Basket Study of Tucatinib and Trastuzumab in Solid Tumors With HER2 Alterations
NCT ID: NCT04579380
Last Updated: 2025-12-19
Study Results
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View full resultsBasic Information
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ACTIVE_NOT_RECRUITING
PHASE2
217 participants
INTERVENTIONAL
2021-01-11
2026-04-30
Brief Summary
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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
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* 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.
Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Tucatinib + Trastuzumab (+ Fulvestrant)
Tucatinib + trastuzumab (+ fulvestrant in hormone-receptor positive HER2-mutant breast cancer only)
tucatinib
300 mg orally twice daily
trastuzumab
Given into the vein (intravenously; IV). 8mg/kg IV on Cycle 1 Day 1, and 6mg/kg every 21 days starting on Cycle 2 Day 1
fulvestrant
Given into the muscle (intramuscular; IM) once every 4 weeks starting from Cycle 1 Day 1, plus one dose on Cycle 1 Day 15. Only administered to participants with hormone-receptor positive breast cancer.
Interventions
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tucatinib
300 mg orally twice daily
trastuzumab
Given into the vein (intravenously; IV). 8mg/kg IV on Cycle 1 Day 1, and 6mg/kg every 21 days starting on Cycle 2 Day 1
fulvestrant
Given into the muscle (intramuscular; IM) once every 4 weeks starting from Cycle 1 Day 1, plus one dose on Cycle 1 Day 15. Only administered to participants with hormone-receptor positive breast cancer.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Participants with non-squamous NSCLC must have progressed during or after standard treatment or for which no standard treatment is available
* Participants with other disease types must have progressed during or after ≥1 prior line of systemic therapy for locally-advanced unresectable or metastatic disease
* Disease progression during or after, or intolerance of, the most recent line of systemic therapy
* Disease demonstrating HER2 alterations (overexpression/amplification or HER2 activating mutations), as determined by local or central testing processed in a Clinical Laboratory Improvement Amendments (CLIA)- or International Organization for Standardization (ISO) accredited laboratory, according to one of the following:
* HER2 overexpression/amplification from fresh or archival tumor tissue or blood
* Known activating HER2 mutations detected in fresh or archival tumor tissue or blood
* Have measurable disease per RECIST v1.1 criteria according to investigator assessment
* Have Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
Exclusion Criteria
* Previous treatment with HER2-directed therapy; participants with uterine serous carcinoma or HER2-mutated gastric or gastroesophageal junction adenocarcinoma without HER2-overexpression/amplification may have received prior trastuzumab
* Known hypersensitivity to any component of the drug formulation of tucatinib or trastuzumab (drug substance, excipients, murine proteins), or any component of the drug formulation of fulvestrant in participants with HR+ HER2-mutated breast cancer
* History of exposure to a 360 mg/m² doxorubicin-equivalent or \>720 mg/m\^2 epirubicin-equivalent cumulative dose of anthracyclines
* Treatment with any systemic anti-cancer therapy, radiation therapy, major surgery, or experimental agent within ≤3 weeks of first dose of study treatment or are currently participating in another interventional clinical trial.
18 Years
ALL
No
Sponsors
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Seagen, a wholly owned subsidiary of Pfizer
INDUSTRY
Responsible Party
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Principal Investigators
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Pfizer CT.gov Call Center
Role: STUDY_DIRECTOR
Pfizer
Locations
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HonorHealth
Phoenix, Arizona, United States
HonorHealth
Tempe, Arizona, United States
The University of Arizona Cancer Center-North Campus
Tucson, Arizona, United States
City of Hope at Huntington Beach
Huntington Beach, California, United States
City of Hope at Irvine Sand Canyon
Irvine, California, United States
Koman Family Outpatient Pavilion
La Jolla, California, United States
UC San Diego Medical Center - La Jolla (Jacobs Medical Center / Thornton Pavilion)
La Jolla, California, United States
UC San Diego Moores Cancer Center- Investigational Drug Services
La Jolla, California, United States
UC San Diego Moores Cancer Center
La Jolla, California, United States
City of Hope at Long Beach Worsham
Long Beach, California, United States
City of Hope at Long Beach Elm
Long Beach, California, United States
