AzTrials
AzTrials

Neoplasms, BreastPhase 3ALTTONCT00490139

ALTTO (Adjuvant Lapatinib And/Or Trastuzumab Treatment Optimisation) Study; BIG 2-06/N063D

A Phase 3 study testing Lapatinib and Trastuzumab in people with Neoplasms, Breast, run by Novartis Pharmaceuticals at 924 sites in 44 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 was a four-arm (parallel group) randomized, open-label, multicenter Phase 3 study to investigate the use of a combination of Lapatinib and Trastuzumab, a sequence of Trastuzumab followed by Lapatinib, and Lapatinib alone, compared to Trastuzumab alone in the adjuvant treatment of Human Epidermal Growth Factor… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Neoplasms, Breast
What is being tested?
Lapatinib and Trastuzumab
Could I receive a placebo?
No, everyone receives an active treatment
How many people
8,381 participants
Where
924 sitesin 44 countries
Study dates
16 May 2007to 1 Jul 2021
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

  • Patients >= 18 years of age with histologically confirmed, non-metastatic, operable and over expression/amplification of HER2 (3+ by IHC and/or FISH positive) primary breast cancer, treated with definitive surgery, with baseline LVEF >= 50%, known hormone receptor status (ER/PgR or ER alone) and ECOG performance status =< 1, were included.
  • For Designs 1 and 2: Patients must have had received at least four cycles of an approved anthracycline-based (neo-) adjuvant chemotherapy regimen or a protocol specified exception.
  • Approved, signed written informed consent obtained prior to any study specific screening procedures.

Who cannot join

  • History of any prior (ipsi- and/or contralateral) invasive breast carcinoma, past (less than 10 years) or current history of malignant neoplasms, any clinically staged T4 tumor, or bilateral tumors.
  • Concurrent anti-cancer treatment, except hormonal therapy or radiotherapy for the present breast cancer;
  • Patients with positive or suspicious internal mammary nodes identified by sentinel node technique, which had not been irradiated or would not be irradiated, or patients with supraclavicular lymph node involvement.
  • Any prior anti-HER therapy, which includes agents that target other members of the HER family of receptors, e.g. gefitinib (Iressa)
  • (Neo-) or adjuvant chemotherapy using peripheral stem cell or bone marrow stem cell support;
  • Serious cardiac illness or medical conditions.
Show all 16Show fewer
  • Any of the following abnormal laboratory tests immediately prior to randomization:
  • Serum total bilirubin >1.5 x upper limit of normal (ULN). In the case of known Gilbert's syndrome, a higher serum total bilirubin (<2 x ULN) was allowed;
  • Alanine amino transferase (ALT) or aspartate amino transferase (AST) >2.5 x ULN;
  • Alkaline phosphatase (ALP) >2.5 x ULN;
  • Serum creatinine >2.0 x ULN;
  • Total white blood cell count (WBC) <2.5 x 10^9/L;
  • Absolute neutrophil count <1.5 x 10^9/L;
  • Platelets <100 x 10^9/L.
  • Women of childbearing potential and male patients with partners of childbearing potential, who are unable or unwilling to use adequate contraceptive measures during study treatment, and pregnant or lactating women.
  • Concomitant use of CYP3A4 inhibitors or inducers.

Trial locations and contacts

924 sites in 44 countries.

