breast cancer
Conditions
Sponsors
Chugai Pharmaceutical Co., Ltd.
F. Hoffmann-La Roche Ltd
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Willingness and ability to complete all study-related assessments, including PRO assessments, in the investigator's judgement. - Adequate hematologic and organ function. - 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
Exclusion criteria: - 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. - Known germline BRCA1/2 deleterious mutation, unless the participant is not an appropriate candidate for a PARP-inhibitor. - Any previous systemic therapy for inoperable locally advanced or metastatic triple-negative adenocarcinoma of the breast. - Malignancies other than breast cancer within 5 years prior to Day 1 of Cycle 1, except for appropriately treated carcinoma in situ of the cervix, non-melanoma skin carcinoma, or Stage I uterine cancer. - Known hypersensitivity or contraindication to any component of the study treatments. - History of Type I or Type II diabetes mellitus requiring insulin. - History of or active inflammatory bowel disease (e.g., Crohn disease and ulcerative colitis) or active bowel inflammation (e.g., diverticulitis). - Prior treatment with an Akt inhibitor. - Active or history of autoimmune disease or immune deficiency.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| efficacy - Progression Free Survival (PFS) - Overall Survival (OS) | — |
Secondary
| Measure | Time frame |
|---|---|
| safety efficacy pharmacokinetics pharmacodynamics pharmacogenomics - Overall Response Rate (ORR) - Duration of Response (DOR) - Clinical Benefit Rate (CBR) - Mean and mean changes from baseline score in function in participant-reported Global Health Status (GHS)/Quality of Life (QoL) by assessment timepoint and between treatment arms - Number of Participants with Adverse Events (AEs) - Plasma concentration of ipatasertib and its metabolite (G037720) (ng/mL) at specified timepoints - Serum concentration of atezolizumab (ug/mL) at specified timepoints - Level of Anti-Drug Antibodies (ADAs) (%) to Atezolizumab | — |
Countries
Africa, Asia except Japan, Central America, Europe, Japan, North America, Oceania, South America
Outcome results
None listed