City of Hope at Newport Beach Lido
Newport Beach, California, United States
City of Hope Torrance
Torrance, California, United States
Rocky Mountain Cancer Centers
Aurora, Colorado, United States
Rocky Mountain Cancer Centers
Boulder, Colorado, United States
Rocky Mountain Cancer Centers
Thornton, Colorado, United States
Moffitt Cancer Center
Tampa, Florida, United States
Minnesota Oncology Hematology, PA
Coon Rapids, Minnesota, United States
Metro Minnesota Community Oncology Research Consortium (MMCORC)
Saint Louis Park, Minnesota, United States
Washington University School of Medicine - Obstetrics & Gynecology [Academic Offices)
St Louis, Missouri, United States
Barnes-Jewish Hospital Investigational Drug Pharmacy (IDS)
St Louis, Missouri, United States
Washington University School of Medicine - Obstetrics & Gynecology
St Louis, Missouri, United States
Washington University School of Medicine [Patient Clinics]
St Louis, Missouri, United States
Oncology Hematology West P.C. dba Nebraska Cancer Specialists
Omaha, Nebraska, United States
Oncology Hematology West P.C. dba Nebraska Cancer Specialists
Omaha, Nebraska, United States
NYU Langone Health - Long Island (Winthrop Hospital)
Mineola, New York, United States
Perlmutter Cancer Center at NYU Langone GYN Oncology Associates
Mineola, New York, United States
Perlmutter Cancer Center at NYU Langone Hospital - Long Island
Mineola, New York, United States
Laura and Isaac Perlmutter Cancer Center at NYU Langone
New York, New York, United States
NYU Langone Medical Center
New York, New York, United States
Icahn School of Medicine at Mount Sinai
New York, New York, United States
Duke University Medical Center/Duke Cancer Center
Durham, North Carolina, United States
University Hospitals Cleveland Medical Center
Cleveland, Ohio, United States
OSU Wexner Medical Center, CarePoint East
Columbus, Ohio, United States
OSU Wexner Medical Center, Ohio State University Hospital East
Columbus, Ohio, United States
OSU Wexner Medical Center, Arther G. James Cancer Hospital, and Solove Research Institute
Columbus, Ohio, United States
OSU Wexner Medical Center, Investigational Drug Services(IP Ship to)
Columbus, Ohio, United States
Osu Wexner Medical Center, The Ohio State University Hospital
Columbus, Ohio, United States
OSU Wexner Medical Center, Stephanie Spielman Comprehensive Breast Center
Columbus, Ohio, United States
OSU Wexner Medical Center, Martha Morehouse Medical Plaza
Columbus, Ohio, United States
OSU Wexner Medical Center, OutPatient Care Upper Arlington
Columbus, Ohio, United States
OSU Wexner Medical Center, CarePoint Gahanna
Gahanna, Ohio, United States
OSU Wexner Medical Center, Gynecologic Oncology at Mill Run
Hilliard, Ohio, United States
OSU Wexner Medical Center, Outpatient Care Lewis Center
Lewis Center, Ohio, United States
UH Minoff Health Center at Chagrin Highlands
Orange, Ohio, United States
OSU Wexner Medical Center, Outpatient Care New Albany
Westerville, Ohio, United States
Northwest Cancer Specialists, P.C.
Portland, Oregon, United States
Northwest Cancer Specialists, P.C.
Portland, Oregon, United States
Northwest Cancer Specialists, P.C.
Tigard, Oregon, United States
UPMC Hillman Cancer Center - Washington
Washington, Pennsylvania, United States
Prisma Health Cancer Institute
Boiling Springs, South Carolina, United States
Prisma Health Cancer Institute
Easley, South Carolina, United States
Prisma Health Cancer Institute
Greenville, South Carolina, United States
Prisma Health Cancer Institute
Greenville, South Carolina, United States
Prisma Health Cancer Institute
Greer, South Carolina, United States
Prisma Health Cancer Institute
Seneca, South Carolina, United States
Tennessee Oncology, PLLC
Gallatin, Tennessee, United States
Tennessee Oncology, PLLC
Hendersonville, Tennessee, United States
Tennessee Oncology, PLLC
Nashville, Tennessee, United States
Tennessee Oncology, PLLC
Shelbyville, Tennessee, United States
Texas oncology-West Texas
Abilene, Texas, United States
US Oncology Investigational Product Center (IPC)
Irving, Texas, United States
US Oncology Investigational Products Center (IPC)
Irving, Texas, United States
US Oncology lnvestigational Products Center (IPC)
Irving, Texas, United States
Texas Oncology - Central South
Waco, Texas, United States
Huntsman Cancer Institute, University of Utah
Salt Lake City, Utah, United States
Virginia Cancer Specialists, PC
Alexandria, Virginia, United States
Virginia Cancer Specialists, PC
Arlington, Virginia, United States
Virginia Cancer Specialists, PC
Fairfax, Virginia, United States
Virginia Cancer Specialists, PC
Gainesville, Virginia, United States
Fred Hutchinson Cancer Center
Seattle, Washington, United States
University of Washington Medical Center
Seattle, Washington, United States
Northwest Cancer Specialists, P.C.