924 sites in 44 countries

United States260 sites

  • Novartis Investigative Site

    Abington, Pennsylvania, 19001-3788

  • Novartis Investigative Site

    Adrian, Michigan, 49221

  • Novartis Investigative Site

    Albert Lea, Minnesota, 56007

  • Novartis Investigative Site

    Albuquerque, New Mexico, 87106

  • Novartis Investigative Site

    Albuquerque, New Mexico, 87110

  • Novartis Investigative Site

    Ames, Iowa, 50010

  • Novartis Investigative Site

    Anchorage, Alaska, 99508

  • Novartis Investigative Site

    Ann Arbor, Michigan, 48106-0995

  • Novartis Investigative Site

    Appleton, Wisconsin, 53715

  • Novartis Investigative Site

    Athens, Georgia, 30607

  • Novartis Investigative Site

    Atlanta, Georgia, 30309

  • Novartis Investigative Site

    Atlanta, Georgia, 30342

  • Novartis Investigative Site

    Augusta, Georgia, 30912

  • Novartis Investigative Site

    Aurora, Colorado, 80012

  • Novartis Investigative Site

    Baltimore, Maryland, 21201

  • Novartis Investigative Site

    Baltimore, Maryland, 21287-8936

  • Novartis Investigative Site

    Baton Rouge, Louisiana, 70809

  • Novartis Investigative Site

    Beaumont, Texas, 77702-1449

  • Novartis Investigative Site

    Bedford, Texas, 76022

  • Novartis Investigative Site

    Beech Grove, Indiana, 46107

  • Novartis Investigative Site

    Bellingham, Washington, 98225

  • Novartis Investigative Site

    Bethesda, Maryland, 20889-5600

  • Novartis Investigative Site

    Bethlehem, Pennsylvania, 18015

  • Novartis Investigative Site

    Bettendorf, Iowa, 52722

  • Novartis Investigative Site

    Billings, Montana, 59101

  • Novartis Investigative Site

    Bismarck, North Dakota, 58501

  • Novartis Investigative Site

    Boca Raton, Florida, 33486

  • Novartis Investigative Site

    Boise, Idaho, 83706

  • Novartis Investigative Site

    Boise, Idaho, 83712

  • Novartis Investigative Site

    Boston, Massachusetts, 02135

  • Novartis Investigative Site

    Boulder, Colorado, 80301

  • Novartis Investigative Site

    Bowling Green, Ohio, 43402

  • Novartis Investigative Site

    Bozeman, Montana, 59715

  • Novartis Investigative Site

    Buffalo, New York, 14263

  • Novartis Investigative Site

    Canton, Ohio, 44710

  • Novartis Investigative Site

    Cedar Rapids, Iowa, 52402

  • Novartis Investigative Site

    Chanute, Kansas, 66720

  • Novartis Investigative Site

    Chapel Hill, North Carolina, 27599

  • Novartis Investigative Site

    Charleston, South Carolina, 29406

  • Novartis Investigative Site

    Charleston, West Virginia, 25304

  • Novartis Investigative Site

    Chattanooga, Tennessee, 37403

  • Novartis Investigative Site

    Chattanooga, Tennessee, 37404

  • Novartis Investigative Site

    Chicago, Illinois, 60611

  • Novartis Investigative Site

    Chillicothe, Ohio, 54601

  • Novartis Investigative Site

    Chippewa Falls, Wisconsin, 54729

  • Novartis Investigative Site

    Cincinnati, Ohio, 45242

  • Novartis Investigative Site

    Clyde, Ohio, 43410

  • Novartis Investigative Site

    Colorado Springs, Colorado, 80907

  • Novartis Investigative Site

    Columbus, Georgia, 31904

  • Novartis Investigative Site

    Columbus, Ohio, 43210

  • Novartis Investigative Site

    Columbus, Ohio, 43214

  • Novartis Investigative Site

    Columbus, Ohio, 43215

  • Novartis Investigative Site

    Columbus, Ohio, 43222

  • Novartis Investigative Site

    Concord, New Hampshire, 03301

  • Novartis Investigative Site

    Cooperstown, New York, 13326

  • Novartis Investigative Site

    Dayton, Ohio, 45415

  • Novartis Investigative Site

    Dearborn, Michigan, 48123

  • Novartis Investigative Site

    Decatur, Georgia, 30033

  • Novartis Investigative Site

    Denver, Colorado, 80210

  • Novartis Investigative Site

    Denver, Colorado, 80218

  • Novartis Investigative Site

    Denver, Colorado, 80220

  • Novartis Investigative Site

    Des Moines, Iowa, 50309

  • Novartis Investigative Site

    Des Moines, Iowa, 50314

  • Novartis Investigative Site

    Detroit, Michigan, 48202

  • Novartis Investigative Site

    Dover, Delaware, 19901

  • Novartis Investigative Site

    Duarte, California, 91010

  • Novartis Investigative Site

    Duluth, Minnesota, 55805

  • Novartis Investigative Site

    East Syracuse, New York, 13057

  • Novartis Investigative Site

    Eau Claire, Wisconsin, 54702

  • Novartis Investigative Site

    Edina, Minnesota, 55435

  • Novartis Investigative Site

    El Dorado, Kansas, 67042

  • Novartis Investigative Site

    Eugene, Oregon, 97401

  • Novartis Investigative Site

    Evanston, Illinois, 60201

  • Novartis Investigative Site

    Fairfield, California, 94533

  • Novartis Investigative Site

    Fargo, North Dakota, 58122

  • Novartis Investigative Site

    Flint, Michigan, 48532

  • Novartis Investigative Site

    Fort Collins, Colorado, 80524

  • Novartis Investigative Site

    Fort Collins, Colorado, 80528

  • Novartis Investigative Site

    Fort Lauderdale, Florida, 33308

  • Novartis Investigative Site

    Fort Myers, Florida, 33916

  • Novartis Investigative Site

    Fort Sam Houston, Texas, 78234

  • Novartis Investigative Site

    Fort Wayne, Indiana, 46815

  • Novartis Investigative Site

    Fort Worth, Texas, 76104

  • Novartis Investigative Site

    Franklin, Ohio, 45005-1066

  • Novartis Investigative Site

    Frederick, Maryland, 21701

  • Novartis Investigative Site

    Grand Island, Nebraska, 68803

  • Novartis Investigative Site

    Great Falls, Montana, 59405

  • Novartis Investigative Site

    Green Bay, Wisconsin, 54301

  • Novartis Investigative Site

    Greenville, Ohio, 45331

  • Novartis Investigative Site

    Greenville, South Carolina, 29605

  • Novartis Investigative Site

    Hackensack, New Jersey, 07601

  • Novartis Investigative Site

    Hampton, Virginia, 23666

  • Novartis Investigative Site

    Hartford, Connecticut, 06105

  • Novartis Investigative Site

    Harvey, Illinois, 60426

  • Novartis Investigative Site

    Hendersonville, North Carolina, 28791

  • Novartis Investigative Site

    Hershey, Pennsylvania, 17033

  • Novartis Investigative Site

    Hollywood, Florida, 33021

  • Novartis Investigative Site

    Honolulu, Hawaii, 96813

  • Novartis Investigative Site

    Honolulu, Hawaii, 96859

  • Novartis Investigative Site

    Hooksett, New Hampshire, 03106

  • Novartis Investigative Site

    Houston, Texas, 77030

  • Novartis Investigative Site

    Huntington, West Virginia, 25701

  • Novartis Investigative Site

    Hyannis, Massachusetts, 02601

  • Novartis Investigative Site

    Independence, Kansas, 67301

  • Novartis Investigative Site

    Indianapolis, Indiana, 46202

  • Novartis Investigative Site

    Iron Mountain, Michigan, 49801

  • Novartis Investigative Site

    Jackson, Tennessee, 38301

  • Novartis Investigative Site

    Jacksonville, Florida, 32207

  • Novartis Investigative Site

    Jacksonville, Florida, 32224

  • Novartis Investigative Site

    Jonesboro, Arkansas, 72401

  • Novartis Investigative Site

    Kalamazoo, Michigan, 49007

  • Novartis Investigative Site

    Kankakee, Illinois, 60901

  • Novartis Investigative Site

    Kansas City, Missouri, 64131

  • Novartis Investigative Site

    Kettering, Ohio, 45429

  • Novartis Investigative Site

    Kingston, Pennsylvania, 18704

  • Novartis Investigative Site

    Kinston, North Carolina, 28501

  • Novartis Investigative Site

    Knoxville, Tennessee, 37920

  • Novartis Investigative Site

    Kokomo, Indiana, 46904

  • Novartis Investigative Site

    La Crosse, Wisconsin, 54601

  • Novartis Investigative Site

    La Jolla, California, 92093-0987

  • Novartis Investigative Site

    La Jolla, California, 92093

  • Novartis Investigative Site

    Lackland Air Force Base, Texas, 78236

  • Novartis Investigative Site

    Laconia, New Hampshire, 03246

  • Novartis Investigative Site

    Lakeland, Florida, 33805

  • Novartis Investigative Site

    Las Cruces, New Mexico, 88011

  • Novartis Investigative Site

    Las Vegas, Nevada, 89169

  • Novartis Investigative Site

    Lawrence, Kansas, 66044

  • Novartis Investigative Site

    Lebanon, New Hampshire, 03756

  • Novartis Investigative Site

    Lihue, Hawaii, 96766

  • Novartis Investigative Site

    Lincoln, Nebraska, 68510

  • Novartis Investigative Site

    Livingston, New Jersey, 07039

  • Novartis Investigative Site

    Loma Linda, California, 92534

  • Novartis Investigative Site

    Longview, Texas, 75601

  • Novartis Investigative Site

    Louisville, Kentucky, 40292

  • Novartis Investigative Site

    Madison, Wisconsin, 53717

  • Novartis Investigative Site

    Manhasset, New York, 11030

  • Novartis Investigative Site

    Mankato, Minnesota, 56002

  • Novartis Investigative Site

    Maplewood, Minnesota, 55109

  • Novartis Investigative Site

    Martinez, California, 94553-3156

  • Novartis Investigative Site

    Marysville, California, 95901

  • Novartis Investigative Site

    Mason City, Iowa

  • Novartis Investigative Site

    Maumee, Ohio, 43623

  • Novartis Investigative Site

    Maywood, Illinois, 60153

  • Novartis Investigative Site

    McAllen, Texas, 78503-1298

  • Novartis Investigative Site

    Memphis, Tennessee, 38120

  • Novartis Investigative Site

    Mesquite, Texas, 75150

  • Novartis Investigative Site

    Midland, Texas, 79701

  • Novartis Investigative Site

    Minneapolis, Minnesota, 55407-3799

  • Novartis Investigative Site

    Minneapolis, Minnesota, 55415

  • Novartis Investigative Site

    Minot, North Dakota, 58701

  • Novartis Investigative Site

    Mishawaka, Indiana, 46545

  • Novartis Investigative Site

    Mobile, Alabama, 36608

  • Novartis Investigative Site

    Mount Vernon, Illinois, 62864

  • Novartis Investigative Site

    Mountain View, California, 94040

  • Novartis Investigative Site

    Muncie, Indiana, 47303

  • Novartis Investigative Site

    Nashville, Pennsylvania, 37204

  • Novartis Investigative Site

    Nashville, Tennessee, 37203

  • Novartis Investigative Site

    Nashville, Tennessee, 37208

  • Novartis Investigative Site

    Nashville, Tennessee, 37232

