Basket Study of Tucatinib and Trastuzumab in Solid Tumors With HER2 Alterations

PHASE2Active, not recruitingINTERVENTIONAL
Enrollment

217

Participants

Timeline

Start Date

January 11, 2021

Primary Completion Date

November 1, 2023

Study Completion Date

April 30, 2026

Conditions
Uterine NeoplasmsUterine Cervical NeoplasmsBiliary Tract NeoplasmsUrologic NeoplasmsCarcinoma, Non-Small-Cell LungHER2 Mutations Breast Neoplasms
Interventions
DRUG

tucatinib

300 mg orally twice daily

DRUG

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

DRUG

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.

Trial Locations (106)

1200

Cliniques Universitaires Saint-Luc, Brussels

2650

Universitair Ziekenhuis Antwerpen, Edegem

2800

AZ Sint-Maarten, Mechelen

4000

CHU de Liege, Liège

8500

AZ Groeninge, Kortrijk

8908

Institut Catala d'Oncologia Hospitalet, L'Hospitalet de Llobregat

10016

Laura and Isaac Perlmutter Cancer Center at NYU Langone, New York

NYU Langone Medical Center, New York

10029

Icahn School of Medicine at Mount Sinai, New York

11501

Perlmutter Cancer Center at NYU Langone GYN Oncology Associates, Mineola

Perlmutter Cancer Center at NYU Langone Hospital - Long Island, Mineola

12200

Charite Universitatsmedizin Berlin, Berlin

13353

Charite Universitatsmedizin Berlin, Berlin

13620

Seoul National University Bundang Hospital, Seongnam-si

15301

UPMC Hillman Cancer Center - Washington, Washington

20141

Divisione di Sviluppo di Nuovi Farmaci per Terapie Innovative lstituto Europeo di Oncologia, Milan

20155

Virginia Cancer Specialists, PC, Gainesville

22031

Virginia Cancer Specialists, PC, Fairfax

22205

Virginia Cancer Specialists, PC, Arlington

22304

Virginia Cancer Specialists, PC, Alexandria

27710

Duke University Medical Center/Duke Cancer Center, Durham

29316

Prisma Health Cancer Institute, Boiling Springs

29605

Prisma Health Cancer Institute, Greenville

29615

Prisma Health Cancer Institute, Greenville

29640

Prisma Health Cancer Institute, Easley

29650

Prisma Health Cancer Institute, Greer

29672

Prisma Health Cancer Institute, Seneca

33612

Moffitt Cancer Center, Tampa

37066

Tennessee Oncology, PLLC, Gallatin

37075

Tennessee Oncology, PLLC, Hendersonville

37160

Tennessee Oncology, PLLC, Shelbyville

37203

Tennessee Oncology, PLLC, Nashville

43026

OSU Wexner Medical Center, Gynecologic Oncology at Mill Run, Hilliard

43035

OSU Wexner Medical Center, Outpatient Care Lewis Center, Lewis Center

43081

OSU Wexner Medical Center, Outpatient Care New Albany, Westerville

43203

OSU Wexner Medical Center, CarePoint East, Columbus

OSU Wexner Medical Center, Ohio State University Hospital East, Columbus

43210

OSU Wexner Medical Center, Arther G. James Cancer Hospital, and Solove Research Institute, Columbus

OSU Wexner Medical Center, Investigational Drug Services(IP Ship to), Columbus

Osu Wexner Medical Center, The Ohio State University Hospital, Columbus

43212

OSU Wexner Medical Center, Stefanie Spieman Comprehensive Breast Center, Columbus

43221

OSU Wexner Medical Center, Martha Morehouse Medical Plaza, Columbus

OSU Wexner Medical Center, OutPatient Care Upper Arlington, Columbus

43230

OSU Wexner Medical Center, CarePoint Gahanna, Gahanna

44106

University Hospitals Cleveland Medical Center, Cleveland

44122

UH Minoff Health Center at Chagrin Highlands, Orange

46010

Hospital Clínico Universitario de Valencia. Fundación Investigación Clínico de Valencia., Valencia

