AzTrials
AzTrials

Breast CancerPhase 3EMILIANCT00829166

A Study of Trastuzumab Emtansine Versus Capecitabine + Lapatinib in Participants With HER2-positive Locally Advanced or Metastatic Breast Cancer

A Phase 3 study testing Trastuzumab emtansine, Lapatinib and Capecitabine in people with Breast Cancer, run by Hoffmann-La Roche at 323 sites in 27 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

This is a Phase III, randomized, multicenter, international, 2-arm, open-label clinical trial designed to compare the safety and efficacy of trastuzumab emtansine (T-DM1) with that of capecitabine + lapatinib in participants with human epidermal growth factor receptor 2 (HER2)-positive locally advanced or metastatic… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Breast Cancer
What is being tested?
Trastuzumab emtansine, Lapatinib and Capecitabine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
991 participants
Where
323 sitesin 27 countries
Study dates
Feb 2009to Sep 2015
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • HER2 status must be prospectively, centrally tested and be HER2-positive based on central laboratory assay results
  • Histologically or cytologically confirmed invasive breast cancer
  • Prior treatment for breast cancer in the adjuvant, unresectable, locally advanced, or metastatic setting must include both a taxane, alone or in combination with another agent, and trastuzumab, alone or in combination with another agent
  • Documented progression (which occur during or after most recent treatment or within 6 months after completing of adjuvant therapy) of incurable, unresectable, locally advanced or metastatic breast cancer, defined by the investigator
  • Measurable and/or nonmeasurable disease; participants with central nervous system-only disease are excluded
  • Cardiac ejection fraction greater than or equal to (>/=) 50 percent (%) by either echocardiogram or multi-gated acquisition scan
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
  • For women of childbearing potential and men with partners of childbearing potential, agreement to use a highly effective, non-hormonal form of contraception; contraception use should continue for the duration of the study treatment and for at least 6 months after the last dose of study treatment

Who cannot join

  • History of treatment with trastuzumab emtansine
  • Prior treatment with lapatinib or capecitabine
  • Peripheral neuropathy of Grade >/= 3 per National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE), Version 3.0
  • History of other malignancy within the last 5 years, except for appropriately treated carcinoma in situ of the cervix, non-melanoma skin carcinoma, Stage 1 uterine cancer, synchronous or previously diagnosed HER2-positive breast cancer, or cancers with a similar curative outcome as those mentioned above
  • History of receiving any anti-cancer drug/biologic or investigational treatment within 21 days prior to randomization except hormone therapy, which could be given up to 7 days prior to randomization; recovery of treatment-related toxicity consistent with other eligibility criteria
  • History of radiation therapy within 14 days of randomization
Show all 17Show fewer
  • Brain metastases that are untreated, symptomatic, or require therapy to control symptoms, as well as any history of radiation, surgery, or other therapy, including steroids, to control symptoms from brain metastases within 2 months (60 days) of randomization
  • History of symptomatic congestive heart failure or serious cardiac arrhythmia requiring treatment
  • History of myocardial infarction or unstable angina within 6 months of randomization
  • Current dyspnea at rest due to complications of advanced malignancy or current requirement for continuous oxygen therapy
  • Current severe, uncontrolled systemic disease (for example, clinically significant cardiovascular, pulmonary, or metabolic disease)
  • Pregnancy or lactation
  • Current known active infection with human immunodeficiency virus (HIV), hepatitis B virus, or hepatitis C virus
  • Presence of conditions that could affect gastrointestinal absorption: Malabsorption syndrome, resection of the small bowel or stomach, and ulcerative colitis
  • History of intolerance (such as Grade 3-4 infusion reaction) to trastuzumab
  • Known hypersensitivity to 5-fluorouracil or known dihydropyrimidine dehydrogenase deficiency
  • Current treatment with sorivudine or its chemically related analogs, such as brivudine

Trial locations and contacts

323 sites in 27 countries.

