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Completed Phase 3 Interventional Results available

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

ClinicalTrials.gov ID: NCT00490139

Public ClinicalTrials.gov record NCT00490139. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Sep 27, 2026, 11:27 PM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

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

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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.

Study identification

NCT ID
NCT00490139
Recruitment status
Completed
Study type
Interventional
Phase
Phase 3
Lead sponsor
Novartis Pharmaceuticals
Industry
Enrollment
8,381 participants

Conditions and interventions

Interventions

Drug · Biological

Eligibility (public fields only)

Age range
18 Years and older
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
May 15, 2007
Primary completion
Dec 5, 2013
Completion
Jun 30, 2021
Last update posted
Mar 20, 2025

2007 – 2021

United States locations

U.S. sites
260
U.S. states
48
U.S. cities
224
Facility City State ZIP Site status
Novartis Investigative Site Mobile Alabama 36608 —
Novartis Investigative Site Anchorage Alaska 99508 —
Novartis Investigative Site Tucson Arizona 85715 —
Novartis Investigative Site Jonesboro Arkansas 72401 —
Novartis Investigative Site Duarte California 91010 —
Novartis Investigative Site Fairfield California 94533 —
Novartis Investigative Site La Jolla California 92093-0987 —
Novartis Investigative Site La Jolla California 92093 —
Novartis Investigative Site Loma Linda California 92534 —
Novartis Investigative Site Martinez California 94553-3156 —
Novartis Investigative Site Marysville California 95901 —
Novartis Investigative Site Mountain View California 94040 —
Novartis Investigative Site Oakland California 94609 —
Novartis Investigative Site Pleasanton California 94588 —
Novartis Investigative Site Sacramento California 95817 —
Novartis Investigative Site San Francisco California 94110 —
Novartis Investigative Site Aurora Colorado 80012 —
Novartis Investigative Site Boulder Colorado 80301 —
Novartis Investigative Site Colorado Springs Colorado 80907 —
Novartis Investigative Site Denver Colorado 80210 —
Novartis Investigative Site Denver Colorado 80218 —
Novartis Investigative Site Denver Colorado 80220 —
Novartis Investigative Site Fort Collins Colorado 80524 —
Novartis Investigative Site Fort Collins Colorado 80528 —
Novartis Investigative Site Thornton Colorado 80229 —
Novartis Investigative Site Wheat Ridge Colorado 80033 —
Novartis Investigative Site Hartford Connecticut 06105 —
Novartis Investigative Site New Haven Connecticut 06520 —
Novartis Investigative Site Dover Delaware 19901 —
Novartis Investigative Site Washington D.C. District of Columbia 20007 —
Novartis Investigative Site Washington D.C. District of Columbia 20307 —
Novartis Investigative Site Boca Raton Florida 33486 —
Novartis Investigative Site Fort Lauderdale Florida 33308 —
Novartis Investigative Site Fort Myers Florida 33916 —
Novartis Investigative Site Hollywood Florida 33021 —
Novartis Investigative Site Jacksonville Florida 32207 —
Novartis Investigative Site Jacksonville Florida 32224 —
Novartis Investigative Site Lakeland Florida 33805 —
Novartis Investigative Site Ocala Florida 34474 —
Novartis Investigative Site Orlando Florida 32803 —
Novartis Investigative Site Orlando Florida 32806 —
Novartis Investigative Site Weston Florida 33331 —
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 Columbus Georgia 31904 —
Novartis Investigative Site Decatur Georgia 30033 —
Novartis Investigative Site Savannah Georgia 31405 —
Novartis Investigative Site Honolulu Hawaii 96813 —
