A Study of Trastuzumab Emtansine in Comparison With Treatment of Physician's Choice in Participants With HER2-positive Breast Cancer Who Have Received at Least Two Prior Regimens of HER2-directed Therapy
NCT ID: NCT01419197
Last Updated: 2016-10-12
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
602 participants
INTERVENTIONAL
2011-09-30
2015-08-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Trastuzumab emtansine
Trastuzumab emtansine 3.6 mg/kg intravenously every 3 weeks until disease progression (as assessed by the investigator) or unmanageable toxicity.
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
Treatment of physician's choice until disease progression (as assessed by the investigator) or unmanageable toxicity. The treatments included single-agent chemotherapy, single-agent or dual-agent hormonal therapy for hormone receptor positive-disease, and HER2-directed therapy.
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.
Interventions
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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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Histologically or cytologically documented breast cancer.
* Metastatic or unresectable locally advanced/recurrent breast cancer.
* HER2-positive disease by prospective laboratory confirmation.
* Disease progression on the last regimen received as defined by the investigator.
* Prior treatment with an trastuzumab, a taxane, and lapatinib.
* Disease progression after at least two regimens of HER2-directed therapy in the metastatic or unresectable locally advanced/recurrent setting.
* Adequate organ function, as evidenced by laboratory results.
* Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2.
* Left ventricular ejection fraction (LVEF) ≥ 50% by echocardiogram or multi gated acquisition scan.
Exclusion Criteria
* Trastuzumab ≤ 21 days before first study treatment.
* Lapatinib ≤ 14 days before first study treatment.
* Prior enrollment in a trastuzumab emtansine containing study, regardless whether the patient received prior trastuzumab emtansine.
* Brain metastases that are untreated or symptomatic, or require any radiation, surgery or corticosteroid therapy to control symptoms within 1 month of randomization.
18 Years
ALL
No
Sponsors
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Hoffmann-La Roche
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Trials
Role: STUDY_DIRECTOR
Hoffmann-La Roche
Locations
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Tucson, Arizona, United States
Hot Springs, Arkansas, United States
Hayward, California, United States
Highland, California, United States
Oakland, California, United States
Roseville, California, United States
Sacramento, California, United States
San Diego, California, United States
San Francisco, California, United States
San Jose, California, United States
Santa Clara, California, United States
South San Francisco, California, United States
Stockton, California, United States
Vallejo, California, United States
Walnut Creek, California, United States
West Hollywood, California, United States
Denver, Colorado, United States
Trumbull, Connecticut, United States
Newark, Delaware, United States
Washington D.C., District of Columbia, United States
Coral Springs, Florida, United States
Deerfield Beach, Florida, United States
Fort Myers, Florida, United States
Jacksonville, Florida, United States
Plantation, Florida, United States
Marietta, Georgia, United States
Post Falls, Idaho, United States
Chicago, Illinois, United States
Chicago, Illinois, United States
Maywood, Illinois, United States
Fort Wayne, Indiana, United States
Sioux City, Iowa, United States
Wichita, Kansas, United States
Scarborough, Maine, United States
Bethesda, Maryland, United States
Columbia, Maryland, United States
Boston, Massachusetts, United States
Boston, Massachusetts, United States
Boston, Massachusetts, United States
Detroit, Michigan, United States
Minneapolis, Minnesota, United States
St Louis, Missouri, United States
Omaha, Nebraska, United States
New Brunswick, New Jersey, United States
Lake Success, New York, United States
The Bronx, New York, United States
Charlotte, North Carolina, United States
Columbus, Ohio, United States
Portland, Oregon, United States
Philadelphia, Pennsylvania, United States
Charleston, South Carolina, United States
Chattanooga, Tennessee, United States
Nashville, Tennessee, United States
Nashville, Tennessee, United States
Dallas, Texas, United States