323 sites in 27 countries

United States177 sites

  • Study site

    Anaheim, California, 92801

  • Study site

    Anaheim, California, 92807

  • Study site

    Athens, Georgia, 30607

  • Study site

    Atlanta, Georgia, 30318

  • Study site

    Atlanta, Georgia, 30322

  • Study site

    Atlanta, Georgia, 30341

  • Study site

    Atlanta, Georgia, 30342

  • Study site

    Austin, Texas, 78731

  • Study site

    Bakersfield, California, 93309

  • Study site

    Baldwin Park, California, 91706

  • Study site

    Baltimore, Maryland, 21202

  • Study site

    Baltimore, Maryland, 21237

  • Study site

    Bellflower, California, 90706

  • Study site

    Bethesda, Maryland, 20817

  • Study site

    Bettendorf, Iowa, 52722

  • Study site

    Boca Raton, Florida, 33486

  • Study site

    Boise, Idaho, 83712

  • Study site

    Boston, Massachusetts, 02114

  • Study site

    Boston, Massachusetts, 02115

  • Study site

    Boston, Massachusetts, 02118

  • Study site

    Boston, Massachusetts, 02215

  • Study site

    Brockport, New York, 14420

  • Study site

    Brownstown, Michigan, 48183

  • Study site

    Bryan, Texas, 77802

  • Study site

    Burlington, Massachusetts, 01805

  • Study site

    Canandaigua, New York, 14424

  • Study site

    Carrolton, Georgia, 30117

  • Study site

    Cartersville, Georgia, 30121

  • Study site

    Chandler, Arizona, 85224

  • Study site

    Charlotte, North Carolina, 28203

  • Study site

    Cherry Hill, New Jersey, 08002

  • Study site

    Chicago, Illinois, 60612

  • Study site

    City of Saint Peters, Missouri, 63110

  • Study site

    City of Saint Peters, Missouri, 63376

  • Study site

    Cleveland, Ohio, 44106

  • Study site

    Cleveland, Ohio, 44195

  • Study site

    Columbia, South Carolina, 29210

  • Study site

    Columbus, Ohio, 43215

  • Study site

    Columbus, Ohio, 43219

  • Study site

    Columbus, Ohio, 43228

  • Study site

    Covington, Louisiana, 70433

  • Study site

    Cypress, Texas, 77429

  • Study site

    Dallas, Texas, 75230

  • Study site

    Dearborn, Michigan, 48126

  • Study site

    Decatur, Georgia, 30033

  • Study site

    Decatur, Illinois, 62526

  • Study site

    Detroit, Michigan, 48201

  • Study site

    Detroit, Michigan, 48202

  • Study site

    Douglasville, Georgia, 30134

  • Study site

    Duarte, California, 91010

  • Study site

    Durham, North Carolina, 27710

  • Study site

    East Providence, Rhode Island, 02915

  • Study site

    Edina, Minnesota, 55414

  • Study site

    Effingham, Illinois, 62526

  • Study site

    El Paso, Texas, 79902

  • Study site

    Fairfax, Virginia, 22031

  • Study site

    Fernandina Beach, Florida, 32034

  • Study site

    Fontana, California, 92335

  • Study site

    Fort Collins, Colorado, 80528

  • Study site

    Fort Lauderdale, Florida, 33316

  • Study site

    Fort Myers, Florida, 33916

  • Study site

    Fresh Meadows, New York, 11366

  • Study site

    Geneva, New York, 14456

  • Study site

    Gig Harbor, Washington, 98332

  • Study site

    Greece, New York, 14626

  • Study site

    Hackensack, New Jersey, 07601

  • Study site

    Hayward, California, 94545

  • Study site

    Henderson, Nevada, 89052

  • Study site

    Hickory, North Carolina, 28602

  • Study site

    Hollywood, Florida, 33021

  • Study site

    Houston, Texas, 77090

  • Study site

    Irvine, California, 92618

  • Study site

    Jacksonville, Florida, 32205

  • Study site

    Jacksonville, Florida, 32207

  • Study site

    Jacksonville, Florida, 32256

  • Study site

    Jacksonville, Florida, 32258

  • Study site

    Joliet, Illinois, 60435

  • Study site

    Joplin, Missouri, 64804

  • Study site

    Kansas City, Missouri, 64111

  • Study site

    Kinston, North Carolina, 28501

  • Study site

    Kissimmee, Florida, 34741

  • Study site

    Kittery, Maine, 03904

  • Study site

    La Jolla, California, 92093

  • Study site

    La Mesa, California, 91942

  • Study site

    Lafayette, Louisiana, 70503

  • Study site

    Lake Success, New York, 11042

  • Study site

    Lakeland, Florida, 33804-1057

  • Study site

    Lakewood, Washington, 98499

  • Study site

    Loma Linda, California, 92354

  • Study site

    Long Beach, California, 90806

  • Study site

    Los Angeles, California, 90025

  • Study site

    Los Angeles, California, 90034

  • Study site

    Los Angeles, California, 90057