Novartis Investigative Site Honolulu Hawaii 96859 —
Novartis Investigative Site Lihue Hawaii 96766 —
Novartis Investigative Site Boise Idaho 83706 —
Novartis Investigative Site Boise Idaho 83712 —
Novartis Investigative Site Chicago Illinois 60611 —
Novartis Investigative Site Evanston Illinois 60201 —
Novartis Investigative Site Harvey Illinois 60426 —
Novartis Investigative Site Kankakee Illinois 60901 —
Novartis Investigative Site Maywood Illinois 60153 —
Novartis Investigative Site Mount Vernon Illinois 62864 —
Novartis Investigative Site Oak Lawn Illinois 60453-2699 —
Novartis Investigative Site Ottawa Illinois 61350 —
Novartis Investigative Site Pekin Illinois 61554 —
Novartis Investigative Site Peoria Illinois 61615 —
Novartis Investigative Site Peru Illinois 61354 —
Novartis Investigative Site Princeton Illinois 61356 —
Novartis Investigative Site Rockford Illinois 61104 —
Novartis Investigative Site Rockford Illinois 61114 —
Novartis Investigative Site Skokie Illinois 60077 —
Novartis Investigative Site Springfield Illinois 62781-0001 —
Novartis Investigative Site Urbana Illinois 61801 —
Novartis Investigative Site Beech Grove Indiana 46107 —
Novartis Investigative Site Fort Wayne Indiana 46815 —
Novartis Investigative Site Indianapolis Indiana 46202 —
Novartis Investigative Site Kokomo Indiana 46904 —
Novartis Investigative Site Mishawaka Indiana 46545 —
Novartis Investigative Site Muncie Indiana 47303 —
Novartis Investigative Site South Bend Indiana 46601 —
Novartis Investigative Site South Bend Indiana 46617 —
Novartis Investigative Site Ames Iowa 50010 —
Novartis Investigative Site Bettendorf Iowa 52722 —
Novartis Investigative Site Cedar Rapids Iowa 52402 —
Novartis Investigative Site Des Moines Iowa 50309 —
Novartis Investigative Site Des Moines Iowa 50314 —
Novartis Investigative Site Mason City Iowa — —
Novartis Investigative Site Sioux City Iowa 51101-1733 —
Novartis Investigative Site Waterloo Iowa 50702 —
Novartis Investigative Site Chanute Kansas 66720 —
Novartis Investigative Site El Dorado Kansas 67042 —
Novartis Investigative Site Independence Kansas 67301 —
Novartis Investigative Site Lawrence Kansas 66044 —
Novartis Investigative Site Prairie Village Kansas 66208 —
Novartis Investigative Site Pratt Kansas 67124 —
Novartis Investigative Site Topeka Kansas 66604 —
Novartis Investigative Site Topeka Kansas 66606 —
Novartis Investigative Site Wichita Kansas 67214 —
Novartis Investigative Site Louisville Kentucky 40292 —
Novartis Investigative Site Baton Rouge Louisiana 70809 —
Novartis Investigative Site New Orleans Louisiana 70112 —
Novartis Investigative Site New Orleans Louisiana 70121 —
Novartis Investigative Site Portland Maine 04101 —
Novartis Investigative Site Scarborough Maine 04074 —
Novartis Investigative Site Baltimore Maryland 21201 —
Novartis Investigative Site Baltimore Maryland 21287-8936 —
Novartis Investigative Site Bethesda Maryland 20889-5600 —
Novartis Investigative Site Frederick Maryland 21701 —
Novartis Investigative Site Silver Spring Maryland 20910 —
Novartis Investigative Site Towson Maryland 21204 —
Novartis Investigative Site Westminster Maryland 21157 —
Novartis Investigative Site Boston Massachusetts 02135 —
Novartis Investigative Site Hyannis Massachusetts 02601 —
Novartis Investigative Site Peabody Massachusetts 01960 —
Novartis Investigative Site Adrian Michigan 49221 —
Novartis Investigative Site Ann Arbor Michigan 48106-0995 —
Novartis Investigative Site Dearborn Michigan 48123 —
Novartis Investigative Site Detroit Michigan 48202 —
Novartis Investigative Site Flint Michigan 48532 —
Novartis Investigative Site Iron Mountain Michigan 49801 —
Novartis Investigative Site Kalamazoo Michigan 49007 —
Novartis Investigative Site Pontiac Michigan 48341-2985 —
