AzTrials
AzTrials

Neoplasms, BreastPhase 3NCT00374322

Tykerb Evaluation After Chemotherapy (TEACH): Lapatinib Versus Placebo In Women With Early-Stage Breast Cancer

A Phase 3 study testing lapatinib in people with Neoplasms, Breast, run by GlaxoSmithKline at 439 sites in 33 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 study was designed to evaluate and compare the safety and efficacy of an oral dual tyrosine kinase inhibitor, lapatinib, versus placebo in women with early-stage ErbB2-overexpressing breast cancer who have completed their primary neoadjuvant or adjuvant chemotherapy and have no clinical or radiographic evidence… Read more about this study

Who is it for?
Ages 18 years and older, women only
Conditions the study is for
Neoplasms, Breast
What is being tested?
lapatinib
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
3,166 participants
Where
439 sitesin 33 countries
Study dates
Aug 2006to Jul 2013
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
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Have histologically or cytologically confirmed ErbB2-overexpressing invasive carcinoma (TX or T1-4) of the breast at the time of the initial diagnosis and have undergone adequate excision of tumor;
  • Had tumors that overexpress ErbB2 defined as 3+ by IHC or c-erbB2 gene amplification by FISH (ErbB2 expression/amplification must be documented prior to study entry; however, a tumor tissue sample must be sent to a central laboratory for subsequent re-analysis of ErbB2 status);
  • Have Stage I through Stage IIIc disease according to the American Joint Committee on Cancer (6th edition) staging criteria for breast cancer and meet one of the following criteria:
  • node-positive disease defined as: one positive lymph node by sentinel node biopsy OR at least 1 positive lymph node found among at least 6 axillary nodes examined on axillary node dissection OR status post axillary radiotherapy for sterilization if clinically evaluated as cN1 or cN2 (if sentinel node biopsy is positive, subject may either undergo an axillary node dissection or radiotherapy to the axilla).
  • node-positive disease evaluated as: ipsilateral axillary lymph nodes cN0-2 by clinical evaluation and axillary lymph nodes pNX, pN0(i+), or pN1-3 by pathological evaluation [patients with pN3 (Stage IIIc disease) must be disease free following completion of neoadjuvant or adjuvant chemotherapy for at least 12 months and must not have been lost to follow up].
  • OR node-negative disease defined as: negative sentinel node biopsy OR no positive lymph nodes found among at least 6 axillary nodes examined on axillary node dissection OR status post axillary radiotherapy for sterilization if clinically evaluated as cN0.
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  • node-negative disease categorized as: high-risk disease (tumor >2.0 cm if ER and/or progesterone receptor (PgR) positive disease is present or tumor >1.0 cm if ER and PgR negative disease) OR intermediate-risk disease (tumor 1.0-2.0 cm and ER and/or PgR positive disease).
  • Women with synchronous bilateral invasive breast cancer or synchronous DCIS of either the contralateral or ipsilateral breast at the time of the initial diagnosis are also eligible;
  • Have undergone either mastectomy OR lumpectomy;
  • Have received and completed treatment with a neoadjuvant or adjuvant chemotherapy regimen containing either an anthracycline or a taxane; or any cyclophosphamide, methotrexate and 5-fluorouracil (CMF) regimen;
  • May continue to receive endocrine therapy while taking study medication, if endocrine therapy was initiated as either adjuvant therapy for treatment of the initial diagnosis of invasive breast cancer or for ovarian function suppression; however, endocrine therapy may not be initiated while taking study medication. Endocrine therapy agents may be switched while participating in this study (e.g., stop tamoxifen and start letrozole);
  • May have received prior radiotherapy as treatment for primary tumor; however, is not required for study entry;
  • May continue to receive radiotherapy while taking study medication, if radiotherapy was initiated as adjuvant therapy for treatment of the initial diagnosis of invasive breast cancer;
  • May continue to receive bisphosphonates only for treatment of documented osteoporosis, but not as treatment or prophylaxis of bone metastases;
  • All women eligible for adjuvant treatment with trastuzumab, including those diagnosed and treated within the last six months, must be considered for such treatment prior to being offered participation in this study. Participation in this study will be allowed only if the physician and patient have considered and discussed at length the advantages of trastuzumab, but have mutually decided against initiating trastuzumab therapy.
  • Have clinical and radiologic assessments that are negative for local or regional recurrence of disease or metastatic disease at the time of study entry;
  • if signs or symptoms suggestive of either recurrence of disease or metastatic disease are present, the appropriate radiological imaging must be performed
  • if the following laboratory results are present, the appropriate radiological imaging must be performed:
  • for AST/ALT ≥2×ULN or ALP ≥2×ULN (not in the bone fraction), an abdominal CT or MRI must be done
  • for ALP≥2×ULN in the bone fraction, a bone scan must be done; a confirmatory x-ray, CT scan or MRI scan or biopsy is required if the results of the bone scan are inconclusive
  • Have a unilateral/bilateral mammogram within 12 months prior to study entry;
  • Have an analysis of both ER and PgR on the primary tumor prior to study entry;
  • Have a cardiac ejection fraction within institutional range of normal as measured by either echocardiogram or multigated acquisition scans;
  • Have an Eastern Cooperative Oncology Group Performance Status of 0 to 1;
  • Women with a history of non-breast malignancies are eligible if they have been disease-free for at least 5 years and are deemed by the investigator to be at low risk for recurrence. Women with the following cancers are eligible if diagnosed and treated within the past 5 years: cervical carcinoma in situ, melanoma in situ, and basal cell or squamous cell carcinoma of the skin;
  • Are able to swallow and retain oral medication;
  • Have a paraffin-embedded tissue block from an archived tumor tissue from the primary tumor or twenty (20) slides of paraffin-embedded tissue available for biomarker analysis;
  • Have adequate organ function defined as: absolute neutrophil count ≥1.5× 10^9/L; hemoglobin ≥9 g/dL; platelets ≥75 × 10^9/L; albumin ≥2.5 g/dL; serum bilirubin ≤1.25 ×ULN; aspartate aminotransferase and alanine aminotransferase ≤3 × ULN and serum creatinine ≤2.0 mg/dL or calculated creatinine clearance ≥40 mL/min
  • Have signed the informed consent form (ICF);
  • Women of child-bearing potential must have a negative serum pregnancy test at screening and agree to complete abstinence from intercourse or consistent and correct use of an acceptable methods of birth control from 2 weeks prior to administration of the first dose of study medication until 28 days after the final dose of study medication:

Who cannot join

  • Have clinical and radiologic evidence of local or regional recurrence of disease or metastatic disease at the time of study entry;
  • Had metachronous invasive breast cancer (breast cancers diagnosed at different times);
  • Have a prior history of other breast cancer malignancies, including DCIS;
  • Are unable to provide archived tumor tissue samples for assay;
  • Had prior therapy with an ErbB1 and/or ErbB2 inhibitor; women who experienced a hypersensitivity or allergic reaction to trastuzumab during the first infusion and were unable to complete this infusion are eligible;
  • Receive concurrent anti-cancer therapy (chemotherapy, immunotherapy, and biologic therapy) while taking study medication;
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  • Have unresolved or unstable, serious toxicity from prior administration of another investigational drug and/or of prior cancer treatment;
  • Have malabsorption syndrome, disease significantly affecting gastrointestinal function, or resection of the stomach or small bowel. Women with ulcerative colitis are also excluded;
  • Have a concurrent disease or condition that would make the woman inappropriate for study participation, or any serious medical disorder that would interfere with the woman's safety;
  • Have an active or uncontrolled infection;
  • Have dementia, altered mental status, or any psychiatric condition that would prohibit the understanding or rendering of informed consent;
  • Have a known history of uncontrolled or symptomatic angina, arrhythmias, or CHF;
  • Are pregnant or breastfeeding;
  • Receive concurrent treatment with an investigational agent; women, who are in follow-up in another clinical trial where the primary endpoint has been met and the interval between assessments is ≥12 months and radiological imaging is not required at these assessments, are eligible;
  • Receive concurrent treatment with a selected list of strong inducers and inhibitors of CYP3A4;
  • Used an investigational drug within 30 days or 5 half-lives, whichever is longer, preceding the first dose of study medication;
  • Have a known immediate or delayed hypersensitivity reaction or idiosyncrasy to drugs chemically related to lapatinib or excipients;

Trial locations and contacts

439 sites in 33 countries.