  • Study site

    Los Angeles, California, 90095-1772

  • Study site

    Macon, Georgia, 31217

  • Study site

    Maplewood, Minnesota, 55109

  • Study site

    Marietta, Georgia, 30060

  • Study site

    Marrero, Louisiana, 70072

  • Study site

    Memphis, Tennessee, 38120

  • Study site

    Meridian, Idaho, 83642

  • Study site

    Metairie, Louisiana, 70006

  • Study site

    Miami, Florida, 33133

  • Study site

    Miami, Florida, 33136

  • Study site

    Miami, Florida, 33176

  • Study site

    Middletown, Ohio, 45042

  • Study site

    Milwaukee, Wisconsin, 53226

  • Study site

    Minneapolis, Minnesota, 55454

  • Study site

    Missoula, Montana, 59802

  • Study site

    Montebello, California, 90640

  • Study site

    Morris, Illinois, 60450

  • Study site

    Morristown, New Jersey, 07962

  • Study site

    Mount Kisco, New York, 10549

  • Study site

    Nampa, Idaho, 83686

  • Study site

    Nashville, Tennessee, 37203

  • Study site

    New Orleans, Louisiana, 70115

  • Study site

    Newark, Ohio, 43055

  • Study site

    Newport Beach, California, 92660

  • Study site

    North Charleston, South Carolina, 29425

  • Study site

    Norwalk, Connecticut, 06856

  • Study site

    Norwich, Connecticut, 06360

  • Study site

    Oakland, California, 94611

  • Study site

    Omaha, Nebraska, 68114

  • Study site

    Orange Park, Florida, 32073

  • Study site

    Paducah, Kentucky, 42001

  • Study site

    Panorama City, California, 91402

  • Study site

    Parsippany, New Jersey, 07054

  • Study site

    Peabody, Massachusetts, 01960

  • Study site

    Pembroke Pines, Florida, 33028

  • Study site

    Peoria, Illinois, 61615-7828

  • Study site

    Philadelphia, Pennsylvania, 19106

  • Study site

    Philadelphia, Pennsylvania, 19124

  • Study site

    Pittsburgh, Pennsylvania, 15213

  • Study site

    Pittsburgh, Pennsylvania, 15232

  • Study site

    Portland, Oregon, 97227

  • Study site

    Post Falls, Idaho, 83854

  • Study site

    Puyallup, Washington, 98372

  • Study site

    Riverside, California, 92505

  • Study site

    Rochester, New York, 14626

  • Study site

    Rockville, Maryland, 20850

  • Study site

    Roseville, California, 95661

  • Study site

    Sacramento, California, 95825

  • Study site

    Saint Joseph, Michigan, 49085

  • Study site

    Saint Louis Park, Minnesota, 55426

  • Study site

    Saint Paul, Minnesota, 55101

  • Study site

    San Diego, California, 92120

  • Study site

    San Diego, California, 92123

  • Study site

    San Francisco, California, 94115

  • Study site

    San Jose, California, 95119

  • Study site

    Sandusky, Ohio, 44870

  • Study site

    Santa Clara, California, 95051

  • Study site

    Santa Fe, New Mexico, 87505

  • Study site

    Santa Maria, California, 93454

  • Study site

    Santa Monica, California, 90404

  • Study site

    Shenandoah, Texas, 77384

  • Study site

    Skokie, Illinois, 60076

  • Study site

    South San Francisco, California, 94080

  • Study site

    St Louis, Missouri, 63110

  • Study site

    St Louis, Missouri, 63141

  • Study site

    Stamford, Connecticut, 06902

  • Study site

    Stony Brook, New York, 11794

  • Study site

    Tacoma, Washington, 98405

  • Study site

    Temple, Texas, 76501

  • Study site

    Thousand Oaks, California, 91360

  • Study site

    Tucson, Arizona, 85719

  • Study site

    Twin Falls, Idaho, 83301

  • Study site

    Vallejo, California, 94589

  • Study site

    Voorhees Township, New Jersey, 08043

  • Study site

    Walnut Creek, California, 94596

  • Study site

    Washington, North Carolina, 27889

  • Study site

    Washington D.C., District of Columbia, 20010

  • Study site

    Wausau, Wisconsin, 54401

  • Study site

    Wells, Maine, 04090

  • Study site

    West Bloomfield, Michigan, 48322

  • Study site

    Wichita, Kansas, 67214-3728

  • Study site

    Woodland Hills, California, 91367

  • Study site

    York Village, Maine, 03909

  • Study site

    Zion, Illinois, 60099

Other trials in United States

Brazil15 sites

  • Study site

    Belo Horizonte, 30150-281

  • Study site

    Curitiba, 80530-010

  • Study site

    Goiânia, 74605-070

  • Study site

    Itajaí, 88301-220

  • Study site

    Jaú, 17210-080

  • Study site

    João Pessoa, 58040280

  • Study site

    Porto Alegre, 90430-090

  • Study site

