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Spots Global Cancer Trial Database for 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

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Trial Identification

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

Study Description

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:

Keywords

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: FEMALE

Healthy Volunteers: No

Locations

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

Contact Details

Name: Clinical Trials

Affiliation: Hoffmann-La Roche

Role: STUDY_DIRECTOR

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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