  • Novartis Investigative Site

    New Brunswick, New Jersey, 08901

  • Novartis Investigative Site

    New Haven, Connecticut, 06520

  • Novartis Investigative Site

    New Orleans, Louisiana, 70112

  • Novartis Investigative Site

    New Orleans, Louisiana, 70121

  • Novartis Investigative Site

    New York, New York, 10003

  • Novartis Investigative Site

    New York, New York, 10011

  • Novartis Investigative Site

    New York, New York, 10016

  • Novartis Investigative Site

    New York, New York, 10032

  • Novartis Investigative Site

    Oak Lawn, Illinois, 60453-2699

  • Novartis Investigative Site

    Oakland, California, 94609

  • Novartis Investigative Site

    Ocala, Florida, 34474

  • Novartis Investigative Site

    Oklahoma City, Oklahoma, 73120

  • Novartis Investigative Site

    Omaha, Nebraska, 68106

  • Novartis Investigative Site

    Omaha, Nebraska, 68114

  • Novartis Investigative Site

    Omaha, Nebraska, 68122

  • Novartis Investigative Site

    Omaha, Nebraska, 68124

  • Novartis Investigative Site

    Omaha, Nebraska, 68131

  • Novartis Investigative Site

    Omaha, Nebraska, 68198

  • Novartis Investigative Site

    Orlando, Florida, 32803

  • Novartis Investigative Site

    Orlando, Florida, 32806

  • Novartis Investigative Site

    Oshkosh, Wisconsin, 54904

  • Novartis Investigative Site

    Ottawa, Illinois, 61350

  • Novartis Investigative Site

    Pascagoula, Mississippi, 39581

  • Novartis Investigative Site

    Peabody, Massachusetts, 01960

  • Novartis Investigative Site

    Pekin, Illinois, 61554

  • Novartis Investigative Site

    Peoria, Illinois, 61615

  • Novartis Investigative Site

    Peru, Illinois, 61354

  • Novartis Investigative Site

    Philadelphia, Pennsylvania, 19111

  • Novartis Investigative Site

    Pleasanton, California, 94588

  • Novartis Investigative Site

    Pontiac, Michigan, 48341-2985

  • Novartis Investigative Site

    Portland, Maine, 04101

  • Novartis Investigative Site

    Portland, Oregon, 97210

  • Novartis Investigative Site

    Pottstown, Pennsylvania, 19464

  • Novartis Investigative Site

    Prairie Village, Kansas, 66208

  • Novartis Investigative Site

    Pratt, Kansas, 67124

  • Novartis Investigative Site

    Princeton, Illinois, 61356

  • Novartis Investigative Site

    Princeton, New Jersey, 24740

  • Novartis Investigative Site

    Raleigh, North Carolina, 27607

  • Novartis Investigative Site

    Rapid City, South Dakota, 57701

  • Novartis Investigative Site

    Richmond, Virginia, 23230

  • Novartis Investigative Site

    Roanoke, Virginia, 24014

  • Novartis Investigative Site

    Rochester, New York, 14642

  • Novartis Investigative Site

    Rockford, Illinois, 61104

  • Novartis Investigative Site

    Rockford, Illinois, 61114

  • Novartis Investigative Site

    Sacramento, California, 95817

  • Novartis Investigative Site

    Saginaw, Michigan, 48601

  • Novartis Investigative Site

    Saint Cloud, Minnesota, 56303

  • Novartis Investigative Site

    Saint Joseph, Michigan, 49085

  • Novartis Investigative Site

    Saint Louis Park, Minnesota, 55416

  • Novartis Investigative Site

    Saint Paul, Minnesota, 55101

  • Novartis Investigative Site

    Saint Paul, Minnesota, 55102

  • Novartis Investigative Site

    Salt Lake City, Utah, 84112

  • Novartis Investigative Site

    San Antonio, Texas, 78209

  • Novartis Investigative Site

    San Antonio, Texas, 78229

  • Novartis Investigative Site

    San Francisco, California, 94110

  • Novartis Investigative Site

    Sandusky, Ohio, 44870

  • Novartis Investigative Site

    Savannah, Georgia, 31405

  • Novartis Investigative Site

    Sayre, Pennsylvania, 18840

  • Novartis Investigative Site

    Scarborough, Maine, 04074

  • Novartis Investigative Site

    Seattle, Washington, 98122

  • Novartis Investigative Site

    Seattle, Washington, 98133

  • Novartis Investigative Site

    Shakopee, Minnesota, 55379

  • Novartis Investigative Site

    Silver Spring, Maryland, 20910

  • Novartis Investigative Site

    Sioux City, Iowa, 51101-1733

  • Novartis Investigative Site

    Skokie, Illinois, 60077

  • Novartis Investigative Site

    Somerville, New Jersey, 08876

  • Novartis Investigative Site

    South Bend, Indiana, 46601

  • Novartis Investigative Site

    South Bend, Indiana, 46617

  • Novartis Investigative Site

    Southfield, Michigan, 48075

  • Novartis Investigative Site

    Sparta, New Jersey, 07871

  • Novartis Investigative Site

    Spokane, Washington, 99218

  • Novartis Investigative Site

    Springfield, Illinois, 62781-0001

  • Novartis Investigative Site

    Springfield, Missouri, 65807

  • Novartis Investigative Site

    St Louis, Missouri, 63110

  • Novartis Investigative Site

    Sturgeon Bay, Wisconsin, 54235

  • Novartis Investigative Site

    Sylvania, Ohio, 43560

  • Novartis Investigative Site

    Tacoma, Washington, 98405

  • Novartis Investigative Site

    The Bronx, New York, 10461

  • Novartis Investigative Site

    The Bronx, New York, 10467-2490

  • Novartis Investigative Site

    Thornton, Colorado, 80229

  • Novartis Investigative Site

    Toledo, Ohio, 43623

  • Novartis Investigative Site

    Topeka, Kansas, 66604

  • Novartis Investigative Site

    Topeka, Kansas, 66606

  • Novartis Investigative Site

    Towson, Maryland, 21204

  • Novartis Investigative Site

    Tucson, Arizona, 85715

  • Novartis Investigative Site

    Tulsa, Oklahoma, 74136

  • Novartis Investigative Site

    Tyler, Texas, 75702

  • Novartis Investigative Site

    Urbana, Illinois, 61801

  • Novartis Investigative Site

    Vineland, New Jersey, 08360

  • Novartis Investigative Site

    Waconia, Minnesota, 55387

  • Novartis Investigative Site

    Washington, North Carolina, 27889

  • Novartis Investigative Site

    Washington D.C., District of Columbia, 20007

  • Novartis Investigative Site

    Washington D.C., District of Columbia, 20307

  • Novartis Investigative Site

    Waterloo, Iowa, 50702

  • Novartis Investigative Site

    West Reading, Pennsylvania, 19611

  • Novartis Investigative Site

    Westminster, Maryland, 21157

  • Novartis Investigative Site

    Weston, Florida, 33331

  • Novartis Investigative Site

    Wheat Ridge, Colorado, 80033

  • Novartis Investigative Site

    Wichita, Kansas, 67214

  • Novartis Investigative Site

    Willmar, Minnesota, 56201

  • Novartis Investigative Site

    Winston-Salem, North Carolina, 27157

Other trials in United States

Germany176 sites

  • Novartis Investigative Site

    Ansbach, 91522

  • Novartis Investigative Site

    Aschaffenburg, 63739

  • Novartis Investigative Site

    Aschersleben, 06449

  • Novartis Investigative Site

    Aurich, 26603

  • Novartis Investigative Site

    Bad Oldesloe, 23843

  • Novartis Investigative Site

    Bad Reichenhall, 83435

  • Novartis Investigative Site

    Baden-Baden, 76532

  • Novartis Investigative Site

    Bayreuth, 95445

  • Novartis Investigative Site

    Bergisch Gladbach, 51465

  • Novartis Investigative Site

    Berlin, 10117

  • Novartis Investigative Site

    Berlin, 10317

  • Novartis Investigative Site

    Berlin, 10367

  • Novartis Investigative Site

    Berlin, 10967

  • Novartis Investigative Site

    Berlin, 12559

  • Novartis Investigative Site

    Berlin, 13125

  • Novartis Investigative Site

    Berlin, 13589

  • Novartis Investigative Site

    Berlin, 14169

  • Novartis Investigative Site

    Berlin, 14197

  • Novartis Investigative Site

    Bielefeld, 33604

  • Novartis Investigative Site

    Böblingen, 71032

  • Novartis Investigative Site

    Bonn, 53113

  • Novartis Investigative Site

    Bonn, 53127

  • Novartis Investigative Site

    Bonn, 53129

  • Novartis Investigative Site

    Brandenburg, 14770

  • Novartis Investigative Site

    Braunschweig, 38100

  • Novartis Investigative Site

    Bremen, 28209

  • Novartis Investigative Site

    Bremen, 28239

  • Novartis Investigative Site

    Bremerhaven, 27574

  • Novartis Investigative Site

    Chemnitz, 09116

  • Novartis Investigative Site

    Coburg, 96450

  • Novartis Investigative Site

    Cologne, 50677

  • Novartis Investigative Site

    Cologne, 50935

  • Novartis Investigative Site

    Cologne, 50937

  • Novartis Investigative Site

    Cuxhaven, 27474

  • Novartis Investigative Site

    Dachau, 85221

  • Novartis Investigative Site

    Deggendorf, 94469

  • Novartis Investigative Site

    Donauwörth, 86609

  • Novartis Investigative Site

    Dresden, 01127

  • Novartis Investigative Site

    Dresden, 01307

  • Novartis Investigative Site

    Duisburg, 47166

  • Novartis Investigative Site

    Düsseldorf, 40225

  • Novartis Investigative Site

    Düsseldorf, 40325

  • Novartis Investigative Site

    Eggenfelden, 84307

  • Novartis Investigative Site

    Erfurt, 99085

  • Novartis Investigative Site

    Erlangen, 91054

  • Novartis Investigative Site

    Eschweiler, 52249

  • Novartis Investigative Site

    Essen, 45122

  • Novartis Investigative Site

    Essen, 45130

  • Novartis Investigative Site

    Essen, 45136

  • Novartis Investigative Site

    Esslingen am Neckar, 73730

  • Novartis Investigative Site

    Flensburg, 24939

  • Novartis Investigative Site

    Frankfurt, 60389

  • Novartis Investigative Site

    Frankfurt, 60596

  • Novartis Investigative Site

    Frankfurt, 65929

  • Novartis Investigative Site

    Frankfurt am Main, 60590

  • Novartis Investigative Site

    Freiburg im Breisgau, 79106

  • Novartis Investigative Site

    Friedrichshafen, 88048

  • Novartis Investigative Site

    Fürstenwalde, 15517

  • Novartis Investigative Site

    Fürth, 90766

  • Novartis Investigative Site

    Garmisch-Partenkirchen, 82467

  • Novartis Investigative Site

    Georgsmarienhütte, 49124

  • Novartis Investigative Site

    Gera, 07548

  • Novartis Investigative Site

    Göppingen, 73035

  • Novartis Investigative Site

    Goslar, 38642

  • Novartis Investigative Site

    Göttingen, 37075

  • Novartis Investigative Site

    Greifswald, 17487

  • Novartis Investigative Site

    Gummersbach, 51643

  • Novartis Investigative Site