    Porto Alegre, 90610-000

  • Study site

    Porto Alegre, 91350-200

  • Study site

    Porto Alegre - Rs, 90050-170

  • Study site

    Rio de Janeiro, 20560-120

  • Study site

    Rio de Janeiro, 22260-020

  • Study site

    Santo André, 09060-870

  • Study site

    São Paulo, 01317-000

  • Study site

    São Paulo, 1323020

Other trials in Brazil

Italy15 sites

  • Study site

    Aviano, 33081

  • Study site

    Bologna, 40138

  • Study site

    Candiolo, 10060

  • Study site

    Genova, 16132

  • Study site

    Meldola, 47014

  • Study site

    Milan, 20133

  • Study site

    Milan, 20141

  • Study site

    Naples, 80131

  • Study site

    Negrar, 37024

  • Study site

    Pisa, 56100

  • Study site

    Reggio Emilia, 42100

  • Study site

    Roma, 00168

  • Study site

    Rozzano, 20089

  • Study site

    Sassari, 07100

  • Study site

    Terni, 05100

Other trials in Italy

Germany13 sites

  • Study site

    Aschaffenburg, 63739

  • Study site

    Berlin, 10367

  • Study site

    Berlin, 13125

  • Study site

    Berlin, 4169

  • Study site

    Bonn, 53113

  • Study site

    Dortmund, 44137

  • Study site

    Freiburg im Breisgau, 79106

  • Study site

    Fürstenwalde, 15517

  • Study site

    Hamburg, 20357

  • Study site

    Karlsruhe, 76135

  • Study site

    Kiel, 24105

  • Study site

    Offenbach, 63069

  • Study site

    Stralsund, 18435

Other trials in Germany

United Kingdom13 sites

  • Study site

    Bournemouth, BH7 7DW

  • Study site

    Cardiff, CF14 2TL

  • Study site

    Denbigh, LL18 5UJ

  • Study site

    London, SE1 7EH

  • Study site

    London, SW3 6JJ

  • Study site

    Manchester, M20 4BX

  • Study site

    New Castle Upon Tyne, NE7 7DN

  • Study site

    Northwood, HA6 2RN

  • Study site

    Poole, BH15 2JB

  • Study site

    Preston, PR2 9HT

  • Study site

    Romford, RM7 0AG

  • Study site

    Sutton, SM2 5PT

  • Study site

    Weston-super-Mare, BS23 4TQ

Other trials in United Kingdom

Canada12 sites

  • Study site

    Calgary, Alberta, T2N 4N2

  • Study site

    Edmonton, Alberta, T6G 1Z2

  • Study site

    Greater Sudbury, Ontario, J9P 3Y1

  • Study site

    Greenfield Park, Quebec, J4V 2H1

  • Study site

    Halifax, Nova Scotia, B3H 2Y9

  • Study site

    Kelowna, British Columbia, V1Y 5L3

  • Study site

    Montreal, Quebec, H1T 2M4

  • Study site

    Montreal, Quebec, H2W 1T8

  • Study site

    Montreal, Quebec, H3T 1E2

  • Study site

    Ottawa, Ontario, K1H 8L6

  • Study site

    Toronto, Ontario, M4N 3M5

  • Study site

    Vancouver, British Columbia, V5Z 1H5

Other trials in Canada

France11 sites

  • Study site

    Avignon, 84082

  • Study site

    Bordeaux, 33076

  • Study site

    Brest, 29609

  • Study site

    Caen, 14076

  • Study site

    Dijon, 21079

  • Study site

    La Roche-sur-Yon, 85925

  • Study site

    Montpellier, 34298

  • Study site

    Paris, 75248

  • Study site

    Saint-Brieuc, 22015

  • Study site

    Saint-Herblain, 44805

  • Study site

    Vandœuvre-lès-Nancy, 54511

Other trials in France

Spain9 sites

  • Study site

    Barcelona, 08035

  • Study site

    Córdoba, 14004

  • Study site

    Lleida, 25198

  • Study site

    Madrid, 28041

  • Study site

    Madrid, 28046

  • Study site

    Santander, 39008

  • Study site

    Seville, 41013

  • Study site

    Valencia, 46009

  • Study site

    Zaragoza, 50009

Other trials in Spain

Poland7 sites

  • Study site

    Bialystok, 15-027

  • Study site

    Gdansk, 80-952

  • Study site

    Krakow, 31-531

  • Study site

    Lublin, 20-090

  • Study site

    Opole, 45-060

  • Study site

    Poznan, 61-866

  • Study site

    Warsaw, 02-781

Other trials in Poland

India5 sites

  • Study site

    Bangalore, 560027

  • Study site

    Gūrgaon, 122001

  • Study site

    Kolkata, 700 053

  • Study site

    New Delhi, 110029

  • Study site

    Pune, 411004

Other trials in India

Taiwan5 sites

  • Study site

    Kaohsung, 883

  • Study site

    Taichung, 404

  • Study site

    Taichung, 407

  • Study site

    Taipei, 112

  • Study site

    Taoyuan, 333

Other trials in Taiwan

Bulgaria4 sites

  • Study site

    Plovdiv, 4000

  • Study site

    Sofia, 1756

  • Study site

    Sofia, 1784

  • Study site

    Varna, 9002

Other trials in Bulgaria

South Korea4 sites

  • Study site

    Kyunggi-do, 411-769

  • Study site

    Seoul, 110-744

  • Study site

