602
Participants
Start Date
September 30, 2011
Primary Completion Date
February 28, 2013
Study Completion Date
August 31, 2015
Trastuzumab emtansine
The dose was calculated based on the patient's Baseline weight on Day 1 of each 3-week treatment cycle. The same dose was administered in subsequent cycles if the patient's weight stayed within 10% of the Baseline weight. If there was a weight change \> 10%, the dose was adjusted accordingly and the recorded weight became the new Baseline weight. Trastuzumab emtansine was provided as a single-use lyophilized formulation.
Treatment of physician's choice
"The treatment of physician's choice (TPC) was a protocol-specified approved or standard of care therapy or combination of therapies, based on frequently used regimens for late-line HER2-positive metastatic breast cancer treatment after receipt of both trastuzumab- and lapatinib-containing regimens. The therapies included single-agent chemotherapy, single-agent (e.g., tamoxifen or aromatase inhibitor) or dual-agent (e.g., aromatase inhibitor with luteinizing hormone releasing hormone \[LHRH\] agonist) hormonal therapy for hormone receptor positive-disease, and HER2-directed therapy.~Participants who had documented progressive disease (PD) were eligible to switch treatment to receive trastuzumab emtansine 3.6 mg/kg. Participants who switched treatment remained on trastuzumab emtansine treatment until another PD event or unmanageable toxicity.~The formulation, storage, and preparation of all TPC were as per the appropriate package insert or national prescribing information."
Budapest
Budapest
Kogarah
Wilrijk
Leuven
Bern
Frankston
Miskolc
South Brisbane
Szolnok
Gyula
Perth
Kecskemét
Szeged
Zurich
Bangkok
Bangkok
The Bronx
Bangkok
Lake Success
Biella
Caen
A Coruña
Genoa
Philadelphia
Newark
Washington D.C.
Milan
Milan
Hamburg
Bethesda
Columbia
Hamburg
Richmond
Kiel
Bergamo
Brescia
Madrid
Madrid
Madrid
Charlotte
Málaga
Charleston
Murcia
Marietta
Hanover
Nîmes
Toulouse
Toulouse
Jacksonville
Coral Springs
Bordeaux
Plantation
Deerfield Beach
Bielefeld
Fort Myers
Montpellier
Tours
Nashville
Nashville
Chattanooga
Seville
Saint-Priest-en-Jarez
Columbus
Cona (Ferrara)
Nantes
Recklinghausen
Valencia
Fort Wayne
Bilbao
Detroit
Petah Tikva
Angers
Reims
Sioux City
Ramat Gan
Troisdorf
Trier
Mainz
Minneapolis
Maywood
Chicago
Chicago
St Louis
Strasbourg
Omaha
Lyon
Stuttgart
Hot Springs
Uppsala
Paris
Dallas
Rouen
Fort Worth
San Antonio
Napoli
Denver
München
Post Falls
Potenza
Tucson
Ravensburg
West Hollywood
Umeå
Jerusalem
San Diego
Highland
South San Francisco
San Francisco
Hayward
Vallejo
Walnut Creek
Oakland
Villejuif
Santa Clara
San Jose
Stockton
Roseville
Sacramento
Portland
Seattle
New Delhi
Moscow
Stavropol
Pune
Samara
Bangalore
Chennai
Kolkata
Hafia
Tel Aviv
Rehovot
Beersheba
Trumbull
Wichita
Scarborough
Boston
Boston
Boston
New Brunswick
Salvador
Goiânia
Rio de Janeiro
Porto Alegre
Itajaí
São Paulo
Moncton
Toronto
Québec
Regina
Saskatoon
Brno
Hradec Králové
Olomouc
Prague
Prague
Nice
Pune
Oslo
Bialystok
Bydgoszcz
Gdansk
Lublin
Poznan
Warsaw
Košice
Poprad
Kyunggi-do
Seoul
Seoul
Seoul
Seoul
Barcelona
Barcelona
Örebro
Brighton
Guildford
London
Maidstone
Metropolitan Borough of Wirral
Nottingham
Sheffield
Stoke-on-Trent
Westcliffe-on-sea
Hoffmann-La Roche
INDUSTRY