    Güstrow, 18273

  • Novartis Investigative Site

    Halle, 06110

  • Novartis Investigative Site

    Halle, 06120

  • Novartis Investigative Site

    Hamburg, 20246

  • Novartis Investigative Site

    Hamburg, 20259

  • Novartis Investigative Site

    Hamburg, 20357

  • Novartis Investigative Site

    Hamburg, 22081

  • Novartis Investigative Site

    Hamburg, 22359

  • Novartis Investigative Site

    Hamburg, 22457

  • Novartis Investigative Site

    Hamelin, 31785

  • Novartis Investigative Site

    Hamm-Heessen, 59073

  • Novartis Investigative Site

    Hanover, 30177

  • Novartis Investigative Site

    Hanover, 30559

  • Novartis Investigative Site

    Heide, 25746

  • Novartis Investigative Site

    Heidelberg, 69115

  • Novartis Investigative Site

    Heidelberg, 69120

  • Novartis Investigative Site

    Herne, 44623

  • Novartis Investigative Site

    Homburg, 66421

  • Novartis Investigative Site

    Hoyerswerda, 02977

  • Novartis Investigative Site

    Itzehoe, 25524

  • Novartis Investigative Site

    Jena, 07743

  • Novartis Investigative Site

    Karlsruhe, 76135

  • Novartis Investigative Site

    Karlsruhe, 76199

  • Novartis Investigative Site

    Kassel, 34117

  • Novartis Investigative Site

    Kassel, 34125

  • Novartis Investigative Site

    Kempten, 87439

  • Novartis Investigative Site

    Kiel, 24103

  • Novartis Investigative Site

    Kiel, 24105

  • Novartis Investigative Site

    Konstanz, 78464

  • Novartis Investigative Site

    Landshut, 84034

  • Novartis Investigative Site

    Landshut, 84036

  • Novartis Investigative Site

    Landstuhl, 66849

  • Novartis Investigative Site

    Leer, 26789

  • Novartis Investigative Site

    Leipzig, 04129

  • Novartis Investigative Site

    Leipzig, 04277

  • Novartis Investigative Site

    Leverkusen, 51375

  • Novartis Investigative Site

    Limburg, 65549

  • Novartis Investigative Site

    Loerrach, 79539

  • Novartis Investigative Site

    Lübeck, 23538

  • Novartis Investigative Site

    Luckenwalde, 14943

  • Novartis Investigative Site

    Ludwigsburg, 71640

  • Novartis Investigative Site

    Ludwigsfelde, 14974

  • Novartis Investigative Site

    Ludwigshafen, 67063

  • Novartis Investigative Site

    Magdeburg, 39130

  • Novartis Investigative Site

    Mainz, 55131

  • Novartis Investigative Site

    Mannheim, 68165

  • Novartis Investigative Site

    Mannheim, 68167

  • Novartis Investigative Site

    Marktredwitz, 95615

  • Novartis Investigative Site

    Meiningen, 98617

  • Novartis Investigative Site

    Memmingen, 87700

  • Novartis Investigative Site

    Minden, 32429

  • Novartis Investigative Site

    Mönchengladbach, 41061

  • Novartis Investigative Site

    Mühlhausen, 99974

  • Novartis Investigative Site

    München, 80335

  • Novartis Investigative Site

    München, 80638

  • Novartis Investigative Site

    München, 81675

  • Novartis Investigative Site

    München, 81925

  • Novartis Investigative Site

    Münster, 48149

  • Novartis Investigative Site

    Mutlangen, 73557

  • Novartis Investigative Site

    Neumünster, 24534

  • Novartis Investigative Site

    Neunkirchen, 66539

  • Novartis Investigative Site

    Nuremberg, 90491

  • Novartis Investigative Site

    Offenbach, 63069

  • Novartis Investigative Site

    Oldenburg, 26121

  • Novartis Investigative Site

    Oldenburg, 26133

  • Novartis Investigative Site

    Olpe, 57462

  • Novartis Investigative Site

    Osnabrück, 49074

  • Novartis Investigative Site

    Ostfildern, 73760

  • Novartis Investigative Site

    Porta Westfalica, 32457

  • Novartis Investigative Site

    Radebeul, 01445

  • Novartis Investigative Site

    Ravensburg, 88212

  • Novartis Investigative Site

    Rendsburg, 24768

  • Novartis Investigative Site

    Reutlingen, 72764

  • Novartis Investigative Site

    Rheinfelden, 79618

  • Novartis Investigative Site

    Rodewisch, 08228

  • Novartis Investigative Site

    Rosenheim, 83022

  • Novartis Investigative Site

    Rostock, 18059

  • Novartis Investigative Site

    Rotenburg (Wümme), 27356

  • Novartis Investigative Site

    Saarbrücken, 66113

  • Novartis Investigative Site

    Schkeuditz, 04435

  • Novartis Investigative Site

    Schwäbisch Hall, 74523

  • Novartis Investigative Site

    Sigmaringen, 72488

  • Novartis Investigative Site

    Stade, 21680

  • Novartis Investigative Site

    Stadthagen, 31655

  • Novartis Investigative Site

    Stendal, 39576

  • Novartis Investigative Site

    Stralsund, 18435

  • Novartis Investigative Site

    Stuttgart, 70174

  • Novartis Investigative Site

    Stuttgart, 70376

  • Novartis Investigative Site

    Torgau, 04860

  • Novartis Investigative Site

    Trier, 54290

  • Novartis Investigative Site

    Troisdorf, 53840

  • Novartis Investigative Site

    Tübingen, 72076

  • Novartis Investigative Site

    Ulm, 89075

  • Novartis Investigative Site

    Vechta, 49377

  • Novartis Investigative Site

    Velbert, 42551

  • Novartis Investigative Site

    Villingen-Schwenningen, 78050

  • Novartis Investigative Site

    Weißenfels, 06667

  • Novartis Investigative Site

    Wesel, 46485

  • Novartis Investigative Site

    Westerstede, 26655

  • Novartis Investigative Site

    Wiesbaden, 65189

  • Novartis Investigative Site

    Wiesbaden, 65191

  • Novartis Investigative Site

    Wiesbaden, 65199

  • Novartis Investigative Site

    Witten, 58452

  • Novartis Investigative Site

    Wuppertal, 42105

  • Novartis Investigative Site

    Wuppertal, 42283

  • Novartis Investigative Site

    Würselen, 52146

  • Novartis Investigative Site

    Würzburg, 97080

  • Novartis Investigative Site

    Zittau, 02763

  • Novartis Investigative Site

    Zwickau, 08060

Other trials in Germany

France50 sites

  • Novartis Investigative Site

    Angers, 49055

  • Novartis Investigative Site

    Annecy, 74000

  • Novartis Investigative Site

    Avignon, 84000

  • Novartis Investigative Site

    Bayonne, 64100

  • Novartis Investigative Site

    Béthune, 62400

  • Novartis Investigative Site

    Brive-la-Gaillarde, 19100

  • Novartis Investigative Site

    Bron, 69677

  • Novartis Investigative Site

    Caen, 14076

  • Novartis Investigative Site

    Clermont-Ferrand, 63000

  • Novartis Investigative Site

    Coudekerque-Branche, 59210

  • Novartis Investigative Site

    Dijon, 21079

  • Novartis Investigative Site

    Draguignan, 83007

  • Novartis Investigative Site

    Grenoble, 38028

  • Novartis Investigative Site

    Hyères, 83400

  • Novartis Investigative Site

    La Seyne-sur-Mer, 83500

  • Novartis Investigative Site

    Le Mans, 72000

  • Novartis Investigative Site

    Lille, 59000

  • Novartis Investigative Site

    Lyon, 69008

  • Novartis Investigative Site

    Lyon, 69337

  • Novartis Investigative Site

    Marseille, 13273

  • Novartis Investigative Site

    Marseille, 13285

  • Novartis Investigative Site

    Marseille, 13385

  • Novartis Investigative Site

    Metz, 57045

  • Novartis Investigative Site

    Mont-de-Marsan, 40024

  • Novartis Investigative Site

    Montbéliard, 25200

  • Novartis Investigative Site

    Nancy, 54100

  • Novartis Investigative Site

    Nice, 06189

  • Novartis Investigative Site

    Nîmes, 30029

  • Novartis Investigative Site

    Paris, 75248

  • Novartis Investigative Site

    Paris, 75475

  • Novartis Investigative Site

    Paris, 75674

  • Novartis Investigative Site

    Périgueux, 24004

  • Novartis Investigative Site

    Perin Sur Mer, 22190

  • Novartis Investigative Site

    Perpignan, 66000

  • Novartis Investigative Site

    Reims, 51100

  • Novartis Investigative Site

    Rouen, 76000

  • Novartis Investigative Site

    Rouen, 76038

  • Novartis Investigative Site

    Saint-Cloud, 92210

  • Novartis Investigative Site

    Saint-Grégoire, 67085

  • Novartis Investigative Site

    Saint-Herblain, 44805

  • Novartis Investigative Site

    Saint-Jean, 31240

  • Novartis Investigative Site

    Saint-Priest-en-Jarez, 42271

  • Novartis Investigative Site

    Strasbourg, 67000

  • Novartis Investigative Site

    Strasbourg, 67085

  • Novartis Investigative Site

    Toulouse, 31077

  • Novartis Investigative Site

    Toulouse, 31300

  • Novartis Investigative Site

    Tours, 37044

  • Novartis Investigative Site

    Valenciennes, 59322

  • Novartis Investigative Site

    Vandœuvre-lès-Nancy, 54511

  • Novartis Investigative Site

    Villejuif, 94805

Other trials in France

United Kingdom43 sites

  • Novartis Investigative Site

    Blackpool, FY3 8NR

  • Novartis Investigative Site

    Bournemouth, BH7 7DW

  • Novartis Investigative Site

    Brighton, BN2 5BE

  • Novartis Investigative Site

    Canterbury, Kent, CT1 3NG

  • Novartis Investigative Site

    Cardiff, CF14 2TL

  • Novartis Investigative Site

    Chelmsford, CM1 7ET

  • Novartis Investigative Site

    Cheltenham, GL53 7AN

  • Novartis Investigative Site

    Cottingham, HU16 5JQ

  • Novartis Investigative Site

    Dorchester, DT1 2JY

  • Novartis Investigative Site

    Edinburgh, EH4 2XU

  • Novartis Investigative Site

    Exeter, EX2 5DW

  • Novartis Investigative Site

    Grimsby, DN33 2BA

  • Novartis Investigative Site

    Guildford, GU2 7XX

  • Novartis Investigative Site

    Gwynedd, LL57 2PW

  • Novartis Investigative Site

    Huddersfield, HD3 3EA

  • Novartis Investigative Site

    Ipswich, IP4 5PD

  • Novartis Investigative Site

    Lancaster, LA1 4RP

  • Novartis Investigative Site

    Leeds, LS9 7TF

  • Novartis Investigative Site

    Liverpool, L7 8XP

  • Novartis Investigative Site

    London, EC1A 7BE

  • Novartis Investigative Site

    London, NW1 2PG

  • Novartis Investigative Site

    London, SW17 0QT

  • Novartis Investigative Site

    London, W2 1NY

  • Novartis Investigative Site

    London, W6 8RF

  • Novartis Investigative Site

    Maidstone, ME16 9QQ

  • Novartis Investigative Site

    Manchester, M20 4BX

  • Novartis Investigative Site

    Newcastle upon Tyne, NE7 7DN

  • Novartis Investigative Site

    Northwood, HA6 2RN

  • Novartis Investigative Site

    Nottingham, NG5 1PB