    Seoul, 120-752

  • Study site

    Seoul, 135-710

Other trials in South Korea

Colombia3 sites

  • Study site

    Bogotá, 0

  • Study site

    Bogotá, 49 00

  • Study site

    Montería

Other trials in Colombia

Denmark3 sites

  • Study site

    Copenhagen, 2100

  • Study site

    Herlev, 2730

  • Study site

    Odense, 5000

Other trials in Denmark

Finland3 sites

  • Study site

    Helsinki, 00180

  • Study site

    Tampere, 33520

  • Study site

    Turku, 20520

Other trials in Finland

Mexico3 sites

  • Study site

    Acapulco, 39670

  • Study site

    Oaxaca City, 68000

  • Study site

    Toluca, 50180

Other trials in Mexico

Portugal3 sites

  • Study site

    Coimbra, 3000-075

  • Study site

    Lisbon, 1649-035

  • Study site

    Porto, 4200-072

Other trials in Portugal

Russia3 sites

  • Study site

    Kemerovo, 650036

  • Study site

    Moscow, 121356

  • Study site

    Saint Petersburg, 197758

Other trials in Russia

Sweden3 sites

  • Study site

    Eskilstuna, 63188

  • Study site

    Gaelve, 80187

  • Study site

    Gothenburg, 40036

Other trials in Sweden

Bosnia and Herzegovina2 sites

  • Study site

    Banja Luka, 78000

  • Study site

    Sarajevo, 71000

Other trials in Bosnia and Herzegovina

New Zealand2 sites

  • Study site

    Newtown, 6021

  • Study site

    Palmerston North, 4442

Other trials in New Zealand

Philippines2 sites

  • Study site

    Diliman, Quezon City, 1100

  • Study site

    Quezon City, Luzon, 1101

Other trials in Philippines

Singapore2 sites

  • Study site

    Singapore, 119074

  • Study site

    Singapore, 169610

Other trials in Singapore

Switzerland2 sites

  • Study site

    Lucerne, 6004

  • Study site

    Sankt Gallen, 9007

Other trials in Switzerland

Hong Kong1 site

  • Study site

    Hong Kong

Other trials in Hong Kong

Slovenia1 site

  • Study site

    Ljubljana, 1000

Other trials in Slovenia

About this study

Official title: A Randomized, Multicenter, Phase III Open-label Study of the Efficacy and Safety of Trastuzumab MCC-DM1 vs. Capecitabine + Lapatinib in Patients With HER2-Positive Locally Advanced or Metastatic Breast Cancer Who Have Received Prior Trastuzumab-Based Therapy

This is a Phase III, randomized, multicenter, international, 2-arm, open-label clinical trial designed to compare the safety and efficacy of trastuzumab emtansine (T-DM1) with that of capecitabine + lapatinib in participants with human epidermal growth factor receptor 2 (HER2)-positive locally advanced or metastatic breast cancer. Participants will be treated until disease progression (PD), unmanageable toxicity, or study termination. Once disease progression is reported, all participants will be followed for survival every 3 months until death, loss to follow-up, withdrawal of consent, or study termination.

Conditions
Breast Cancer
Being tested
Trastuzumab emtansine, Lapatinib, Capecitabine
Medical subject headings
Breast Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Trastuzumab emtansineDrug

    Also called T-DM1, Trastuzumab-MCC-DM1, RO5304020

    Trastuzumab emtansine 3.6 mg/kg IV infusion over 30-90 minutes on Day 1 of each 21-day treatment cycle.

  • LapatinibDrug

    Also called Tykerb, Tyverb

    Lapatinib 1250 mg (five 250 mg tablets) orally once daily during each 21-day cycle.

  • CapecitabineDrug

    Also called Xeloda

    Capecitabine 1000 mg/m^2 orally twice daily on Days 1-14 of each 21-day treatment cycle.

Study groups in NCT00829166
Study groupRoleWhat they receive
Trastuzumab emtansineExperimentalParticipants will receive trastuzumab emtansine 3.6 milligrams per kilogram (mg/kg) intravenous (IV) infusion over 30-90 minutes on Day 1 of each 21-day treatment cycle until disease progression (PD) (as assessed by the investigator), unmanageable toxicity, or study termination.
Receives: Drug: Trastuzumab emtansine
Lapatinib + CapecitabineActive comparatorParticipants will receive lapatinib 1250 mg (five 250 mg tablets) orally once daily during each 21-day cycle + capecitabine 1000 milligrams per square meter (mg/m^2) orally twice daily on Days 1-14 of each 21-day treatment cycle until PD (as assessed by the investigator), unmanageable toxicity, or study termination. Eligible participants will cross over to receive trastuzumab emtansine if second interim analysis demonstrates statistically significant overall survival benefit in favor of trastuzumab emtansine.
Receives: Drug: Lapatinib; Drug: Capecitabine