Novartis Investigative Site Saginaw Michigan 48601 —
Novartis Investigative Site Saint Joseph Michigan 49085 —
Novartis Investigative Site Southfield Michigan 48075 —
Novartis Investigative Site Albert Lea Minnesota 56007 —
Novartis Investigative Site Duluth Minnesota 55805 —
Novartis Investigative Site Edina Minnesota 55435 —
Novartis Investigative Site Mankato Minnesota 56002 —
Novartis Investigative Site Maplewood Minnesota 55109 —
Novartis Investigative Site Minneapolis Minnesota 55407-3799 —
Novartis Investigative Site Minneapolis Minnesota 55415 —
Novartis Investigative Site Saint Cloud Minnesota 56303 —
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 Shakopee Minnesota 55379 —
Novartis Investigative Site Waconia Minnesota 55387 —
Novartis Investigative Site Willmar Minnesota 56201 —
Novartis Investigative Site Pascagoula Mississippi 39581 —
Novartis Investigative Site Kansas City Missouri 64131 —
Novartis Investigative Site Springfield Missouri 65807 —
Novartis Investigative Site St Louis Missouri 63110 —
Novartis Investigative Site Billings Montana 59101 —
Novartis Investigative Site Bozeman Montana 59715 —
Novartis Investigative Site Great Falls Montana 59405 —
Novartis Investigative Site Grand Island Nebraska 68803 —
Novartis Investigative Site Lincoln Nebraska 68510 —
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 Las Vegas Nevada 89169 —
Novartis Investigative Site Concord New Hampshire 03301 —
Novartis Investigative Site Hooksett New Hampshire 03106 —
Novartis Investigative Site Laconia New Hampshire 03246 —
Novartis Investigative Site Lebanon New Hampshire 03756 —
Novartis Investigative Site Hackensack New Jersey 07601 —
Novartis Investigative Site Livingston New Jersey 07039 —
Novartis Investigative Site New Brunswick New Jersey 08901 —
Novartis Investigative Site Princeton New Jersey 24740 —
Novartis Investigative Site Somerville New Jersey 08876 —
Novartis Investigative Site Sparta New Jersey 07871 —
Novartis Investigative Site Vineland New Jersey 08360 —
Novartis Investigative Site Albuquerque New Mexico 87106 —
Novartis Investigative Site Albuquerque New Mexico 87110 —
Novartis Investigative Site Las Cruces New Mexico 88011 —
Novartis Investigative Site Buffalo New York 14263 —
Novartis Investigative Site Cooperstown New York 13326 —
Novartis Investigative Site East Syracuse New York 13057 —
Novartis Investigative Site Manhasset New York 11030 —
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 Rochester New York 14642 —
Novartis Investigative Site The Bronx New York 10461 —
Novartis Investigative Site The Bronx New York 10467-2490 —
Novartis Investigative Site Chapel Hill North Carolina 27599 —
Novartis Investigative Site Hendersonville North Carolina 28791 —
Novartis Investigative Site Kinston North Carolina 28501 —
Novartis Investigative Site Raleigh North Carolina 27607 —
Novartis Investigative Site Washington North Carolina 27889 —
Novartis Investigative Site Winston-Salem North Carolina 27157 —
Novartis Investigative Site Bismarck North Dakota 58501 —
Novartis Investigative Site Fargo North Dakota 58122 —
Novartis Investigative Site Minot North Dakota 58701 —
Novartis Investigative Site Bowling Green Ohio 43402 —
Novartis Investigative Site Canton Ohio 44710 —
Novartis Investigative Site Chillicothe Ohio 54601 —
Novartis Investigative Site Cincinnati Ohio 45242 —
Novartis Investigative Site Clyde Ohio 43410 —
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 Dayton Ohio 45415 —
Novartis Investigative Site Franklin Ohio 45005-1066 —
Novartis Investigative Site Greenville Ohio 45331 —
Novartis Investigative Site Kettering Ohio 45429 —
Novartis Investigative Site Maumee Ohio 43623 —
Novartis Investigative Site Sandusky Ohio 44870 —
