Breast Cancer Clinical Trial

A Study of Tucatinib or Placebo With Trastuzumab and Pertuzumab for Metastatic HER2+ Breast Cancer

Summary

This study is being done to see if tucatinib works better than placebo when given with other drugs to treat participants with HER2-positive breast cancer. A placebo is a pill that looks the same as tucatinib but has no medicine in it. This study will also test what side effects happen when participants take this combination of drugs. A side effect is anything a drug does to the body besides treating your disease.

Participants will have cancer that has spread in the body near where it started (locally advanced) and cannot be removed (unresectable) or has spread through the body (metastatic).

In this study, all participants will get either tucatinib or placebo. Participants will be assigned randomly to a group. This is a blinded study, so patients and their doctors will not know which group a participant is in.

All participants will also get trastuzumab and pertuzumab. These are 2 drugs used to treat this type of cancer.

View Full Description

Full Description

Control arm: Placebo given orally twice daily plus trastuzumab and pertuzumab every 21 days

Experimental arm: Tucatinib 300 mg given orally twice daily plus trastuzumab and pertuzumab every 21 days

Trastuzumab and pertuzumab will be administered as follows:

• Trastuzumab will be given intravenously (IV) at a dose of 6 mg/kg or subcutaneously (SC) at a fixed dose of 600 mg, once every 21 days.

AND

Pertuzumab will be given IV at 420 mg every 21 days. OR
Fixed dose combination of 600 mg pertuzumab, 600 mg trastuzumab, and 20,000 units hyaluronidase will be given SC, once every 21 days, in lieu of trastuzumab and pertuzumab individually.

View Eligibility Criteria

Eligibility Criteria

Inclusion Criteria:

Centrally confirmed HER2+ breast carcinoma per 2018 American Society of Clinical Oncologists (ASCO) College of American Pathologists (CAP) guidelines.

Have unresectable locally advanced or metastatic disease.

If recurrent (after [neo]adjuvant therapy), must be at least 6 month treatment free from any trastuzumab or pertuzumab received for advanced HER2+ disease.
Have received 4-8 cycles (21 day cycles) of previous treatment with trastuzumab, pertuzumab, and taxane as first-line therapy for advanced HER2+ breast cancer with no evidence of disease progression
Known hormone receptor status (per local guidelines; may be hormone receptor positive [HR+] or negative [HR-])
Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1

CNS Inclusion - Based on screening contrast brain magnetic resonance imaging (MRI), participants may have any of the following:

No evidence of brain metastases
Untreated brain metastases which are asymptomatic and, if identified on prior brain imaging, without evidence of progression since starting first-line induction therapy with trastuzumab, pertuzumab, and taxane

Previously treated brain metastases which are asymptomatic

Brain metastases previously treated with local therapy must not have progressed since treatment

Exclusion Criteria:

Prior treatment with any anti-HER2 and/or anti-epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor including pyrotinib, lapatinib, tucatinib, neratinib, and afatinib (except neratinib if given in extended adjuvant setting and ≥ 12 months have elapsed since last neratinib dose prior to start of study drug)
Unable to undergo contrast MRI of the brain

CNS Exclusion - Based on screening brain MRI and clinical assessment

Symptomatic brain metastasis
Progression of brain metastases since starting first line trastuzumab, pertuzumab, and taxane
Ongoing use of systemic corticosteroids at a total daily dose of >2 mg of dexamethasone (or equivalent)
Any untreated brain lesion in an anatomic site which may pose risk to participant
Known or suspected leptomeningeal disease (LMD)
Poorly controlled (>1/week) seizures, or other persistent neurologic symptoms

Study is for people with:

Breast Cancer

Phase:

Phase 3

Estimated Enrollment:

650

Study ID:

NCT05132582

Recruitment Status:

Recruiting

Sponsor:

Seagen Inc.