  • Novartis Investigative Site

    Oxford, OX3 7LJ

  • Novartis Investigative Site

    Plymouth, PL6 8DH

  • Novartis Investigative Site

    Poole, BH15 2JB

  • Novartis Investigative Site

    Portsmouth, PO6 3LY

  • Novartis Investigative Site

    Preston, PR2 9HT

  • Novartis Investigative Site

    Prittlewell Chase, SS0 0RY

  • Novartis Investigative Site

    Romford, RM7 0AG

  • Novartis Investigative Site

    Sheffield, S10 2SJ

  • Novartis Investigative Site

    Shrewsbury, SY3 8XQ

  • Novartis Investigative Site

    St Helens, WA9 3DA

  • Novartis Investigative Site

    Stoke-on-Trent, ST4 6QG

  • Novartis Investigative Site

    Sutton, SM2 5PT

  • Novartis Investigative Site

    Swansea, SA2 8QA

  • Novartis Investigative Site

    Worthing, BN11 2DH

Other trials in United Kingdom

Italy42 sites

  • Novartis Investigative Site

    Asti, 14100

  • Novartis Investigative Site

    Avellino, 83100

  • Novartis Investigative Site

    Aviano, 33081

  • Novartis Investigative Site

    Bergamo, 24127

  • Novartis Investigative Site

    Biella, 13900

  • Novartis Investigative Site

    Brescia, 25123

  • Novartis Investigative Site

    Brescia, 25124

  • Novartis Investigative Site

    Brindisi, 72100

  • Novartis Investigative Site

    Candiolo, 10060

  • Novartis Investigative Site

    Carpi, 41012

  • Novartis Investigative Site

    Cosenza, 87100

  • Novartis Investigative Site

    Cremona, 26100

  • Novartis Investigative Site

    Fano, 61032

  • Novartis Investigative Site

    Fermo, 63023

  • Novartis Investigative Site

    Florence, 50134

  • Novartis Investigative Site

    Genova, 16132

  • Novartis Investigative Site

    Lecce, 73100

  • Novartis Investigative Site

    Lecco, 23900

  • Novartis Investigative Site

    Lido di Camaiore, 55043

  • Novartis Investigative Site

    Livorno, 57123

  • Novartis Investigative Site

    Mantua, 46100

  • Novartis Investigative Site

    Meldola, 47014

  • Novartis Investigative Site

    Milan, 20142

  • Novartis Investigative Site

    Milan, 20162

  • Novartis Investigative Site

    Monserrato, 09042

  • Novartis Investigative Site

    Monza, 20052

  • Novartis Investigative Site

    Pavia, 27100

  • Novartis Investigative Site

    Poggibonsi, 53036

  • Novartis Investigative Site

    Potenza, 85100

  • Novartis Investigative Site

    Prato, 59100

  • Novartis Investigative Site

    Ragusa, 97100

  • Novartis Investigative Site

    Ravenna, 48100

  • Novartis Investigative Site

    Rimini, 47900

  • Novartis Investigative Site

    Rozzano, 20089

  • Novartis Investigative Site

    San Fermo della Battaglia, 22020

  • Novartis Investigative Site

    Saronno, 21047

  • Novartis Investigative Site

    Sassari, 07100

  • Novartis Investigative Site

    Trento, 38122

  • Novartis Investigative Site

    Treviglio, 24027

  • Novartis Investigative Site

    Udine, 33100

  • Novartis Investigative Site

    Varese, 21100

  • Novartis Investigative Site

    Viterbo, 01100

Other trials in Italy

Spain37 sites

  • Novartis Investigative Site

    Alcoy, 03804

  • Novartis Investigative Site

    Barcelona, 08035

  • Novartis Investigative Site

    Barcelona, 08907

  • Novartis Investigative Site

    Burgos, 09006

  • Novartis Investigative Site

    Cadiz, 11009

  • Novartis Investigative Site

    Castellon, 12002

  • Novartis Investigative Site

    Córdoba, 14004

  • Novartis Investigative Site

    Donostia / San Sebastian, 20014

  • Novartis Investigative Site

    Elda, 03600

  • Novartis Investigative Site

    Granada, 18014

  • Novartis Investigative Site

    Lleida, 25198

  • Novartis Investigative Site

    Lugo, 27003

  • Novartis Investigative Site

    Madrid, 28006

  • Novartis Investigative Site

    Madrid, 28007

  • Novartis Investigative Site

    Madrid, 28033

  • Novartis Investigative Site

    Madrid, 28041

  • Novartis Investigative Site

    Madrid, 28046

  • Novartis Investigative Site

    Madrid, 28460

  • Novartis Investigative Site

    Málaga, 29010

  • Novartis Investigative Site

    Mataró, 08034

  • Novartis Investigative Site

    Móstoles, 28460

  • Novartis Investigative Site

    Murcia, 30008

  • Novartis Investigative Site

    Palma de Mallorca, 07010

  • Novartis Investigative Site

    Palma de Mallorca, 07198

  • Novartis Investigative Site

    Pamplona, 31008

  • Novartis Investigative Site

    Salamanca, 37007

  • Novartis Investigative Site

    Santa Cruz de Tenerife, 38320

  • Novartis Investigative Site

    Santander, 39008

  • Novartis Investigative Site

    Santiago, 15705

  • Novartis Investigative Site

    Segovia, 40002

  • Novartis Investigative Site

    Seville, 41009

  • Novartis Investigative Site

    Seville, 41014

  • Novartis Investigative Site

    Tarrasa, Barcelona, 08221

  • Novartis Investigative Site

    Toledo, 45004

  • Novartis Investigative Site

    Valencia, 46014

  • Novartis Investigative Site

    Vizcaya, 48903

  • Novartis Investigative Site

    Zamora

Other trials in Spain

Australia32 sites

  • Novartis Investigative Site

    Adelaide, 5000

  • Novartis Investigative Site

    Bedford Park, 5042

  • Novartis Investigative Site

    Box Hill, Victoria, 3128

  • Novartis Investigative Site

    Bunbury, 6230

  • Novartis Investigative Site

    Campbelltown, 2560

  • Novartis Investigative Site

    Camperdown, 2050

  • Novartis Investigative Site

    Coffs Harbour, 2450

  • Novartis Investigative Site

    Concord, 2139

  • Novartis Investigative Site

    East Bentleigh, 3165

  • Novartis Investigative Site

    East Melbourne, 3002

  • Novartis Investigative Site

    Heidelberg, 3084

  • Novartis Investigative Site

    Hobart, 7000

  • Novartis Investigative Site

    Lismore, 2480

  • Novartis Investigative Site

    Liverpool, 2170

  • Novartis Investigative Site

    Melbourne, 3002

  • Novartis Investigative Site

    Murdoch, 6150

  • Novartis Investigative Site

    Nambour, 4560

  • Novartis Investigative Site

    Nedlands, 6009

  • Novartis Investigative Site

    North Sydney, 2060

  • Novartis Investigative Site

    Parkville, 3050

  • Novartis Investigative Site

    Port Macquarie, 2444

  • Novartis Investigative Site

    Randwick, 2031

  • Novartis Investigative Site

    South Brisbane, 4101

  • Novartis Investigative Site

    Subiaco, 6008

  • Novartis Investigative Site

    Taree, 2430

  • Novartis Investigative Site

    Tweed Heads, 2485

  • Novartis Investigative Site

    Wagga Wagga, 2650

  • Novartis Investigative Site

    Waratah, 2298

  • Novartis Investigative Site

    Wendouree, 3355

  • Novartis Investigative Site

    Westmead, 2145

  • Novartis Investigative Site

    Woodville, 5011

  • Novartis Investigative Site

    Woolloongabba, 4102

Other trials in Australia

Belgium29 sites

  • Novartis Investigative Site

    Aalst, 9300

  • Novartis Investigative Site

    Antwerp, 2020

  • Novartis Investigative Site

    Bonheiden, 2820

  • Novartis Investigative Site

    Bruges, 8000

  • Novartis Investigative Site

    Brussels, 1000

  • Novartis Investigative Site

    Brussels, 1020

  • Novartis Investigative Site

    Brussels, 1050

  • Novartis Investigative Site

    Brussels, 1070

  • Novartis Investigative Site

    Brussels, 1200

  • Novartis Investigative Site

    Charleroi, 6000

  • Novartis Investigative Site

    Edegem, 2650

  • Novartis Investigative Site

    Genk, 3600

  • Novartis Investigative Site

    Ghent, 9000

  • Novartis Investigative Site

    Haine-Saint-Paul, 7100

  • Novartis Investigative Site

    Hasselt, 3500

  • Novartis Investigative Site

    Huy, 4500

  • Novartis Investigative Site

    Jette, 1090

  • Novartis Investigative Site

    Kortrijk, 8500

  • Novartis Investigative Site

    Leuven, 3000

  • Novartis Investigative Site

    Liège, 4000

  • Novartis Investigative Site

    Mons, 7000

  • Novartis Investigative Site

    Namur, 5000

  • Novartis Investigative Site

    Roeselare, 8800

  • Novartis Investigative Site

    Sint-Niklaas, 9100

  • Novartis Investigative Site

    Tournai, 7500

  • Novartis Investigative Site

    Turnhout, 2300

  • Novartis Investigative Site

    Verviers, 4800

  • Novartis Investigative Site

    Wilrijk, 2610

  • Novartis Investigative Site

    Yvoir, 5530

Other trials in Belgium

Netherlands17 sites

  • Novartis Investigative Site

    Amsterdam, 1081 HV

  • Novartis Investigative Site

    Arnhem, 6815 AD

  • Novartis Investigative Site

    Delft, 2625 AD

  • Novartis Investigative Site

    Eindhoven, 5623 EJ

  • Novartis Investigative Site

    Gouda, 2803 HH

  • Novartis Investigative Site

    Hilversum, 1213 XZ

  • Novartis Investigative Site

    Hoogeveen, 7909 AA

  • Novartis Investigative Site

    Leeuwarden, 8934 AD

  • Novartis Investigative Site

    Leiden, 2333 ZA

  • Novartis Investigative Site

    Leidschendam, 2262 BA

  • Novartis Investigative Site

    Purmerend, 1441 RN

  • Novartis Investigative Site

    Rotterdam, 3083 AN

  • Novartis Investigative Site

    Sittard-Geleen, 6162 BG

  • Novartis Investigative Site

    The Hague, 2512 VA

  • Novartis Investigative Site

    The Hague, 2545 CH

  • Novartis Investigative Site

    Tilburg, 5022 GC

  • Novartis Investigative Site

    Utrecht, 3582 KE

Other trials in Netherlands

Japan15 sites

  • Novartis Investigative Site

    Aichi, 464-8681

  • Novartis Investigative Site

    Chiba, 277-8577

  • Novartis Investigative Site

    Ehime, 791-0280

  • Novartis Investigative Site

    Fukuoka, 811-1395

  • Novartis Investigative Site

    Ibaraki, 305-8576

  • Novartis Investigative Site

    Kanagawa, 259-1143

  • Novartis Investigative Site

    Kyoto, 606-8507

  • Novartis Investigative Site

    Osaka, 530-8480

  • Novartis Investigative Site

    Osaka, 540-0006

  • Novartis Investigative Site

    Saitama, 350-1298

  • Novartis Investigative Site

    Tokyo, 101-8643

  • Novartis Investigative Site

    Tokyo, 104-0045

  • Novartis Investigative Site

    Tokyo, 104-8560

  • Novartis Investigative Site

    Tokyo, 113-8677

  • Novartis Investigative Site

    Tokyo, 135-8550

Other trials in Japan

Russia15 sites