Fort Worth, Texas, United States
San Antonio, Texas, United States
Richmond, Virginia, United States
Seattle, Washington, United States
Kogarah, New South Wales, Australia
South Brisbane, Queensland, Australia
Frankston, Victoria, Australia
Perth, Western Australia, Australia
Leuven, , Belgium
Wilrijk, , Belgium
Salvador, Estado de Bahia, Brazil
Goiânia, Goiás, Brazil
Rio de Janeiro, Rio de Janeiro, Brazil
Porto Alegre, Rio Grande do Sul, Brazil
Itajaí, Santa Catarina, Brazil
São Paulo, São Paulo, Brazil
Moncton, New Brunswick, Canada
Toronto, Ontario, Canada
Québec, Quebec, Canada
Regina, Saskatchewan, Canada
Saskatoon, Saskatchewan, Canada
Brno, , Czechia
Hradec Králové, , Czechia
Olomouc, , Czechia
Prague, , Czechia
Prague, , Czechia
Angers, , France
Bordeaux, , France
Caen, , France
Lyon, , France
Montpellier, , France
Nantes, , France
Nice, , France
Nîmes, , France
Paris, , France
Reims, , France
Rouen, , France
Saint-Priest-en-Jarez, , France
Strasbourg, , France
Toulouse, , France
Toulouse, , France
Tours, , France
Villejuif, , France
Bielefeld, , Germany
Hamburg, , Germany
Hamburg, , Germany
Hanover, , Germany
Kiel, , Germany
Mainz, , Germany
München, , Germany
Ravensburg, , Germany
Recklinghausen, , Germany
Stuttgart, , Germany
Trier, , Germany
Troisdorf, , Germany
Budapest, , Hungary
Budapest, , Hungary
Gyula, , Hungary
Kecskemét, , Hungary
Miskolc, , Hungary
Szeged, , Hungary
Szolnok, , Hungary
Bangalore, , India
Chennai, , India
Kolkata, , India
New Delhi, , India
Pune, , India
Pune, , India
Beersheba, , Israel
Hafia, , Israel
Jerusalem, , Israel
Petah Tikva, , Israel
Ramat Gan, , Israel
Rehovot, , Israel
Tel Aviv, , Israel
Potenza, Basilicate, Italy
Napoli, Campania, Italy
Genoa, Liguria, Italy
Bergamo, Lombardy, Italy
Brescia, Lombardy, Italy
Milan, Lombardy, Italy
Milan, Lombardy, Italy
Biella, Piedmont, Italy
Cona (Ferrara), Veneto, Italy
Oslo, , Norway
Bialystok, , Poland
Bydgoszcz, , Poland
Gdansk, , Poland
Lublin, , Poland
Poznan, , Poland
Warsaw, , Poland
Moscow, , Russia
Samara, , Russia
Stavropol, , Russia
Košice, , Slovakia
Poprad, , Slovakia
Kyunggi-do, , South Korea
Seoul, , South Korea
Seoul, , South Korea
Seoul, , South Korea
Seoul, , South Korea
Barcelona, Barcelona, Spain
Barcelona, Barcelona, Spain
A Coruña, La Coruña, Spain
Madrid, Madrid, Spain
Madrid, Madrid, Spain
Madrid, Madrid, Spain
Málaga, Malaga, Spain
Murcia, Murcia, Spain
Seville, Sevilla, Spain
Valencia, Valencia, Spain
Bilbao, Vizcaya, Spain
Örebro, , Sweden
Umeå, , Sweden
Uppsala, , Sweden
Bern, , Switzerland
Zurich, , Switzerland
Bangkok, , Thailand
Bangkok, , Thailand
Bangkok, , Thailand
Brighton, , United Kingdom
Guildford, , United Kingdom
London, , United Kingdom
Maidstone, , United Kingdom
Metropolitan Borough of Wirral, , United Kingdom
Nottingham, , United Kingdom
Sheffield, , United Kingdom
Stoke-on-Trent, , United Kingdom
Westcliffe-on-sea, , United Kingdom
Countries
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References
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Chen SC, Quartino A, Polhamus D, Riggs M, French J, Wang X, Vadhavkar S, Smitt M, Hoersch S, Strasak A, Jin JY, Girish S, Li C. Population pharmacokinetics and exposure-response of trastuzumab emtansine in advanced breast cancer previously treated with >/=2 HER2-targeted regimens. Br J Clin Pharmacol. 2017 Dec;83(12):2767-2777. doi: 10.1111/bcp.13381. Epub 2017 Sep 3.
Krop IE, Kim SB, Martin AG, LoRusso PM, Ferrero JM, Badovinac-Crnjevic T, Hoersch S, Smitt M, Wildiers H. Trastuzumab emtansine versus treatment of physician's choice in patients with previously treated HER2-positive metastatic breast cancer (TH3RESA): final overall survival results from a randomised open-label phase 3 trial. Lancet Oncol. 2017 Jun;18(6):743-754. doi: 10.1016/S1470-2045(17)30313-3. Epub 2017 May 16.
Krop IE, Kim SB, Gonzalez-Martin A, LoRusso PM, Ferrero JM, Smitt M, Yu R, Leung AC, Wildiers H; TH3RESA study collaborators. Trastuzumab emtansine versus treatment of physician's choice for pretreated HER2-positive advanced breast cancer (TH3RESA): a randomised, open-label, phase 3 trial. Lancet Oncol. 2014 Jun;15(7):689-99. doi: 10.1016/S1470-2045(14)70178-0. Epub 2014 May 2.
Other Identifiers
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BO25734
Identifier Type: OTHER
Identifier Source: secondary_id
2011-000509-29
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
TDM4997g
Identifier Type: -
Identifier Source: org_study_id
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