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Percentage of Participants With PD or Death as Assessed by an Independent Review Committee (IRC)

    PD was assessed by an IRC using modified Response Evaluation Criteria in Solid Tumors (RECIST). All measurable lesions up to a maximum of 5 per organ and 10 in total were identified as target lesions (TLs) and recorded at baseline. TLs should be selected on the basis of their size (those with the longest diameter) and their suitability for accurate repeated measurements either by imaging or clinically. A sum of the longest diameter for all TLs was calculated as baseline sum longest diameter (SLD). All other lesions (or sites of disease) should be identified as non-TLs and recorded at baseline. PD for TLs was defined as greater than or equal to (>/=) 20 percent (%) increase in SLD, taking as reference smallest SLD recorded since treatment started or appearance of 1 or more new lesions. PD for non-TLs was defined as appearance of 1 or more new lesions and/or unequivocal progression of existing non-TLs. Percentage of Participants with PD by IRC or death from any cause was reported.

    Measured: From the date of randomization through the data cut-off date of 14 Jan 2012 (up to 2 years, 11 months)

  2. Progression-free Survival (PFS) as Assessed by an IRC (Co-primary Endpoint)

    Tumor response was assessed by an IRC according to modified RECIST. All measurable lesions up to a maximum of 5 per organ and 10 in total were identified as TLs (on the basis of their size and their suitability for accurate repeated measurements either by imaging or clinically) and recorded at baseline. A sum of the longest diameter for all TLs was calculated as baseline SLD. All other lesions were identified as non-TLs and recorded at baseline. PD for TLs: >/= 20% increase in the SLD, taking as reference the smallest SLD recorded since treatment started or appearance of 1 or more new lesions. PD for non-TLs: appearance of 1 or more new lesions and/or unequivocal progression of existing non-TLs. PFS: time from randomization to first documented PD by IRC or death from any cause (whichever occurred earlier). The median duration of PFS was estimated using Kaplan-Meier method. The 95% confidence interval (CI) was computed using the method of Brookmeyer and Crowley.

    Measured: From the date of randomization through the data cut-off date of 14 Jan 2012 (up to 2 years, 11 months)

  3. Percentage of Participants Who Died: Second Interim Analysis

    The percentage of participants who died from any cause was reported. The results are reported from second interim analysis, which deemed to be the confirmatory.

    Measured: From the date of randomization through the data cut-off date of 31 Jul 2012 (up to 3 years, 5 months)

  4. Overall Survival: Second Interim Analysis (Co-primary Endpoint)

    OS was defined as the time from the date of randomization to the date of death from any cause. The median duration of OS was estimated using Kaplan-Meier method. The 95% CI was computed using the method of Brookmeyer and Crowley. The results are reported from second interim analysis, which deemed to be the confirmatory.

    Measured: From the date of randomization through the data cut-off date of 31 Jul 2012 (up to 3 years, 5 months)

  5. Percentage of Participants Who Died: Final Analysis

    The percentage of participants who died from any cause was reported. The results reported are from the final analysis. The final analysis is descriptive.

    Measured: From the date of randomization through the data cut-off date of 31 Dec 2014 (up to 5 years, 11 months)

  6. Overall Survival: Final Analysis

    OS was defined as the time from the date of randomization to the date of death from any cause. The median duration of OS was estimated using Kaplan-Meier method. The 95% CI was computed using the method of Brookmeyer and Crowley. The results reported are from the final analysis. The final analysis is descriptive.

    Measured: From the date of randomization through the data cut-off date of 31 Dec 2014 (up to 5 years, 11 months)

  7. Percentage of Participants Who Were Alive at Year 1

    1 year survival was defined as the percentage of participants alive 1 year after starting treatment. The results reported are from the final analysis.

    Measured: Year 1

  8. Percentage of Participants Who Were Alive at Year 2

    2 year survival was defined as the percentage of participants alive 2 years after starting treatment. The results reported are from the final analysis.

    Measured: Year 2

Secondary outcomes (9)

  1. Percentage of Participants With PD or Death as Assessed by the Investigator

    PD was assessed by the investigator using modified RECIST. All measurable lesions up to a maximum of 5 per organ and 10 in total were identified as TLs and recorded at baseline. A sum of the longest diameter for all TLs was calculated as baseline SLD. PD for TLs was defined as >/=20% increase in the SLD, taking as reference the smallest SLD recorded since treatment started or the appearance of 1 or more new lesions. PD for non-TLs was defined as appearance of 1 or more new lesions and/or unequivocal progression of existing non-TLs. The percentage of participants who died or experienced PD by Investigator was reported.