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There are 100 Locations for this study

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Mayo Clinic Arizona
Phoenix Arizona, 85054, United States More Info
Mayo Clinic Arizona Clinical Trials Referral Office Inbox
Contact
855-776-0015
Lida Mina
Principal Investigator
UCLA Medical Center / David Geffen School of Medicine
Santa Monica California, 90404, United States More Info
Nicholas McAndrew
Contact
310-980-6537
[email protected]
Nicholas McAndrew
Principal Investigator
Mayo Clinic Florida
Jacksonville Florida, 32224, United States More Info
Pooja Advani
Contact
904-953-0707
[email protected]
Pooja Advani
Principal Investigator
AdventHealth Cancer Institute
Orlando Florida, 32804, United States More Info
Carlos Alemany
Contact
407-303-2024
[email protected]
Carlos Alemany
Principal Investigator
Orlando Health, Inc. TRIO
Orlando Florida, 32806, United States More Info
Ana Fernandez
Contact
321-841-8557
[email protected]
Ana Fernandez
Principal Investigator
Winship Cancer Institute / Emory University School of Medicine
Atlanta Georgia, 30322, United States More Info
Jane Meisel
Principal Investigator
Kaiser Permanente Moanalua Medical Center
Honolulu Hawaii, 96819, United States More Info
Jennifer Carney
Contact
202-432-0000
[email protected]
Jennifer Carney
Principal Investigator
University of Illinois at Chicago
Chicago Illinois, 60612, United States More Info
Oana Danciu
Contact
312-996-1581
[email protected]
Oana Danciu
Principal Investigator
Norton Cancer Institute
Louisville Kentucky, 40202, United States More Info
Laila Agrawal
Principal Investigator
Norton Cancer Institute
Louisville Kentucky, 40207, United States More Info
Laila Agrawal
Principal Investigator
Norton Cancer Institute
Louisville Kentucky, 40241, United States More Info
Laila Agrawal
Contact
502-394-6350
[email protected]
Laila Agrawal
Principal Investigator
Mercy Medical Center -Weinberg Center
Baltimore Maryland, 21202, United States More Info
Alexandra Cline
Contact
410-951-7956
[email protected]
David Riseberg
Principal Investigator
Mayo Clinic Rochester
Rochester Minnesota, 55905, United States More Info
Jackie Chonis
Contact
507-284-1887
[email protected]
Ciara O'Sullivan
Principal Investigator
Saint Luke's Cancer Institute LLC
Kansas City Missouri, 64113, United States More Info
Timothy Pluard
Contact
816-932-6005
[email protected]
Timothy Pluard
Principal Investigator
Nebraska Cancer Specialists
Grand Island Nebraska, 68803, United States More Info
Margaret Block
Principal Investigator
Oncology Hematology West, P.C.
Omaha Nebraska, 68130, United States More Info
Margaret Block
Contact
402-334-4773
[email protected]
Margaret Block
Principal Investigator
Rutgers Cancer Institute of New Jersey
Jersey City New Jersey, 07302, United States More Info
Mridula George
Principal Investigator
Monmouth Medical Center Southern Campus
Lakewood New Jersey, 08701, United States More Info
Mridula George
Principal Investigator
Saint Barnabas Medical Center Cancer Center
Livingston New Jersey, 07039, United States More Info
Mridula George
Principal Investigator
Monmouth Medical Center
Long Branch New Jersey, 07740, United States More Info
Mridula George
Principal Investigator
Rutgers Cancer Institute of New Jersey
New Brunswick New Jersey, 08903, United States More Info
Mridula George
Contact
732-235-2465
[email protected]
Mridula George
Principal Investigator
Robert Wood Johnson University Hospital Somerset
