
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Tacoma, WA
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Darlinghurst,
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Long Beach, California 90813
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Long Beach, CA
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