    Measured: From the date of randomization through the data cut-off date of 14 Jan 2012 (up to 2 years, 11 months)

  2. PFS as Assessed by the Investigator

    Tumor response was assessed by the investigator according to modified RECIST. All measurable lesions up to a maximum of 5 per organ and 10 in total were identified as TLs and recorded at baseline. A sum of the longest diameter for all TLs was calculated as baseline SLD. PD for TLs was defined as >/=20% increase in the SLD, taking as reference the smallest SLD recorded since treatment started or the appearance of 1 or more new lesions. PD for non-TLs was defined as appearance of 1 or more new lesions and/or unequivocal progression of existing non-TLs. PFS was defined as the time from randomization to first documented PD by Investigator or death from any cause (whichever occurred earlier). The median duration of PFS was estimated using Kaplan-Meier method. The 95% CI was computed using the method of Brookmeyer and Crowley.

    Measured: From the date of randomization through the data cut-off date of 14 Jan 2012 (up to 2 years, 11 months)

  3. Percentage of Participants With Objective Response (OR) as Assessed by an IRC

    Tumor response was assessed by an IRC according to modified RECIST. OR was defined as the percentage of participants with a complete response (CR) or partial response (PR). All measurable lesions up to a maximum of 5 per organ and 10 in total were identified as TLs and recorded at baseline. A sum of the longest diameter for all TLs was calculated as baseline SLD. For TLs, a CR was defined as the disappearance of all TLs and a PR was defined as >/= 30% decrease in the SLD of TLs, taking as reference the baseline SLD. For non-TLs, a CR was defined as the disappearance of all non-TLs and a PR was defined as the persistence of 1 or more non-TLs. Confirmation of response at a consecutive tumor assessment at least 4 weeks apart was required. Participants without a post-baseline tumor assessment were considered non-responders. The percentage of participants with CR or PR by IRC was reported. The 95% CI was computed using Blyth-Still Casella exact CI method.

    Measured: From the date of randomization through the data cut-off date of 14 Jan 2012 (up to 2 years, 11 months)

  4. Duration of Objective Response (DOR) as Assessed by an IRC

    Tumor response was assessed by an IRC according to modified RECIST. DOR was defined as the time from first documented OR to first documented PD or death from any cause, whichever occurred earlier. OR was defined as a CR or PR determined on 2 consecutive tumor assessments at least 4 weeks apart. For TLs, CR was defined as the disappearance of all TLs; PR was defined as >/=30% decrease in the SLD of TLs, taking as reference the baseline SLD; and PD was defined as >/=20% increase in the SLD, taking as reference the smallest SLD recorded since treatment started or the appearance of 1 or more new lesions. For non-TLs, CR was defined as the disappearance of all non-TLs; PR was defined as the persistence of 1 or more non-TLs; and PD was defined as appearance of 1 or more new lesions and/or unequivocal progression of existing non-TLs. The 95% CI was computed using the method of Brookmeyer and Crowley.

    Measured: From the date of randomization through the data cut-off date of 14 Jan 2012 (up to 2 years, 11 months)

  5. Percentage of Participants With Clinical Benefit as Assessed by an IRC

    Tumor response was assessed by an IRC according to modified RECIST. Participants were considered as experienced clinical benefit if they had an OR or maintained stable disease (SD) for at least 6 months from randomization. OR: CR or PR determined on 2 consecutive tumor assessments >/=4 weeks apart. For TLs, CR: disappearance of all TLs; PR: >/=30% decrease in the SLD of TLs, taking as reference the baseline SLD; PD: >/=20% increase in the SLD, taking as reference the smallest SLD recorded since treatment started or appearance of 1 or more new lesions; and SD: neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD. For non-TLs, CR: disappearance of all non-TLs; PR/SD: persistence of 1 or more non-TLs; and PD: appearance of 1 or more new lesions and/or unequivocal progression of existing non-TLs. Participants without a post-baseline tumor assessment were considered non-responders. The 95% CI was computed using Blyth-Still Casella exact CI method.

    Measured: From the date of randomization through the data cut-off date of 14 Jan 2012 (up to 2 years, 11 months)

  6. Percentage of Participants With Treatment Failure

    Treatment failure was defined as discontinuation of treatment for any reason, including PD (per investigator review), treatment toxicity, or death from any cause. For "Lapatinib + Capecitabine" arm, a participant was considered as treatment failure only if both drugs were discontinued. For TLs, PD was defined as >/=20% increase in the SLD, taking as reference the smallest SLD recorded since treatment started or the appearance of 1 or more new lesions. For non-TLs, PD was defined as appearance of 1 or more new lesions and/or unequivocal progression of existing non-TLs. Percentage of participants with treatment failure was reported.