Somerville New Jersey, 08876, United States More Info
Mridula George
Principal Investigator
Community Medical Center
Toms River New Jersey, 08755, United States More Info
Mridula George
Principal Investigator
Montefiore Medical Center
Bronx New York, 10461, United States More Info
Sun Young Oh
Contact
718-405-8404
[email protected]
Sun Young Oh
Principal Investigator
Cleveland Clinic Lerner College of Medicine
Cleveland Ohio, 44195, United States More Info
Halle Moore
Contact
216-445-4624
[email protected]
Halle Moore, MD
Principal Investigator
Zangmeister Cancer Center
Columbus Ohio, 43219, United States More Info
Jeanna Knoble
Contact
614-383-6000
[email protected]
Jeanna Knoble
Principal Investigator
Thomas Jefferson University
Philadelphia Pennsylvania, 19107, United States More Info
Maysa Abu Khalaf
Contact
203-785-4095
[email protected]
Maysa Abu Khalaf
Principal Investigator
Thomas Jefferson University
Philadelphia Pennsylvania, 19114, United States More Info
Maysa Abu Khalaf
Principal Investigator
Thomas Jefferson University
Willow Grove Pennsylvania, 19090, United States More Info
Maysa Abu Khalaf
Principal Investigator
Charleston Oncology
Charleston South Carolina, 29414, United States More Info
David Ellison
Contact
843-958-2666
[email protected]
David Ellison
Principal Investigator
Tennessee Oncology-Nashville/Sarah Cannon Research Institute
Nashville Tennessee, 37203, United States More Info
Erika Hamilton
Contact
615-329-7274
[email protected]
Erika Hamilton
Principal Investigator
Seattle Cancer Care Alliance / University of Washington
Seattle Washington, 98109, United States More Info
Natasha Hunter
Contact
206-288-7222
[email protected]
Natasha Hunter
Principal Investigator
Medical College of Wisconsin (Milwaukee)
Milwaukee Wisconsin, 53226, United States More Info
Sailaja Kamaraju
Contact
414-975-6889
[email protected]
Sailaja Kamaraju
Principal Investigator
Box Hill Hospital
Box Hill Other, 3128, Australia More Info
Susan Chua
Principal Investigator
Chris O'Brien Lifehouse
Camperdown Other, 2050, Australia More Info
Jane Beith
Principal Investigator
Peninsula and South East Oncology
Frankston Other, 3199, Australia More Info
Vinod Ganju
Principal Investigator
Austin Health
Heidelberg Other, 3084, Australia More Info
Shane White
Principal Investigator
Macquarie University Hospital
Macquarie University Other, 2109, Australia More Info
Dhanusha Sabanathan
Principal Investigator
Westmead Hospital
Sydney Other, 2145, Australia More Info
Rina Hui
Principal Investigator
Clinique Saint Pierre
Ottignies Other, 1340, Belgium More Info
Renaud Poncin
Principal Investigator
GZA Hospital Sint-Augustinus
Wilrijk Other, 2610, Belgium More Info
Luc Dirix
Principal Investigator
Clinica de Pesquisas e Centro de Estudos em Oncologia Ginecologica e Mamaria Ltda.
Bela Vista Other, 01317, Brazil More Info
Roberto Hegg
Principal Investigator
Centro Regional Integrado de Oncologia
Fortaleza Other, 60336, Brazil More Info
Eduardo Henrique Cronemberger Costa e Silva
Principal Investigator
Hospital Araujo Jorge - Associacao de Combate ao Cancer em Goias
Goiania Other, 74605, Brazil More Info
Ruffo de Freitas Junior
Principal Investigator
Fundação Doutor Amaral Carvalho
Jaú Other, 17210, Brazil More Info
Patricia Medeiros Milhomem Beato
Principal Investigator
Hospital do Cancer de Londrina
Londrina Other, 86015, Brazil More Info
Vitor Liutti
Principal Investigator
Hospital de Clinicas de Porto Alegre
Porto Alegre Other, 90035, Brazil More Info