  • Novartis Investigative Site

    Arkhangelsk, 163045

  • Novartis Investigative Site

    Chelyabinsk, 454087

  • Novartis Investigative Site

    Irkutsk, 664035

  • Novartis Investigative Site

    Kazan', 420029

  • Novartis Investigative Site

    Kirov, 610021

  • Novartis Investigative Site

    Moscow, 115478

  • Novartis Investigative Site

    Moscow, 121359

  • Novartis Investigative Site

    Novosibirsk, 630047

  • Novartis Investigative Site

    Omsk, 644013

  • Novartis Investigative Site

    Orenburg, 460021

  • Novartis Investigative Site

    Ryazan, 390011

  • Novartis Investigative Site

    Saint Petersburg, 197022

  • Novartis Investigative Site

    Saint Petersburg, 197758

  • Novartis Investigative Site

    Samara, 443031

  • Novartis Investigative Site

    Voronezh, 394062

Other trials in Russia

Czechia14 sites

  • Novartis Investigative Site

    Brno, 625 00

  • Novartis Investigative Site

    Brno, 656 53

  • Novartis Investigative Site

    Brno, 656 91

  • Novartis Investigative Site

    České Budějovice, 370 87

  • Novartis Investigative Site

    Chomutov, 43012

  • Novartis Investigative Site

    Jihlava, 586 01

  • Novartis Investigative Site

    Nový Jičín, 741 01

  • Novartis Investigative Site

    Pardubice, 532 03

  • Novartis Investigative Site

    Prague, 100 34

  • Novartis Investigative Site

    Prague, 128 08

  • Novartis Investigative Site

    Prague, 140 59

  • Novartis Investigative Site

    Prague, 150 08

  • Novartis Investigative Site

    Prague, 180 00

  • Novartis Investigative Site

    Ústí nad Labem, 40113

Other trials in Czechia

Poland12 sites

  • Novartis Investigative Site

    Bydgoszcz, 85-796

  • Novartis Investigative Site

    Gdansk, 80-210

  • Novartis Investigative Site

    Gdansk, 80-214

  • Novartis Investigative Site

    Gliwice, 44-101

  • Novartis Investigative Site

    Krakow, 31-115

  • Novartis Investigative Site

    Olsztyn, 10-226

  • Novartis Investigative Site

    Olsztyn, 10-228

  • Novartis Investigative Site

    Opole, 45-060

  • Novartis Investigative Site

    Rzeszów, 35-021

  • Novartis Investigative Site

    Szczecin, 71-730

  • Novartis Investigative Site

    Warsaw, 02-781

  • Novartis Investigative Site

    Wroclaw, 53-413

Other trials in Poland

Denmark11 sites

  • Novartis Investigative Site

    Aalborg, 9100

  • Novartis Investigative Site

    Arhus C, 8000

  • Novartis Investigative Site

    Esbjerg, 6700

  • Novartis Investigative Site

    Herlev, 2730

  • Novartis Investigative Site

    Hilleroed, 3400

  • Novartis Investigative Site

    Koebenhavn Oe, 2100

  • Novartis Investigative Site

    Næstved, 4700

  • Novartis Investigative Site

    Odense, 5000

  • Novartis Investigative Site

    Roskilde, 4000

  • Novartis Investigative Site

    Vejle, 7100

  • Novartis Investigative Site

    Viborg, 8800

Other trials in Denmark

Brazil10 sites

  • Novartis Investigative Site

    Belo Horizonte, 30150-270

  • Novartis Investigative Site

    Jaú, São Paulo, 17210-120

  • Novartis Investigative Site

    Porte Alegre, 90430-001

  • Novartis Investigative Site

    Porto Alegre, 90050-170

  • Novartis Investigative Site

    Porto Alegre, 90430-090

  • Novartis Investigative Site

    Porto Alegre, 90560-030

  • Novartis Investigative Site

    Porto Alegre, 90610000

  • Novartis Investigative Site

    Rio de Janeiro, 20560-120

  • Novartis Investigative Site

    Salvador, 40050-410

  • Novartis Investigative Site

    Santo André, 09060-650

Other trials in Brazil

Canada10 sites

  • Novartis Investigative Site

    Charlottetown, C1A 8T5

  • Novartis Investigative Site

    Kelowna, V1Y 5L3

  • Novartis Investigative Site

    London, N6A 4L6

  • Novartis Investigative Site

    Moncton, E1C 8X3

  • Novartis Investigative Site

    Regina, S4T 7T1

  • Novartis Investigative Site

    Sault Ste. Marie, P6A 2C4

  • Novartis Investigative Site

    Sherbrooke, J1H 5N4

  • Novartis Investigative Site

    St. Catharines, L2R 7C6

  • Novartis Investigative Site

    Toronto, Ontario, M4N 3M5

  • Novartis Investigative Site

    Vancouver, V5Z 4E6

Other trials in Canada

Switzerland10 sites

  • Novartis Investigative Site

    Aarau, 5001

  • Novartis Investigative Site

    Basel, 4031

  • Novartis Investigative Site

    Bellinzona, 6500

  • Novartis Investigative Site

    Chur, 7000

  • Novartis Investigative Site

    Lausanne, 1005

  • Novartis Investigative Site

    Locarno, 6600

  • Novartis Investigative Site

    Sankt Gallen, 9007

  • Novartis Investigative Site

    Thun, 3600

  • Novartis Investigative Site

    Zurich, 8008

  • Novartis Investigative Site

    Zurich, 8091

Other trials in Switzerland

Argentina9 sites

  • Novartis Investigative Site

    Berazategui, B1880BBF

  • Novartis Investigative Site

    Buenos Aires, C1125ABD

  • Novartis Investigative Site

    Buenos Aires, C1185AAT

  • Novartis Investigative Site

    Buenos Aires, C1417DTN

  • Novartis Investigative Site

    Mendoza, M5500AYB

  • Novartis Investigative Site

    Quilmes, 1878

  • Novartis Investigative Site

    Rosario, S2000KZE

  • Novartis Investigative Site

    San Miguel de Tucumán, 4000

  • Novartis Investigative Site

    Santa Fe, 3000

Other trials in Argentina

Chile8 sites

  • Novartis Investigative Site

    Santiago, 7500921

  • Novartis Investigative Site

    Santiago, 7650635

  • Novartis Investigative Site

    Santiago, 8360160

  • Novartis Investigative Site

    Santiago, 8380455

  • Novartis Investigative Site

    Temuco, 481-0469

  • Novartis Investigative Site

    Valdivia, 5090145

  • Novartis Investigative Site

    Valparaíso, 2341131

  • Novartis Investigative Site

    Viña del Mar, 254-0364

Other trials in Chile

India8 sites

  • Novartis Investigative Site

    Gūrgaon, 122002

  • Novartis Investigative Site

    Hyderabad, 500082

  • Novartis Investigative Site

    Kolkata, 700016

  • Novartis Investigative Site

    Mumbai, 400012

  • Novartis Investigative Site

    Nagpur, 440010

  • Novartis Investigative Site

    New Delhi, 110029

  • Novartis Investigative Site

    New Delhi, 110076

  • Novartis Investigative Site

    Trivandrum, 695011

Other trials in India

Israel8 sites

  • Novartis Investigative Site

    Beersheba, 84101

  • Novartis Investigative Site

    Haifa, 31096

  • Novartis Investigative Site

    Holon, 58100

  • Novartis Investigative Site

    Jerusalem, 91031

  • Novartis Investigative Site

    Netanya, 52621

  • Novartis Investigative Site

    Ramat Gan, 52621

  • Novartis Investigative Site

    Tel Aviv, 64239

  • Novartis Investigative Site

    Zrifin, 70300

Other trials in Israel

Taiwan8 sites

  • Novartis Investigative Site

    Kaohsiung City, 807

  • Novartis Investigative Site

    Taichung, 404

  • Novartis Investigative Site

    Tainan County, 736

  • Novartis Investigative Site

    Taipei, 100

  • Novartis Investigative Site

    Taipei, 104

  • Novartis Investigative Site

    Taipei, 105

  • Novartis Investigative Site

    Taipei, 112

  • Novartis Investigative Site

    Taipei, 114

Other trials in Taiwan

Ukraine8 sites

  • Novartis Investigative Site

    Chernivtsi, 58013

  • Novartis Investigative Site

    Donetsk, 83092

  • Novartis Investigative Site

    Kharkiv, 61024

  • Novartis Investigative Site

    Kyiv, 03115

  • Novartis Investigative Site

    Lviv, 79031

  • Novartis Investigative Site

    Simferopol, 95023

  • Novartis Investigative Site

    Uzhhorod, 88000

  • Novartis Investigative Site

    Uzhhorod, 88014

Other trials in Ukraine

Greece7 sites

  • Novartis Investigative Site

    Athens, 11522

  • Novartis Investigative Site

    Athens, 11527

  • Novartis Investigative Site

    Athens, 15123

  • Novartis Investigative Site

    Athens, 18547

  • Novartis Investigative Site

    Heraklion, 71110

  • Novartis Investigative Site

    Pátrai, 26504

  • Novartis Investigative Site

    Thessaloniki, 546 45

Other trials in Greece

South Africa7 sites

  • Novartis Investigative Site

    Capital Park, 0002

  • Novartis Investigative Site

    Groenkloof, 0081

  • Novartis Investigative Site

    Johannesburg, 2199

  • Novartis Investigative Site

    Observatory, 7925

  • Novartis Investigative Site

    Panorama, 7500

  • Novartis Investigative Site

    Parktown, 2193

  • Novartis Investigative Site

    Pretoria, 0081

Other trials in South Africa

South Korea7 sites

  • Novartis Investigative Site

    Gyeonggi-do, 10408

  • Novartis Investigative Site

    Gyeonggi-do, 443-380

  • Novartis Investigative Site

    Incheon, 400-711

  • Novartis Investigative Site

    Seoul, 003722

  • Novartis Investigative Site

    Seoul, 03080

  • Novartis Investigative Site

    Seoul, 06351

  • Novartis Investigative Site

    Seoul, 138-736

Other trials in South Korea

Thailand7 sites

  • Novartis Investigative Site

    Bangkok, 10330

  • Novartis Investigative Site

    Bangkok, 10400

  • Novartis Investigative Site

    Bangkok, 10700

  • Novartis Investigative Site

    Chiang Mai, 50200

  • Novartis Investigative Site

    Khon Kaen, 40002

  • Novartis Investigative Site

    Phitsanulok, 65000

  • Novartis Investigative Site

    Songkhla, 90110

Other trials in Thailand

Hungary6 sites

  • Novartis Investigative Site

    Budapest, 1032

  • Novartis Investigative Site

    Budapest, 1082

  • Novartis Investigative Site

    Budapest, 1122

  • Novartis Investigative Site

    Budapest, 1145

  • Novartis Investigative Site

    Győr, 9023

  • Novartis Investigative Site

    Szeged, 6720

Other trials in Hungary

Ireland6 sites

  • Novartis Investigative Site

    Cork

  • Novartis Investigative Site

    Dublin, 24

  • Novartis Investigative Site

    Dublin, 7

  • Novartis Investigative Site

    Dublin, 8

  • Novartis Investigative Site

    Dublin, 9

  • Novartis Investigative Site

    Galway

Other trials in Ireland

Austria5 sites

  • Novartis Investigative Site

    Rankweil, 6830

  • Novartis Investigative Site

    Salzburg, 5020

  • Novartis Investigative Site

    Steyr, 4400

  • Novartis Investigative Site

    Vienna, 1090

  • Novartis Investigative Site

    Villach, 9500