    Measured: From the date of randomization through the data cut-off date of 14 Jan 2012 (up to 2 years, 11 months)

  7. Time to Treatment Failure

    Time to treatment failure was defined as the time from randomization to discontinuation of treatment for any reason, including PD (per investigator review), treatment toxicity, or death from any cause. For "Lapatinib + Capecitabine" arm, a participant was considered as treatment failure only if both drugs were discontinued with treatment failure date as the later of the 2 discontinuation dates. For TLs, PD was defined as >/=20% increase in the SLD, taking as reference the smallest SLD recorded since treatment started or the appearance of 1 or more new lesions. For non-TLs, PD was defined as appearance of 1 or more new lesions and/or unequivocal progression of existing non-TLs. The median time to treatment failure was estimated using Kaplan-Meier method. The 95% CI was computed using the method of Brookmeyer and Crowley.

    Measured: From the date of randomization through the data cut-off date of 14 Jan 2012 (up to 2 years, 11 months)

  8. Percentage of Participants With Symptom Progression

    Symptom progression was defined as the documentation of a >/= 5-point decrease from baseline in the scoring of responses as measured by the Functional Assessment of Cancer Therapy-for participants with Breast Cancer (FACT-B) questionnaire with the Trial Outcomes Index-Physical/Functional/Breast (TOI-PFB) subscale. The FACT-B TOI-PFB subscale contained 24 items from 3 subsections of the FACT-B questionnaire: Physical well-being, functional well-being, and additional concerns for breast cancer participants (breast cancer subscale [BCS]). All items in the questionnaire were rated by the participant on a 5-point scale ranging from 0 ("not at all") to 4 ("very much"). The total score ranged from 0 to 96 with higher score indicating better perceived quality of life. The percentage of participants with symptom progression was reported.

    Measured: From the date of randomization through the data cut-off date of 14 Jan 2012 (up to 2 years, 11 months)

  9. Time to Symptom Progression

    Time to symptom progression was defined as the time from randomization to the first documentation of a >/= 5-point decrease from baseline in the scoring of responses as measured by the FACT-B questionnaire with the TOI-PFB subscale. The FACT-B TOI-PFB subscale contained 24 items from 3 subsections of the FACT-B questionnaire: Physical well-being, functional well-being, and additional concerns for breast cancer participants (BCS). All items in the questionnaire were rated by the participant on a 5-point scale ranging from 0 ("not at all") to 4 ("very much"). The total score ranged from 0 to 96 with higher score indicating better perceived quality of life. The median time to symptom progression was estimated using Kaplan-Meier method. The 95% CI was computed using the method of Brookmeyer and Crowley.

    Measured: From the date of randomization through the data cut-off date of 14 Jan 2012 (up to 2 years, 11 months)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Jan 2009 (estimated)
  2. Study startFeb 2009
  3. Primary completionJul 2012
  4. Study completionSep 2015

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
991 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00829166
Sponsor's protocol ID
BO21977
Other IDs
TDM4370g
Acronym
EMILIA
Status last verified
Sep 2016
First submitted
22 Jan 2009
Last updated
31 Oct 2016
Data monitoring committee
Yes

Publications

  • Dieras V, Miles D, Verma S, Pegram M, Welslau M, Baselga J, Krop IE, Blackwell K, Hoersch S, Xu J, Green M, Gianni L. Trastuzumab emtansine versus capecitabine plus lapatinib in patients with previously treated HER2-positive advanced breast cancer (EMILIA): a descriptive analysis of final overall survival results from a randomised, open-label, phase 3 trial. Lancet Oncol. 2017 Jun;18(6):732-742. doi: 10.1016/S1470-2045(17)30312-1. Epub 2017 May 16.

    PubMed 28526536

  • Verma S, Miles D, Gianni L, Krop IE, Welslau M, Baselga J, Pegram M, Oh DY, Dieras V, Guardino E, Fang L, Lu MW, Olsen S, Blackwell K; EMILIA Study Group. Trastuzumab emtansine for HER2-positive advanced breast cancer. N Engl J Med. 2012 Nov 8;367(19):1783-91. doi: 10.1056/NEJMoa1209124. Epub 2012 Oct 1.

    PubMed 23020162

  • Scott AM, Wolchok JD, Old LJ. Antibody therapy of cancer. Nat Rev Cancer. 2012 Mar 22;12(4):278-87. doi: 10.1038/nrc3236.

    PubMed 22437872

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Trastuzumab emtansine, Lapatinib and Capecitabine in people with Breast Cancer, run by Hoffmann-La Roche at 323 sites in 27 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 31 Oct 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 323 sites in United States, Brazil, Italy, Germany, United Kingdom and 22 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 23 Apr 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of Participants With PD or Death as Assessed by an Independent Review Committee (IRC) (time frame: From the date of randomization through the data cut-off date of 14 Jan 2012 (up to 2 years, 11 months)). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00829166, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Oct 2016.

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