Breast Cancer Clinical Trial
A Study Assessing the Safety and Efficacy of Adding Ipatasertib to Paclitaxel Treatment in Participants With Breast Cancer That Has Spread Beyond the Initial Site, and the Cancer Does Not Have Certain Hormonal Receptors
Summary
This multicenter, randomized, double-blind study will estimate the efficacy, safety and tolerability of ipatasertib combined with paclitaxel compared with placebo combined with paclitaxel in participants with inoperable locally advanced or metastatic triple-negative breast cancer (mTNBC), as measured by progression-free survival (PFS) in all participants and in participants with phosphatase and tensin homolog (PTEN)-low tumors.
Eligibility Criteria
Inclusion Criteria:
Histologically documented triple-negative adenocarcinoma of the breast that is inoperable locally advanced or metastatic and is not amenable to resection with curative intent
Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
Availability of a representative formalin-fixed, paraffin-embedded (FFPE) tumor specimen, required prior to randomization
Measurable disease, according to the RECIST v1.1
Adequate hematologic and organ function within 14 days before the first study treatment
For female participants of childbearing potential, agreement (by both participant and partner) to use an effective form of contraception for the duration of the study and for 6 months after last dose of study treatment
Exclusion Criteria:
Any previous therapy, including chemotherapy or hormonal or targeted therapy, for inoperable locally advanced or metastatic triple-negative adenocarcinoma of the breast. Participants may have received prior neoadjuvant or adjuvant chemotherapy and/or radiation treatment for locally advanced triple negative adenocarcinoma, provided all treatments were completed greater than or equal to (>/=) 6 months prior to Cycle 1 Day 1. Locally recurrent disease must not be amenable to resection with curative intent
Any radiation treatment to metastatic site within 28 days of Cycle 1, Day 1
Known Human Epidermal Growth Factor Receptor 2 (HER2) positive, erythrocyte receptor (ER) positive, or progesterone receptor (PR) positive breast cancer
Previous therapy with Akt, PI3K, and/or mTOR inhibitors
Major surgical procedure, open biopsy, or significant traumatic injury within 30 days prior to Cycle 1, Day 1 or anticipation of need for a major surgical procedure during the course of the study
Known presence of the brain or spinal cord metastasis, as determined by computed tomography (CT) or magnetic resonance imaging (MRI) evaluation during screening or prior radiographic assessments
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There are 44 Locations for this study
Fullerton California, 92835, United States
Los Angeles California, 90048, United States
Los Angeles California, 90095, United States
Santa Monica California, 90404, United States
Fort Lauderdale Florida, 33308, United States
Hollywood Florida, 33021, United States
Port Saint Lucie Florida, 34952, United States
Chicago Illinois, 60612, United States
Wichita Kansas, 67214, United States
Boston Massachusetts, 02114, United States
Henderson Nevada, 89014, United States
Charlotte North Carolina, 28208, United States
Memphis Tennessee, 38119, United States
Houston Texas, 77030, United States
Ogden Utah, 84403, United States
Lakewood Washington, 98499, United States
Morgantown West Virginia, 26056, United States
Wilrijk , 2610, Belgium
Bordeaux , 33076, France
Caen , 14076, France
Montpellier , 34298, France
Paris , 75475, France
Saint Brieuc , 22015, France
Napoli Campania, 80131, Italy
Milano Lombardia, 20133, Italy
Padova Veneto, 35128, Italy
Goyang-si , 10408, Korea, Republic of
Seongnam-si , 13605, Korea, Republic of
Seoul , 03080, Korea, Republic of
Seoul , 03722, Korea, Republic of
Seoul , 05505, Korea, Republic of
Seoul , 08308, Korea, Republic of
Singapore , 11922, Singapore
Singapore , 16961, Singapore
Barcelona , 08035, Spain
Barcelona , 08908, Spain
Jaen , 23007, Spain
Madrid , 28033, Spain
Madrid , 28050, Spain
Sevilla , 41013, Spain
North Dist. , 40402, Taiwan
Tainan , 710, Taiwan
Taipei , 10002, Taiwan
Taoyuan , 333, Taiwan
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