Other trials in Austria

China5 sites

  • Novartis Investigative Site

    Beijing, 100021

  • Novartis Investigative Site

    Beijing, 100071

  • Novartis Investigative Site

    Guangzhou, 510060

  • Novartis Investigative Site

    Shanghai, 200032

  • Novartis Investigative Site

    Tianjin, 300060

Other trials in China

Pakistan5 sites

  • Novartis Investigative Site

    Karachi, 74800

  • Novartis Investigative Site

    Karachi

  • Novartis Investigative Site

    Lahore, 53400

  • Novartis Investigative Site

    Lahore, 54600

  • Novartis Investigative Site

    Rawalpindi, 1590

Other trials in Pakistan

Slovakia5 sites

  • Novartis Investigative Site

    Bratislava, 812 50

  • Novartis Investigative Site

    Bratislava, 833 10

  • Novartis Investigative Site

    Košice, 041 91

  • Novartis Investigative Site

    Poprad, 058 01

  • Novartis Investigative Site

    Žilina, 010 01

Other trials in Slovakia

Bulgaria4 sites

  • Novartis Investigative Site

    Shumen, 9700

  • Novartis Investigative Site

    Sofia, 1527

  • Novartis Investigative Site

    Sofia, 1756

  • Novartis Investigative Site

    Varna, 9010

Other trials in Bulgaria

Mexico4 sites

  • Novartis Investigative Site

    Chihuahua City, 31000

  • Novartis Investigative Site

    México, 11000

  • Novartis Investigative Site

    Mexico City, 14080

  • Novartis Investigative Site

    Toluca, 50080

Other trials in Mexico

Peru4 sites

  • Novartis Investigative Site

    Callao, Callao 2

  • Novartis Investigative Site

    Lima, 11

  • Novartis Investigative Site

    Lima, 13

  • Novartis Investigative Site

    Lima, 34

Other trials in Peru

Philippines4 sites

  • Novartis Investigative Site

    Cebu, 6000

  • Novartis Investigative Site

    Quezon City, 1102

  • Novartis Investigative Site

    Sampaloc, 1008

  • Novartis Investigative Site

    San Juan City, 1502

Other trials in Philippines

Romania4 sites

  • Novartis Investigative Site

    Bucharest, 022328

  • Novartis Investigative Site

    Bucharest, 050098

  • Novartis Investigative Site

    Cluj-Napoca, 400015

  • Novartis Investigative Site

    Iași, 700106

Other trials in Romania

New Zealand3 sites

  • Novartis Investigative Site

    Hamilton, 2001

  • Novartis Investigative Site

    Palmerston North, 4414

  • Novartis Investigative Site

    Wellington, 6021

Other trials in New Zealand

Norway3 sites

  • Novartis Investigative Site

    Oslo, 0310

  • Novartis Investigative Site

    Oslo, 0407

  • Novartis Investigative Site

    Tromsø, 9038

Other trials in Norway

Estonia2 sites

  • Novartis Investigative Site

    Tallinn, 13419

  • Novartis Investigative Site

    Tartu, 51014

Other trials in Estonia

Hong Kong2 sites

  • Novartis Investigative Site

    Kowloon

  • Novartis Investigative Site

    Tuenmen

Other trials in Hong Kong

Singapore1 site

  • Novartis Investigative Site

    Singapore, 119082

Other trials in Singapore

Slovenia1 site

  • Novartis Investigative Site

    Ljubljana, 1000

Other trials in Slovenia

About this study

Official title: A Randomised, Multi-centre, Open-label, Phase III Study of Adjuvant Lapatinib, Trastuzumab, Their Sequence and Their Combination in Patients With HER2/ErbB2 Positive Primary Breast Cancer

This was a four-arm (parallel group) randomized, open-label, multicenter Phase 3 study to investigate the use of a combination of Lapatinib and Trastuzumab, a sequence of Trastuzumab followed by Lapatinib, and Lapatinib alone, compared to Trastuzumab alone in the adjuvant treatment of Human Epidermal Growth Factor Receptor 2 (HER2) positive early breast cancer.

Read the detailed description

Treatment allocation was stratified by blocked randomization, with three stratification factors:

  • Hormone receptor status: Estrogen Receptor (ER) and/or Progesterone Receptor (PgR) positive versus both negative.
  • Axillary lymph node involvement: not assessed because of neoadjuvant chemotherapy versus node negative versus 1-3 positive nodes versus 4 or more positive nodes.
  • Timing of adjuvant chemotherapy: concurrently with taxanes and targeted therapy (Design 2) and concurrently with non-anthracycline-based platinum chemotherapy and targeted therapy (Design 2B) versus all other chemotherapy completed before randomization (Design 1). Treatments delivered differed according to the timing and type of adjuvant chemotherapy.

The primary objective of this study was to compare disease-free survival (DFS) in subjects with HER2 overexpressing and/or amplified breast cancer randomized to trastuzumab for one year versus lapatinib for one year versus trastuzumab (12 or 18 weeks, according to assigned design) followed by a six week treatment-free interval followed by lapatinib (28 or 34 weeks, according to assigned design) versus trastuzumab in combination with lapatinib for one year (52 weeks).

Secondary objectives included treatment comparisons with respect to overall survival, time to recurrence, time to distant recurrence, safety and tolerability, and incidence of brain metastasis.

Based on the recommendation of the Independent Data Monitoring Committee (IDMC) at the first interim analysis (18-Aug-2011), the Lapatinib alone arm was discontinued prior to primary analysis due to futility. The IDMC also stated that the other three arms (trastuzumab alone, sequential trastuzumab/lapatinib arm and the combination arm) could continued as planned with no changes.

Being tested
Lapatinib, Trastuzumab
Keywords
Adjuvant, ErbB2-overexpressing, Early stage breast cancer, HER2/neu gene amplified
Medical subject headings
Breast Neoplasms

What participants receive

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

  • LapatinibDrug

    Also called GW572016

    Small molecule inhibitor

  • TrastuzumabBiological

    Antibody

Study groups in NCT00490139
Study groupRoleWhat they receive
Lapatinib plus TrastuzumabExperimentalDesign 1: Oral lapatinib 1000 mg daily concurrent with trastuzumab 8 mg/kg IV loading dose followed by 6mg/kg IV every 3 weeks (52 weeks total). Design 2: Trastuzumab (4mg/kg loading dose followed by 2mg/kg IV weekly) concurrent with oral lapatinib 750 mg daily and either paclitaxel 80mg/m2 IV weekly for 12 weeks OR docetaxel 75mg/m2 every 21 days for 4 cycles (12 weeks). After completion of chemotherapy, the dose of lapatinib will be increased to 1000mg daily concurrently with trastuzumab every 3 weeks (6mg/kg without loading dose) for an additional 40 weeks (52 weeks total). Design 2B: Docetaxel 75mg/m2 and carboplatin AUC 6 every 3 weeks for 6 cycles (18 weeks) administered concurrently with oral lapatinib 750mg plus weekly trastuzumab (4mg/kg IV loading dose followed by 2mg/kg IV. After the completion of chemotherapy, trastuzumab will be administered every 3 weeks (6mg/kg without loading dose) concurrent with lapatinib 1000mg daily for an additional 40 weeks (52 weeks total).
Receives: Drug: Lapatinib; Biological: Trastuzumab
Trastuzumab followed by LapatinibExperimentalDesign 1: Trastuzumab (4mg/kg IV loading dose followed by 2mg/kg IV weekly) for 12 weeks followed by a 6 week treatment-free interval followed by oral lapatinib 1500mg daily for 34 weeks (52 weeks total). Design 2: Trastuzumab (4mg/kg IV loading dose followed by 2mg/kg IV weekly) for 12 weeks administered concomitantly and either paclitaxel 80mg/m2 IV weekly for 12 weeks OR docetaxel 75mg/m2 every 21 days for 4 cycles; followed by a 6 week treatment-free interval followed by oral lapatinib 1500mg daily for 34 weeks (52 weeks total). Design 2B: Docetaxel 75mg/m2 and carboplatin AUC 6 every 3 weeks for 6 cycles (18 weeks) administered concomitantly with trastuzumab (4mg/kg IV loading dose followed by 2mg/kg IV weekly) followed by a 6 week treatment-free interval followed by oral lapatinib 1500 mg daily for 28 weeks (52 weeks total).
Receives: Drug: Lapatinib; Biological: Trastuzumab
LapatinibExperimentalDesign 1: Lapatinib 1500mg oral daily for a total of 52 weeks. Design 2: Either paclitaxel 80mg/m2 IV weekly for 12 weeks OR docetaxel 75mg/m2 IV every 3 weeks for 4 cycles administered concomitantly with oral lapatinib at 750mg daily. After completion of chemotherapy, oral lapatinib administered at 1500mg daily for an additional 40 weeks (52 weeks total). Design 2B: Docetaxel 75mg/m2 and carboplatin AUC 6 every 3 weeks for 6 cycles (18 weeks) administered concomitantly with oral lapatinib at 750mg daily. After completion of chemotherapy, the dose of lapatinib will be increased to 1500mg oral daily for an additional 40 weeks (52 weeks total).
Receives: Drug: Lapatinib
TrastuzumabActive comparatorDesign 1: Trastuzumab 8mg/kg IV loading dose followed by 6mg/kg IV every 3 weeks for a total of 52 weeks. Design 2: Either paclitaxel 80mg/m2 IV weekly for 12 weeks OR docetaxel 75mg/m2 IV every 3 weeks for 4 cycles administered concomitantly with trastuzumab 4mg/kg IV loading dose followed by 2mg/kg IV weekly. After completion of chemotherapy, trastuzumab administered every 3 weeks (6mg/kg IV without loading dose) for an additional 40 weeks (52 weeks total). Design 2B: Docetaxel 75mg/m2 and carboplatin AUC 6 every 3 weeks for 6 cycles (18 weeks) administered concomitantly with trastuzumab 4mg/kg IV loading dose followed by 2mg/kg IV weekly. After completion of chemotherapy, trastuzumab (6mg/kg without loading dose) every 3 weeks for an additional 40 weeks (52 weeks total).
Receives: Biological: Trastuzumab

What is being measured

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

  1. Disease-Free Survival (DFS) at the Primary Analysis

    Disease-Free Survival (DFS) was defined as the interval between randomization and the date of first occurrence of disease recurrence (local, regional or distant), a contralateral invasive breast cancer, a second primary cancer or death without recurrence. Only deaths occurring in participants whose clinical follow-up was ongoing at the time of death and who had no recurrence, contralateral breast cancer (CBC) or second primary malignancy (SPM) reported prior to death were considered as death without recurrence. DFS was estimated using the Kaplan Meier method. The percentile data values presented here indicate the percentage (95, 90, 85, 80 and 75 percent) of participants who had disease free survival for the indicated years.

    Measured: From randomization until the date of the first occurrence of disease recurrence, a contralateral invasive breast cancer, a second primary cancer, or death from any cause (median follow-up of 4.5 years)

Secondary outcomes (7)

  1. Disease-Free Survival (DFS) at the 10-Year Follow-Up

    Disease-Free Survival (DFS) was defined as the interval between randomization and the date of first occurrence of disease recurrence (local, regional or distant), a contralateral invasive breast cancer, a second primary cancer or death without recurrence. Only deaths occurring in participants whose clinical follow-up was ongoing at the time of death and who had no recurrence, contralateral breast cancer (CBC) or second primary malignancy (SPM) reported prior to death were considered as death without recurrence. DFS was estimated using the Kaplan Meier method. The percentile data values presented here indicate the percentage (95, 90, 85 and 80 percent) of participants who had disease free survival for the indicated years.

    Measured: From randomization until the date of the first occurrence of disease recurrence, a contralateral invasive breast cancer, a second primary cancer, or death from any cause, assessed up to approximately 10 years

  2. Overall Survival (OS) at the Primary Analysis

    Overall Survival (OS) was defined as the time from randomization until death due to any cause. Participants who had not died were censored at the last date they were known to be alive, or date of withdrawal of consent. OS was calculated in years as (date of death minus the date of randomization +1) divided by 365.25. The percentile data values presented here indicate the percentage (99, 98, 97, 96, 95 and 90 percent) of participants who survived for the indicated years.

    Measured: From randomization until death due to any cause (median follow-up of 4.5 years)

  3. Overall Survival (OS) at the 10-Year Follow-Up

    Overall Survival (OS) was defined as the time from randomization until death due to any cause. Participants who had not died were censored at the last date they were known to be alive, or date of withdrawal of consent. OS was calculated in years as (date of death minus the date of randomization +1) divided by 365.25. The percentile data values presented here indicate the percentage (99, 98, 95 and 90 percent) of participants who survived for the indicated years.

    Measured: From randomization until death due to any cause, assessed up to approximately 10 years

  4. Analysis of Time to Recurrence (TTR)

    Time to Recurrence (TTR) was defined as the the time from randomization to breast cancer recurrence, ignoring second primary cancers (including contralateral breast cancers and non-breast second malignancies) and counting deaths without recurrence as a competing risk.

    Measured: From randomization until the date of the first occurrence of a disease recurrence, assessed up to approximately 10 years

  5. Analysis of Time to Distant Recurrence (TTDR)

    Time to Distant Recurrence (TTDR) was defined as the the time from randomization to first distant breast cancer recurrence, ignoring locoregional recurrences and second primary cancers, (including contralateral breast cancers and non-breast second malignancies ) and counting deaths without recurrence as a competing risk.

    Measured: From randomization until the date of the first occurrence of distant recurrence, assessed up to approximately 10 years

  6. Analysis of Time to Central Nervous System (CNS) Recurrence

    Time to Central Nervous System (CNS) recurrence was defined as the time from randomization to first CNS recurrence. Both brain metastasis and meningitis carcinomatosa were considered.

    Measured: From randomization until the first central nervous system recurrence, assessed up to approximately 10 years

  7. Cumulative Incidence of Brain Metastases

    The cumulative incidence of brain metastases as the first site of breast cancer recurrence among treatment arms was assessed using a hierarchy of primary type and location of first DFS event in cases where more than one event was identified simultaneously. Because diagnostic procedures for different types of recurrence could not be performed on exactly the same day, any diagnoses noted within a two month (60 day) period of the first reported event was considered as identified simultaneously for purposes of defining the type of the first event and the date of event was be regarded as the earliest of the relevant events.

    Measured: From randomization until the date of the first occurrence of a disease recurrence, assessed up to approximately 10 years

Timeline

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

  1. First posted22 Jun 2007 (estimated)
  2. Study start16 May 2007
  3. Primary completion6 Dec 2013
  4. Study completion1 Jul 2021

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
8,381 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00490139
Sponsor's protocol ID
EGF106708
Other IDs
CLAP016B2301, 2006-000562-36
Acronym
ALTTO
Status last verified
Mar 2025
First submitted
20 Jun 2007
Last updated
21 Mar 2025
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations. This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com

Publications

  • Rediti M, Venet D, Joaquin Garcia A, Maetens M, Vincent D, Majjaj S, El-Abed S, Di Cosimo S, Ueno T, Izquierdo M, Piccart M, Pusztai L, Loi S, Salgado R, Viale G, Rothe F, Sotiriou C. Identification of HER2-positive breast cancer molecular subtypes with potential clinical implications in the ALTTO clinical trial. Nat Commun. 2024 Nov 29;15(1):10402. doi: 10.1038/s41467-024-54621-3.

    PubMed 39613746

  • de Azambuja E, Piccart-Gebhart M, Fielding S, Townend J, Hillman DW, Colleoni M, Roylance R, Kelly CM, Lombard J, El-Abed S, Choudhury A, Korde L, Vicente M, Chumsri S, Rodeheffer R, Ellard SL, Wolff AC, Holtschmidt J, Lang I, Untch M, Boyle F, Xu B, Werutsky G, Tujakowski J, Huang CS, Baruch NB, Bliss J, Ferro A, Gralow J, Kim SB, Kroep JR, Krop I, Kuemmel S, McConnell R, Moscetti L, Knop AS, van Duijnhoven F, Gomez H, Cameron D, Di Cosimo S, Gelber RD, Moreno-Aspitia A. Final analysis of the ALTTO trial: adjuvant trastuzumab in sequence or in combination with lapatinib in patients with HER2-positive early breast cancer [BIG 2-06/NCCTG N063D (Alliance)]. ESMO Open. 2024 Nov;9(11):103938. doi: 10.1016/j.esmoop.2024.103938. Epub 2024 Oct 17.

    PubMed 39418883

  • Nader-Marta G, Debien V, Eiger D, Tsourti Z, Caparica R, Kassapian M, Napoleone S, Hultsch S, Korde L, Wang Y, Chumsri S, Pritchard KI, Untch M, Bellet-Ezquerra M, Dornelles Rosa D, Moreno-Aspitia A, Piccart M, Dafni U, de Azambuja E. Outcomes of patients with small and node-negative HER2-positive early breast cancer treated with adjuvant chemotherapy and anti-HER2 therapy-a sub-analysis of the ALTTO study. Br J Cancer. 2022 Nov;127(10):1799-1807. doi: 10.1038/s41416-022-01963-8. Epub 2022 Sep 1.

    PubMed 36050448

  • Moreno-Aspitia A, Holmes EM, Jackisch C, de Azambuja E, Boyle F, Hillman DW, Korde L, Fumagalli D, Izquierdo MA, McCullough AE, Wolff AC, Pritchard KI, Untch M, Guillaume S, Ewer MS, Shao Z, Sim SH, Aziz Z, Demetriou G, Mehta AO, Andersson M, Toi M, Lang I, Xu B, Smith IE, Barrios CH, Baselga J, Gelber RD, Piccart-Gebhart M; ALTTO Steering Committee and Investigators. Updated results from the international phase III ALTTO trial (BIG 2-06/Alliance N063D). Eur J Cancer. 2021 May;148:287-296. doi: 10.1016/j.ejca.2021.01.053. Epub 2021 Mar 23.

    PubMed 33765513

  • Sonnenblick A, Agbor-Tarh D, de Azambuja E, Hultsch S, Izquierdo M, Liu M, Pruneri G, Harbeck N, Piccart M, Moreno-Aspita A, Granit RZ, Rouas G, Fahoum I, Sotiriou C. STAT3 activation in HER2-positive breast cancers: Analysis of data from a large prospective trial. Int J Cancer. 2021 Mar 15;148(6):1529-1535. doi: 10.1002/ijc.33385. Epub 2020 Nov 23.

    PubMed 33152119

  • Eiger D, Ponde NF, Agbor-Tarh D, Moreno-Aspitia A, Piccart M, Hilbers FS, Werner O, Chumsri S, Dueck A, Kroep JR, Gomez H, Lang I, Rodeheffer RJ, Ewer MS, Suter T, de Azambuja E. Long-term cardiac outcomes of patients with HER2-positive breast cancer treated in the adjuvant lapatinib and/or trastuzumab Treatment Optimization Trial. Br J Cancer. 2020 May;122(10):1453-1460. doi: 10.1038/s41416-020-0786-x. Epub 2020 Mar 16.

    PubMed 32203207

  • Holmes EM, Bradbury I, Williams LS, Korde L, de Azambuja E, Fumagalli D, Moreno-Aspitia A, Baselga J, Piccart-Gebhart M, Dueck AC, Gelber RD; ALTTO Trial Study Team. Are we assuming too much with our statistical assumptions? Lessons learned from the ALTTO trial. Ann Oncol. 2019 Sep 1;30(9):1507-1513. doi: 10.1093/annonc/mdz195.

    PubMed 31240310

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Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Lapatinib and Trastuzumab in people with Neoplasms, Breast, run by Novartis Pharmaceuticals at 924 sites in 44 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 3 inclusion and 16 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 21 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 924 sites in United States, Germany, France, United Kingdom, Italy and 39 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 18 Aug 2014). 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?

Disease-Free Survival (DFS) at the Primary Analysis (time frame: From randomization until the date of the first occurrence of disease recurrence, a contralateral invasive breast cancer, a second primary cancer, or death from any cause (median follow-up of 4.5 years)). 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 NCT00490139, which also lists 8 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 21 Mar 2025.

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