Novartis Investigative Site Sylvania Ohio 43560 —
Novartis Investigative Site Toledo Ohio 43623 —
Novartis Investigative Site Oklahoma City Oklahoma 73120 —
Novartis Investigative Site Tulsa Oklahoma 74136 —
Novartis Investigative Site Eugene Oregon 97401 —
Novartis Investigative Site Portland Oregon 97210 —
Novartis Investigative Site Abington Pennsylvania 19001-3788 —
Novartis Investigative Site Bethlehem Pennsylvania 18015 —
Novartis Investigative Site Hershey Pennsylvania 17033 —
Novartis Investigative Site Kingston Pennsylvania 18704 —
Novartis Investigative Site Nashville Pennsylvania 37204 —
Novartis Investigative Site Philadelphia Pennsylvania 19111 —
Novartis Investigative Site Pottstown Pennsylvania 19464 —
Novartis Investigative Site Sayre Pennsylvania 18840 —
Novartis Investigative Site West Reading Pennsylvania 19611 —
Novartis Investigative Site Charleston South Carolina 29406 —
Novartis Investigative Site Greenville South Carolina 29605 —
Novartis Investigative Site Rapid City South Dakota 57701 —
Novartis Investigative Site Chattanooga Tennessee 37403 —
Novartis Investigative Site Chattanooga Tennessee 37404 —
Novartis Investigative Site Jackson Tennessee 38301 —
Novartis Investigative Site Knoxville Tennessee 37920 —
Novartis Investigative Site Memphis Tennessee 38120 —
Novartis Investigative Site Nashville Tennessee 37203 —
Novartis Investigative Site Nashville Tennessee 37208 —
Novartis Investigative Site Nashville Tennessee 37232 —
Novartis Investigative Site Beaumont Texas 77702-1449 —
Novartis Investigative Site Bedford Texas 76022 —
Novartis Investigative Site Fort Sam Houston Texas 78234 —
Novartis Investigative Site Fort Worth Texas 76104 —
Novartis Investigative Site Houston Texas 77030 —
Novartis Investigative Site Lackland Air Force Base Texas 78236 —
Novartis Investigative Site Longview Texas 75601 —
Novartis Investigative Site McAllen Texas 78503-1298 —
Novartis Investigative Site Mesquite Texas 75150 —
Novartis Investigative Site Midland Texas 79701 —
Novartis Investigative Site San Antonio Texas 78209 —
Novartis Investigative Site San Antonio Texas 78229 —
Novartis Investigative Site Tyler Texas 75702 —
Novartis Investigative Site Salt Lake City Utah 84112 —
Novartis Investigative Site Hampton Virginia 23666 —
Novartis Investigative Site Richmond Virginia 23230 —
Novartis Investigative Site Roanoke Virginia 24014 —
Novartis Investigative Site Bellingham Washington 98225 —
Novartis Investigative Site Seattle Washington 98122 —
Novartis Investigative Site Seattle Washington 98133 —
Novartis Investigative Site Spokane Washington 99218 —
Novartis Investigative Site Tacoma Washington 98405 —
Novartis Investigative Site Charleston West Virginia 25304 —
Novartis Investigative Site Huntington West Virginia 25701 —
Novartis Investigative Site Appleton Wisconsin 53715 —
Novartis Investigative Site Chippewa Falls Wisconsin 54729 —
Novartis Investigative Site Eau Claire Wisconsin 54702 —
Novartis Investigative Site Green Bay Wisconsin 54301 —
Novartis Investigative Site La Crosse Wisconsin 54601 —
Novartis Investigative Site Madison Wisconsin 53717 —
Novartis Investigative Site Oshkosh Wisconsin 54904 —
Novartis Investigative Site Sturgeon Bay Wisconsin 54235 —

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 664 non-U.S. sites.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT00490139, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Mar 20, 2025 · Synced Sep 27, 2026

Related: full search, browse by condition, browse by drug or therapy, browse by sponsor, browse by U.S. city.

Open the official record

The complete protocol, eligibility criteria, and contact information for NCT00490139 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →