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Brief Title: A Study of LOXO-783 in Patients With Breast Cancer/Other Solid Tumors
Official Title: A Study of LOXO-783 Administered as Monotherapy and in Combination With Anticancer Therapies for Patients With Advanced Breast Cancer and Other Solid Tumors With a PIK3CA H1047R Mutation
Study ID: NCT05307705
Brief Summary: The main purpose of this study is to learn more about the safety, side effects, and effectiveness of LOXO-783. LOXO-783 may be used to treat breast cancer and other solid tumors that have a change in a particular gene (known as the PIK3CA gene). Participation could last up to 36 months (3 years) and possibly longer if the disease does not get worse.
Detailed Description:
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Mayo Clinic of Scottsdale, Scottsdale, Arizona, United States
Stanford University, Palo Alto, California, United States
UCSF, San Francisco, California, United States
UCLA, Santa Monica, California, United States
Mayo Clinic-Jacksonville, Jacksonville, Florida, United States
Emory University, Atlanta, Georgia, United States
Massachusetts General Hospital, Boston, Massachusetts, United States
DFCI, Boston, Massachusetts, United States
Mayo Clinic, Rochester, Minnesota, United States
Washington University Medical School, Saint Louis, Missouri, United States
Memorial Sloan Kettering Cancer Center, New York, New York, United States
Wilmot Cancer Institute, Rochester, New York, United States
Tennessee Oncology PLLC, Nashville, Tennessee, United States
Texas Oncology-Baylor Charles A. Sammons Cancer Center, Dallas, Texas, United States
UT Southwestern Medical Center, Dallas, Texas, United States
University of Texas MD Anderson Cancer Center, Houston, Texas, United States
South Texas Accelerated Research Therapeutics (START), San Antonio, Texas, United States
St Vincent's Hospital Sydney, Sydney, New South Wales, Australia
Cancer Research SA, Adelaide SA, , Australia
Peter MacCallum Cancer Center, Melbourne, , Australia
Institut Jules Bordet Brussels, Brussels, , Belgium
Universitaire Ziekenhuizen Leuven - Campus Gasthuisberg, Leuven, , Belgium
Princess Margaret Hospital, Toronto, , Canada
BC Cancer Center, Vancouver, , Canada
Beijing Cancer Hospital, Beijing, , China
Hunan Cancer Hospital, Changsha, , China
Third Hospital of Nanchang, Nanchang, , China
Fudan University Cancer Center, Shanghai, , China
Institut de Cancérologie de l'Ouest, Angers, , France
Centre François Baclesse, Caen, , France
Centre Leon Berard, Lyon, , France
Institut Curie, Paris, , France
ICANS Strasbourg, Strasbourg, , France
Gustave Roussy, Villejuif, , France
Klinikum der Johann Wolfgang Goethe-Universität Frankfurt, Frankfurt, Hessen, Germany
Universitaetsklinikum Tuebingen, Tuebingen, Württemberg, Germany
Universitätsklinikum Erlangen, Erlangen, , Germany
Istituto Europeo di Oncologia IRCCS, Milano, , Italy
Aichi Cancer Center Hospital, Nagoya, Aichi, Japan
National Cancer Center Hospital, Chuo-ku, Tokyo, Japan
The Cancer Institute Hospital of JFCR, Koto City, Tokyo, Japan
Kyoto University Hospital, Kyoto, , Japan
Asan Medical Center, Seoul, , Korea, Republic of
Samsung Medical Center, Seoul, , Korea, Republic of
National Cancer Center, Singapore, , Singapore
Hospital Universitari Quiron Dexeus, Barcelona, , Spain
Vall d'Hebron, Barcelona, , Spain
Hospital Clinic y Provincial de Barcelona, Barcelona, , Spain
Hospital General Universitario Gregorio Maranon, Madrid, , Spain
Hospital Universitario 12 de Octubre, Madrid, , Spain
Hospital Quironsalud Madrid, Madrid, , Spain
Hospital Clinico Universitario de Valencia, Valencia, , Spain
Hospital Arnau de Vilanova Valencia, Valencia, , Spain
Royal Marsden NHS Trust, London, Greater London, United Kingdom
Royal Marsden Hospital (Sutton) Loc. 6, Sutton, Surrey, United Kingdom
Name: Vincent Chau, MD; PhD
Affiliation: Loxo Oncology, Inc.
Role: STUDY_DIRECTOR