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Brief Title: 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
Official Title: A Randomized, Phase II, Multi-Center, Placebo-Controlled Study of Ipatasertib (GDC-0068), an Inhibitor of Akt, in Combination With Paclitaxel as Front-Line Treatment for Patients With Metastatic Triple-Negative Breast Cancer
Study ID: NCT02162719
Brief 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.
Detailed Description:
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: FEMALE
Healthy Volunteers: No
St Jude Heritage Medical Group, Fullerton, California, United States
Cedars Sinai Medical Center, Los Angeles, California, United States
Cancer Care Assoc Med Group, Los Angeles, California, United States
UCLA Medical Center, Santa Monica, California, United States
Holycross Medical Group, Fort Lauderdale, Florida, United States
Memorial Healthcare System, Hollywood, Florida, United States
Hematology Oncology Associates of the Treasure Coast, Port Saint Lucie, Florida, United States
Rush University Medical Center, Chicago, Illinois, United States
Cancer Center of Kansas, Wichita, Kansas, United States
Massachusetts General Hospital Cancer Center, Boston, Massachusetts, United States
Comprehensive Cancer Centers of Nevada, Henderson, Nevada, United States
Carolinas Healthcare System, Charlotte, North Carolina, United States
The WEST CLINIC, P.C., Memphis, Tennessee, United States
MD Anderson Cancer Center, Houston, Texas, United States
Northern Utah Associates, Ogden, Utah, United States
Northwest Medical Specialties, Lakewood, Washington, United States
West Virginia University Hospitals Inc, Morgantown, West Virginia, United States
Sint Augustinus Wilrijk, Wilrijk, , Belgium
Institut Bergonié Centre Régional de Lutte Contre Le Cancer de Bordeaux Et Sud Ouest, Bordeaux, , France
Centre Francois Baclesse, Caen, , France
Centre Régional de Lutte Contre Le Cancer Val D'aurelle Paul Lamarque, Montpellier, , France
Hopital Saint Louis; Oncologie Medicale, Paris, , France
Clinique Armoricaine de Radiol, Saint Brieuc, , France
Istituto Nazionale Tumori Fondazione G. Pascale, Napoli, Campania, Italy
Istituto Nazionale dei Tumori; Divisione Oncologia Chirurgica e Ginecologica, Milano, Lombardia, Italy
Istituto Oncologico Veneto IRCCS Farmacia Ospedaliera, Padova, Veneto, Italy
National Cancer Center, Goyang-si, , Korea, Republic of
Seoul National University Bundang Hospital, Seongnam-si, , Korea, Republic of
Seoul National University Hospital, Seoul, , Korea, Republic of
Severance Hospital, Yonsei University Health System, Seoul, , Korea, Republic of
Asan Medical Center, Seoul, , Korea, Republic of
Korea University Guro Hospital, Seoul, , Korea, Republic of
National University Hospital; National University Cancer Institute, Singapore (NCIS), Singapore, , Singapore
National Cancer Centre, Singapore, , Singapore
Hospital Universitari Vall d'Hebron, Barcelona, , Spain
Institut Catala d Oncologia Hospital Duran i Reynals, Barcelona, , Spain
Complejo Hospitalario de Jaen, Jaen, , Spain
MD Anderson Cancer Center, Madrid, , Spain
HOSPITAL DE MADRID NORTE SANCHINARRO- CENTRO INTEGRAL ONCOLOGICO CLARA CAMPAL; Servicio de Farmacia, Madrid, , Spain
Hospital Virgen del Rocio, Sevilla, , Spain
China Medical University Hospital, North Dist., , Taiwan
Chi Mei Medical Center, Yong kang; Endocrinology, Tainan, , Taiwan
National Taiwan University Hospital, Taipei, , Taiwan
Chang Gung Medical Foundation - Linkou; Dept of Surgery, Taoyuan, , Taiwan
Name: Clinical Trials
Affiliation: Hoffmann-La Roche
Role: STUDY_DIRECTOR