Spots Global Cancer Trial Database for Basket Study of Tucatinib and Trastuzumab in Solid Tumors With HER2 Alterations
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Trial Identification
Brief Title: Basket Study of Tucatinib and Trastuzumab in Solid Tumors With HER2 Alterations
Official Title: A Phase 2 Basket Study of Tucatinib in Combination With Trastuzumab in Subjects With Previously Treated, Locally Advanced Unresectable or Metastatic Solid Tumors Driven by HER2 Alterations
Study ID: NCT04579380
Study Description
Brief Summary: This trial studies how well tucatinib works for solid tumors that make either more HER2 or a different type of HER2 than usual (HER2 alterations) The solid tumors studied in this trial have either spread to other parts of the body (metastatic) or cannot be removed completely with surgery (unresectable). All participants will get both tucatinib and trastuzumab. People with hormone-receptor positive breast cancer will also get a drug called fulvestrant. The trial will also look at what side effects happen. A side effect is anything a drug does besides treating cancer.
Detailed Description: There are multiple cohorts in this trial: * 5 tumor specific cohorts with HER2 overexpression/amplification (cervical cancer, uterine cancer, biliary tract cancer, urothelial cancer, and non-squamous non-small cell lung cancer \[NSCLC\]) * 2 tumor specific cohorts with HER2 mutations (non-squamous NSCLC and breast cancer) * 2 cohorts which will enroll all other HER2 amplified/overexpressed solid tumor types (except breast cancer, gastric or gastroesophageal junction adenocarcinoma \[GEC\], and colorectal cancer \[CRC\]) or HER2-mutated solid tumor types.
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Arizona Oncology Associates, PC - HAL, Goodyear, Arizona, United States
HonorHealth, Phoenix, Arizona, United States
Mayo Clinic Arizona, Phoenix, Arizona, United States
Arizona Cancer Center / University of Arizona, Tucson, Arizona, United States
UC San Diego / Moores Cancer Center, La Jolla, California, United States
Pacific Shores Medical Group, Long Beach, California, United States
Rocky Mountain Cancer Centers, Boulder, Colorado, United States
Regional Cancer Care Associates, Manchester, Connecticut, United States
Lombardi Cancer Center / Georgetown University Medical Center, Washington, District of Columbia, United States
Mayo Clinic Florida, Jacksonville, Florida, United States
H. Lee Moffitt Cancer Center and Research Institute, Tampa, Florida, United States
University Cancer & Blood Center, LLC, Athens, Georgia, United States
Massachusetts General Hospital, Boston, Massachusetts, United States
Mayo Clinic Rochester, Rochester, Minnesota, United States
HealthPartners Institute, Saint Louis Park, Minnesota, United States
Washington University in St Louis, Saint Louis, Missouri, United States
Nebraska Cancer Specialists, Omaha, Nebraska, United States
NYU Langone Hospital, Mineola, New York, United States
NYU Langone Hospital, New York, New York, United States
Mount Sinai Medical Center, New York, New York, United States
Duke University Medical Center, Durham, North Carolina, United States
Case Western Reserve University / University Hospitals Cleveland Medical Center, Cleveland, Ohio, United States
James Cancer Hospital / Ohio State University, Columbus, Ohio, United States
University of Pittsburgh Medical Center (UPMC)/Hillman Cancer Center, Pittsburgh, Pennsylvania, United States
Prisma Health, Greenville, South Carolina, United States
Tennessee Oncology-Nashville/Sarah Cannon Research Institute, Nashville, Tennessee, United States
Texas Oncology - West Texas, Abilene, Texas, United States
Texas Oncology, P.A. - Dallas, Dallas, Texas, United States
MD Anderson Cancer Center / University of Texas, Houston, Texas, United States
Texas Oncology - Waco, Waco, Texas, United States
Huntsman Cancer Institute/University of Utah, Salt Lake City, Utah, United States
Virginia Cancer Specialists, PC, Fairfax, Virginia, United States
Seattle Cancer Care Alliance / University of Washington, Seattle, Washington, United States
Northwest Cancer Specialists, P.C., Vancouver, Washington, United States
Carbone Cancer Center / University of Wisconsin, Madison, Wisconsin, United States
Cliniques Universitaires Saint Luc, Brussels, Other, Belgium
Grand Hopital de Charleroi, Charleroi, Other, Belgium
Universitair Ziekenhuis Antwerpen, Edegem, Other, Belgium
Academisch Ziekenhuis Groeninge, Kortrijk, Other, Belgium
CHU de Liege, Liege, Other, Belgium
AZ Sint-Maarten, Mechelen, Other, Belgium
Charite Universitatsmedizin Berlin, Berlin, Other, Germany
IRCCS Istituto Romagnolo per lo Studio dei Tumori Dino Amadori- IRST S.r.l, Meldola, Other, Italy
Istituto Europeo di Oncologia, Milano, Other, Italy
Fondazione IRCCS San Gerardo dei Tintori, Monza, Other, Italy
National Cancer Center Hospital, Chuo-Ku, Other, Japan
National Cancer Center Hospital East, Kashiwa-shi, Other, Japan
St. Marianna University School of Medicine, Kawasaki-shi, Other, Japan
Aichi Cancer Center, Nagoya-shi, Other, Japan
Kindai University Hospital, Osakasayama, Other, Japan
The Cancer Institute Hospital of JFCR, Tokyo, Other, Japan
Seoul National University Bundang Hospital, Seongnam-si, Other, Korea, Republic of
Seoul National University Hospital, Seoul, Other, Korea, Republic of
Samsung Medical Center, Seoul, Other, Korea, Republic of
Seoul National University Boramae Medical Center, Seoul, Other, Korea, Republic of
Severance Hospital, Yonsei University Health System, Seoul, Other, Korea, Republic of
Netherlands Cancer Institute, Amsterdam, Other, Netherlands
Med Polonia Sp. z o. o., Poznan, Other, Poland
Hospital Universitario Vall d'Hebron, Barcelona, Other, Spain
L'Institut Catala d'Oncologia, L'Hospitalet de Llobregat, Other, Spain
Hospital Universitario 12 de Octubre, Madrid, Other, Spain
Hospital Clinico Universitario de Santiago de Compostela, Santiago de Compostela, Other, Spain
Hospital Clinico Universitario de Valencia, Valencia, Other, Spain
The Royal Marsden Hospital, London, Other, United Kingdom
Sarah Cannon Research Institute UK, London, Other, United Kingdom
The Royal Marsden Hospital (Surrey), Sutton, Other, United Kingdom
Guy's Hospital, London, , United Kingdom
Contact Details
Name: Jorge Ramos, DO
Affiliation: Seagen Inc.
Role: STUDY_DIRECTOR
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