Vancouver, Washington, United States
1 S Park St Medical Center
Madison, Wisconsin, United States
University of Wisconsin Clinical Science Center
Madison, Wisconsin, United States
Grand Hopital de Charleroi
Charleroi, Hainaut, Belgium
Cliniques Universitaires Saint-Luc
Brussels, , Belgium
Universitair Ziekenhuis Antwerpen
Edegem, , Belgium
AZ Groeninge
Kortrijk, , Belgium
CHU de Liege
Liège, , Belgium
AZ Sint-Maarten
Mechelen, , Belgium
Charite Universitatsmedizin Berlin
Berlin, , Germany
Divisione di Sviluppo di Nuovi Farmaci per Terapie Innovative lstituto Europeo di Oncologia
Milan, Milan, Italy
Aichi Cancer Center Hospital
Nagoya, Aichi-ken, Japan
National Cancer Center Hospital East
Kashiwa-shi, Chiba, Japan
St. Marianna University School of Medicine Hospital
Kawasaki, Kanagawa, Japan
Kindai University Hospital
Osakasayama-shi, Osaka, Japan
National Cancer Center Hospital
Cho-ku, Tokyo, Japan
The Cancer Institute Hospital of JFCR
Tokyo, , Japan
Seoul National University Bundang Hospital
Seongnam-si, Gyeonggi-do, South Korea
Severance Hospital Yonsei University Health System
Seoul, Other, South Korea
Seoul National University Hospital
Seoul, , South Korea
Samsung Medical Center
Seoul, , South Korea
Institut Catala d'Oncologia Hospitalet
L'Hospitalet de Llobregat, Other, Spain
Cetir Centre Medic
Barcelona, , Spain
Hospital Clínico Universitario de Valencia. Fundación Investigación Clínico de Valencia.
Valencia, , Spain
Ascires Eresa Campanar
Valencia, , Spain
Hospital Vithas Valencia 9 de Octubre
Valencia, , Spain
Sarah Cannon Research Institute UK
London, Budapest, United Kingdom
Diagnostic Centre
London, Others, United Kingdom
The Royal Marsden NHS Foundation Trust
Sutton, Surrey, United Kingdom
Guy's Hospital
London, , United Kingdom
Jonathan Poon
London, , United Kingdom
The Royal Marsden NHS Foundation Trust
London, , United Kingdom
The Harley Street Clinic
London, , United Kingdom
Radiology
London, , United Kingdom
Countries
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References
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Okines AFC, Curigliano G, Mizuno N, Oh DY, Rorive A, Soliman H, Takahashi S, Bekaii-Saab T, Burkard ME, Chung KY, Debruyne PR, Fox JR, Gambardella V, Gil-Martin M, Hamilton EP, Monk BJ, Nakamura Y, Nguyen D, O'Malley DM, Olawaiye AB, Pothuri B, Reck M, Sudo K, Sunakawa Y, Van Marcke C, Yu EY, Ramos J, Tan S, Bieda M, Stinchcombe TE, Pohlmann PR. Tucatinib and trastuzumab in HER2-mutated metastatic breast cancer: a phase 2 basket trial. Nat Med. 2025 Mar;31(3):909-916. doi: 10.1038/s41591-024-03462-0. Epub 2025 Jan 17.
Nakamura Y, Mizuno N, Sunakawa Y, Canon JL, Galsky MD, Hamilton E, Hayashi H, Jerusalem G, Kim ST, Lee KW, Kankeu Fonkoua LA, Monk BJ, Nguyen D, Oh DY, Okines A, O'Malley DM, Pohlmann P, Reck M, Shin SJ, Sudo K, Takahashi S, Van Marcke C, Yu EY, Groisberg R, Ramos J, Tan S, Stinchcombe TE, Bekaii-Saab T. Tucatinib and Trastuzumab for Previously Treated Human Epidermal Growth Factor Receptor 2-Positive Metastatic Biliary Tract Cancer (SGNTUC-019): A Phase II Basket Study. J Clin Oncol. 2023 Dec 20;41(36):5569-5578. doi: 10.1200/JCO.23.00606. Epub 2023 Sep 26.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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SGNTUC-019
Identifier Type: -
Identifier Source: org_study_id