Pedro Emanuel Rubini Liedke
Principal Investigator
Centro Gaucho Integrado de Oncologia, Hematologia, Ensino e Pesquisa
Porto Alegre Other, 90110, Brazil More Info
Christina Pimentel Oppermann
Principal Investigator
Sao Camilo Oncologia
Sao Paulo Other, 04014, Brazil More Info
Felipe Jose Silva Melo Cruz
Principal Investigator
Fundação NAtonio Prudente (AC Camargo Cancer Center)
Sao Paulo , 01509, Brazil More Info
Marcelle Cesca
Principal Investigator
University of Alberta / Cross Cancer Institute
Edmonton Alberta, T6G 1, Canada More Info
Sanraj Basi
Principal Investigator
BC Cancer Kelowna
Kelowna British Columbia, V1Y5L, Canada More Info
Susan Ellard
Principal Investigator
Ottawa Hospital Cancer Centre
Ottawa Ontario, K1H 8, Canada More Info
Marie-France Savard
Principal Investigator
Sunnybrook Odette Cancer Centre
Toronto Ontario, M4N3M, Canada More Info
Katarzyna Jerzak
Principal Investigator
Beijing Hospital
Beijing Other, 10073, China More Info
Yong Qiang Zhang
Principal Investigator
The first Affiliated Hospital of Hainan Medical University
Haikou Other, 57010, China More Info
Wu Jinsheng
Principal Investigator
The Second Affiliated Hospital of Zhejiang University School of Medicine
Hangzhou Other, 31000, China More Info
Jian Huang
Principal Investigator
The Second Hospital of Anhui Medical University
Hefei Other, 23060, China More Info
Fanfan Li
Principal Investigator
Liuzhou People's Hospital
Liuzhou Other, 54500, China More Info
Minmin Zhang
Principal Investigator
The Second Affiliated Hospital of Nanchang University
Nanchang Other, 33000, China More Info
Luo Yonghui
Principal Investigator
Hubei Cancer Hospital
Wuhan Other, 43000, China More Info
Xinhong Wu
Principal Investigator
The First Affiliated Hospital of Xi'an Jiaotong University
Xi'an Other, 71006, China More Info
Jin Yang
Principal Investigator
Shaanxi Provincial People's Hospital
Xi'an Other, 71006, China More Info
Song Zhangjun
Principal Investigator
Sainte Catherine Institut du Cancer Avignon Provence
Avignon Other, 84000, France More Info
Julien Grenier
Principal Investigator
Centre Hospitalier Regional et Universitaire de Besancon - Hopital Jean-Minjoz
Besancon Cedex Other, 25000, France More Info
Fernando Bazan
Principal Investigator
Centre Leon Berard - Centre regional de lutte contre le cancer Rhone-Alpes
Lyon Other, 69008, France More Info
Thomas Bachelot
Principal Investigator
Centre de Cancerologie du Grand Montpellier
Montpellier Other, 34070, France More Info
Cristian Villanueva
Principal Investigator
Hopitaux Civils de Lyon
Pierre Benite Other, 69310, France More Info
Nathalie Bonnin
Principal Investigator
Centre Eugene Marquis
Rennes Other, 35042, France More Info
Veronique Dieras
Principal Investigator
Institut de Cancerologie de lOuest - Site Rene Gauducheau
Saint Herblain cedex Other, 44800, France More Info
Jean Sebastien Frenel
Principal Investigator
Institut de cancerologie Strasbourg Europe
Strasbourg Other, 67033, France More Info
Thierry Petit
Principal Investigator
St. Elisabeth-Krankenhaus Koln-Hohenlind
Koln Other, 50935, Germany More Info
Johannes Holtschmidt
Principal Investigator
National Hospital Organization Kyushu Cancer Center
Fukuoka-shi Other, 811-1, Japan More Info
Eriko Tokunaga
Principal Investigator
Fukushima Medical University Hospital
Fukushima-shi Other, 960-1, Japan More Info
Shigehira Saji
Principal Investigator
Shikoku Cancer Center
Matsuyama Other, 791-0, Japan More Info
Kenjiro Aogi
Principal Investigator
