Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Breast Neoplasms

Breast Diseases

Skin Diseases

Antineoplastic Agents

All Drugs and Chemicals

Trastuzumab

Pertuzumab

Tucatinib

Antineoplastic Agents, Immunological

Protein Kinase Inhibitors

Enzyme Inhibitors

300mg given by mouth (orally) twice daily

6mg/kg given into the vein (IV; intravenously) or 600mg injected under the skin (SC; subcutaneous) every 21 days

600 mg pertuzumab, 600 mg trastuzumab, and 20,000 units hyaluronidase will be given by subcutaneous injection every 21 days. May be given in place of trastuzumab and pertuzumab individually.

Combination product: Trastuzumab + Pertuzumab

Placebo

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Lida Mina

Issam Makhoul

Molly Klipfel

Kay Yeung

Nicholas P McAndrew

Charity Huang

Pooja Advani

Carlos Alemany

Ana Fernandez

Jane L Meisel

Oana Danciu

Laila Agrawal

Alexandra Cline

David Riseberg

Pyone Lei Lei Mon

Ciara O'Sullivan

Timothy J Pluard

Margaret Block

Mridula George

Sun Young Oh

Halle C Moore, MD

Erika P Hamilton

Natasha Hunter

Yee Chung Cheng

Meena Okera

Sina Vatandoust

Susan Chua

Jane Beith

Shane White

Dhanusha Sabanathan

Daphne Tsoi

Nicholas Wilcken

Edgar Petru

Daniel Egle

Andreas Reichinger

Michael Hubalek

Christian Singer

Michail Ignatiadis

Francois Pierre Duhoux

Christel Fontaine

Renaud Poncin

Luc Dirix

Carlos Eduardo Paiva, MD

Roberto Hegg

Eduardo Henrique Cronemberger Costa e Silva

Ruffo de Freitas Junior

Patricia Medeiros Milhomem Beato

Vitor Liutti

Luciana Carla Aquino Pimentel, MD

Katsuki Arima Tiscoski, MD

Pedro Emanuel Rubini Liedke

Christina Pimentel Oppermann

Jose Luiz Pedrini

Patricia Santi

Joao Daniel Cardoso Guedes

Marcelle Cesca

Felipe Jose Silva Melo Cruz

Vanessa Petry Helena

Sanraj Basi

Susan Ellard

Marie-France Savard

Katarzyna Jerzak

Christine Brezden-Masley

Jose Luiz Guimaraes, MD

Jean-Pierre Ayoub

Cristiano Ferrario

Carlos Gallardo Araneda

Cesar Sanchez

Hernan Araya Moya

Eduardo Yanez Ruiz

Alejandro Acevedo Gaete

Zang Aimin

Zhang Yongqiang

Wei Li

Chunhong Hu

Liao Ning

Wu Jinsheng

Xiaojia Wang

Jian Huang

Wang Xian

Medical Monitor

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.

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.

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

A Randomized, Double-blind, Phase 3 Study of Tucatinib or Placebo in Combination With Trastuzumab and Pertuzumab as Maintenance Therapy for Metastatic HER2+ Breast Cancer (HER2CLIMB-05)

The time from the date of randomization to the investigator assessment of disease progression according to RECIST v1.1 or death from any cause

The time from randomization to death from any cause.

The time from the date of randomization to the documented disease progression assessed by BICR according to RECIST v1.1 or death from any cause

Will be measured based on patient reported outcomes (PROs) according to the European Organization for Research and Treatment of Cancer quality of life questionnaire (EORTC QLQ C30).

The time from randomization to investigator assessed disease progression in brain (RECIST v1.1), or death from any cause

Any untoward medical occurrence in a clinical investigational participant administered a medicinal product and which does not necessarily have a causal relationship with this treatment.

To be summarized using descriptive statistics.

Merck Sharp & Dohme LLC

Seagen Inc.

Spots Global Cancer Trial Database for combination product: trastuzumab + pertuzumab