46015

Ascires Eresa Campanar, Valencia

Hospital Vithas Valencia 9 de Octubre, Valencia

53715

1 S Park St Medical Center, Madison

53792

University of Wisconsin Clinical Science Center, Madison

55426

Metro Minnesota Community Oncology Research Consortium (MMCORC), Saint Louis Park

55433

Minnesota Oncology Hematology, PA, Coon Rapids

63108

Washington University School of Medicine - Obstetrics & Gynecology [Academic Offices), St Louis

63110

Barnes-Jewish Hospital Investigational Drug Pharmacy (IDS), St Louis

Washington University School of Medicine - Obstetrics & Gynecology, St Louis

Washington University School of Medicine [Patient Clinics], St Louis

68114

Oncology Hematology West P.C. dba Nebraska Cancer Specialists, Omaha

68130

Oncology Hematology West P.C. dba Nebraska Cancer Specialists, Omaha

75063

US Oncology Investigational Product Center (IPC), Irving

US Oncology Investigational Products Center (IPC), Irving

US Oncology lnvestigational Products Center (IPC), Irving

76712

Texas Oncology - Central South, Waco

79606

Texas oncology-West Texas, Abilene

80012

Rocky Mountain Cancer Centers, Aurora

80260

Rocky Mountain Cancer Centers, Thornton

80303

Rocky Mountain Cancer Centers, Boulder

84112

Huntsman Cancer Institute, University of Utah, Salt Lake City

85016

HonorHealth, Phoenix

85284

HonorHealth, Tempe

85719

The University of Arizona Cancer Center-North Campus, Tucson

90505

City of Hope Torrance, Torrance

90808

City of Hope at Long Beach Worsham, Long Beach

90813

City of Hope at Long Beach Elm, Long Beach

92037

Koman Family Outpatient Pavilion, La Jolla

UC San Diego Medical Center - La Jolla (Jacobs Medical Center / Thornton Pavilion), La Jolla

UC San Diego Moores Cancer Center- Investigational Drug Services, La Jolla

UC San Diego Moores Cancer Center, La Jolla

92618

City of Hope at Irvine Sand Canyon, Irvine

92648

City of Hope at Huntington Beach, Huntington Beach

92663

City of Hope at Newport Beach Lido, Newport Beach

97213

Northwest Cancer Specialists, P.C., Portland

97223

Northwest Cancer Specialists, P.C., Tigard

97227

Northwest Cancer Specialists, P.C., Portland

98109

Fred Hutchinson Cancer Center, Seattle

98195

University of Washington Medical Center, Seattle

98684

Northwest Cancer Specialists, P.C., Vancouver

B- 6060

Grand Hopital de Charleroi, Charleroi

464-8681

Aichi Cancer Center Hospital, Nagoya

277-8577

National Cancer Center Hospital East, Kashiwa-shi

216-8511

St. Marianna University School of Medicine Hospital, Kawasaki

589-8511

Kindai University Hospital, Osakasayama-shi

104-0045

National Cancer Center Hospital, Cho-ku

135-8550

The Cancer Institute Hospital of JFCR, Tokyo

03722

Severance Hospital Yonsei University Health System, Seoul

03080

Seoul National University Hospital, Seoul

06351

Samsung Medical Center, Seoul

08029

Cetir Centre Medic, Barcelona

W1G 6AD

Sarah Cannon Research Institute UK, London

W1G 7AF

Diagnostic Centre, London

SM2 5PT

The Royal Marsden NHS Foundation Trust, Sutton

SE1 9RT

Guy's Hospital, London

Jonathan Poon, London

SW3 6JJ

The Royal Marsden NHS Foundation Trust, London

W1G 8BJ

The Harley Street Clinic, London

W1G 8PP

Radiology, London

All Listed Sponsors
lead

Seagen, a wholly owned subsidiary of Pfizer

INDUSTRY

NCT04579380 - Basket Study of Tucatinib and Trastuzumab in Solid Tumors With HER2 Alterations | Biotech Hunter | Biotech Hunter