National Hospital Organization Hokkaido Cancer Center
Sapporo-shi Other, 003-0, Japan More Info
Hideki Maeda
Principal Investigator
Showa University Hospital
Shinagawa-ku Other, 142-8, Japan More Info
Junji Tsurutani
Principal Investigator
Kanagawa Cancer Center
Yokohama Other, 241-8, Japan More Info
Toshinari Yamashita
Principal Investigator
Chungbuk National University Hospital
Cheongju-si Other, 28644, Korea, Republic of More Info
Yaewon Yang
Principal Investigator
Gachon University Gil Medical Center
Incheon Other, 21565, Korea, Republic of More Info
Hee Kyung Ahn
Principal Investigator
Seoul National University Bundang Hospital
Seongnam-si Other, 13620, Korea, Republic of More Info
Jee Hyun Kim
Principal Investigator
Seoul National University Hospital
Seoul Other, 03080, Korea, Republic of More Info
Kyung Hun Lee
Principal Investigator
Severance Hospital, Yonsei University Health System
Seoul Other, 03722, Korea, Republic of More Info
Joo Hyuk Sohn
Principal Investigator
Ewha Womans University Mokdong Hospital
Seoul Other, 07985, Korea, Republic of More Info
Kyoung Eun Lee
Principal Investigator
St. Vincent's Hospital, The Catholic University of Korea
Suwon-si Other, 16247, Korea, Republic of More Info
Byoung Yong Shim
Principal Investigator
Ajou University Hospital
Suwon-si Other, 16499, Korea, Republic of More Info
Seok Yun Kang
Principal Investigator
Severance Hospital, Yonsei University Health System
Wonju-si Other, 26426, Korea, Republic of More Info
Seungtaek Lim
Principal Investigator
Asan Medical Center
Seoul , 05505, Korea, Republic of More Info
Sung Bae Kim
Principal Investigator
Przychodnia Lekarska KOKMED Roman Karaszewski
Konin Other, 62-50, Poland More Info
Bogusława Karaszewska
Principal Investigator
Hospital General Universitario Alicante
Alicante Other, 03010, Spain More Info
Juan Jose Ponce Lorenzo
Principal Investigator
Hospital de la Santa Creu i Sant Pau
Barcelona Other, 08041, Spain More Info
Agusti Barnadas Molins
Principal Investigator
Hospital Clinico Universitario de Salamanca
Salamanca Other, 37007, Spain More Info
Cesar Rodriguez
Principal Investigator
Kantonsspital Baden AG
Baden Other, 5404, Switzerland More Info
Tilly Nothhelfer
Principal Investigator
Brust-Zentrum Zurich
Zurich Other, 8008, Switzerland More Info
Urs Breitenstein
Principal Investigator
Kaohsiung Medical University Hospital
Kaohsiung Other, 807, Taiwan More Info
Hou Ming-Feng
Principal Investigator
Central Hospital of the Ministry of National Defense
Taipei Other, 11490, Taiwan More Info
Dai Ming-Shen
Principal Investigator
National Taiwan University Hospital
Taipei , 10002, Taiwan More Info
Chiun-Sheng Huang
Principal Investigator
University College London Hospitals NHS Foundation Trust
London Other, NW1 2, United Kingdom More Info
Rebecca Roylance
Principal Investigator
The Royal Marsden NHS Foundation Trust (RM)
London Other, SW3 6, United Kingdom More Info
Alicia Okines
Principal Investigator
Christie Hospital NHS Foundation Trust
Manchester Other, M20 4, United Kingdom More Info
Anne Armstrong
Principal Investigator
The Royal Marsden NHS Foundation Trust (RM)
Sutton Other, SM2 5, United Kingdom More Info
Alicia Okines
Principal Investigator

How clear is this clinincal trial information?

Study is for people with:

Breast Cancer

Phase:

Phase 3

Estimated Enrollment:

650

Study ID:

NCT05132582

Recruitment Status:

Recruiting

Sponsor:


Seagen Inc.

How clear is this clinincal trial information?

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