439 sites in 33 countries

United States103 sites

  • GSK Investigational Site

    Albany, New York, 12206

  • GSK Investigational Site

    Ames, Iowa, 50010

  • GSK Investigational Site

    Anaheim, California, 92801

  • GSK Investigational Site

    Augusta, Georgia, 30901

  • GSK Investigational Site

    Austin, Texas, 78705

  • GSK Investigational Site

    Austin, Texas, 78759

  • GSK Investigational Site

    Bakersfield, California, 93309

  • GSK Investigational Site

    Bedford, Texas, 76022

  • GSK Investigational Site

    Bethesda, Maryland, 20817

  • GSK Investigational Site

    Boca Raton, Florida, 33428

  • GSK Investigational Site

    Boston, Massachusetts, 02114

  • GSK Investigational Site

    Boynton Beach, Florida, 33437

  • GSK Investigational Site

    Charleston, North Carolina, 29406

  • GSK Investigational Site

    Charleston, South Carolina, 29414

  • GSK Investigational Site

    Chattanooga, Tennessee, 37403

  • GSK Investigational Site

    Cherry Hill, New Jersey, 08003

  • GSK Investigational Site

    Chesapeake, Virginia, 23320

  • GSK Investigational Site

    Chicago, Illinois, 60611-2906

  • GSK Investigational Site

    Chicago, Illinois, 60611

  • GSK Investigational Site

    Cleveland, Ohio, 44106

  • GSK Investigational Site

    Cleveland, Ohio, 44195

  • GSK Investigational Site

    Columbia, Missouri, 65201

  • GSK Investigational Site

    Columbus, Ohio, 43215

  • GSK Investigational Site

    Dallas, Texas, 75230

  • GSK Investigational Site

    Dallas, Texas, 75231

  • GSK Investigational Site

    Dallas, Texas, 75246

  • GSK Investigational Site

    Danvers, Massachusetts, 01923

  • GSK Investigational Site

    Denver, Colorado, 80220

  • GSK Investigational Site

    Drexel Hill, Pennsylvania, 19026

  • GSK Investigational Site

    Duluth, Minnesota, 55805

  • GSK Investigational Site

    Duncanville, Texas, 75137

  • GSK Investigational Site

    East Setauket, New York, 11733

  • GSK Investigational Site

    Edina, Minnesota, 55435

  • GSK Investigational Site

    El Paso, Texas, 79902

  • GSK Investigational Site

    Fairfax, Virginia, 22031

  • GSK Investigational Site

    Fairfield, Connecticut, 06824

  • GSK Investigational Site

    Fayetteville, Arkansas, 72703

  • GSK Investigational Site

    Fort Worth, Texas, 76104

  • GSK Investigational Site

    Gainesville, Florida, 32605

  • GSK Investigational Site

    Gastonia, North Carolina, 28054

  • GSK Investigational Site

    Germantown, Tennessee, 38138

  • GSK Investigational Site

    Gilroy, California, 95020

  • GSK Investigational Site

    Greensboro, North Carolina, 27403

  • GSK Investigational Site

    Hickory, North Carolina, 28602

  • GSK Investigational Site

    Hooksett, New Hampshire, 03106

  • GSK Investigational Site

    Houston, Texas, 77024

  • GSK Investigational Site

    Houston, Texas, 77030

  • GSK Investigational Site

    Indianapolis, Indiana, 46219

  • GSK Investigational Site

    Joliet, Illinois, 60435

  • GSK Investigational Site

    Jonesboro, Arkansas, 72401

  • GSK Investigational Site

    Kalamazoo, Michigan, 49048

  • GSK Investigational Site

    Kansas City, Missouri, 64118

  • GSK Investigational Site

    Kirkland, Washington

  • GSK Investigational Site

    La Jolla, California, 92037

  • GSK Investigational Site

    La Verne, California, 91750

  • GSK Investigational Site

    Little Rock, Arkansas, 72205

  • GSK Investigational Site

    Louisville, Kentucky, 40245

  • GSK Investigational Site

    Marietta, Georgia, 30060

  • GSK Investigational Site

    Marrero, Louisiana, 70072

  • GSK Investigational Site

    Memphis, Tennessee, 38120

  • GSK Investigational Site

    Middletown, Ohio, 45042

  • GSK Investigational Site

    Minneapolis, Minnesota, 55404

  • GSK Investigational Site

    Morristown, New Jersey, 07962

  • GSK Investigational Site

    Mount Kisco, New York, 10590

  • GSK Investigational Site

    New Port Richey, Florida, 34655

  • GSK Investigational Site

    New York, New York, 10003

  • GSK Investigational Site

    New York, New York, 10016

  • GSK Investigational Site

    Newton, Massachusetts, 02462

  • GSK Investigational Site

    Norwalk, Connecticut, 06856

  • GSK Investigational Site

    Ocala, Florida, 34474

  • GSK Investigational Site

    Ogden, Utah, 84403

  • GSK Investigational Site

    Orlando, Florida, 32806

  • GSK Investigational Site

    Palm Springs, California, 92262

  • GSK Investigational Site

    Paramus, New Jersey, 07652

  • GSK Investigational Site

    Park Ridge, Illinois, 60068

  • GSK Investigational Site

    Philadelphia, Pennsylvania, 19107

  • GSK Investigational Site

    Phoenix, Arizona, 85012

  • GSK Investigational Site

    Plantation, Florida, 33324

  • GSK Investigational Site

    Port Saint Lucie, Florida, 34952

  • GSK Investigational Site

    Rancho Mirage, California, 92270

  • GSK Investigational Site

    Richlands, Virginia, 24641

  • GSK Investigational Site

    Robbinsdale, Minnesota, 55422

  • GSK Investigational Site

    Rochester, New York, 14623

  • GSK Investigational Site

    Round Rock, Texas, 78681

  • GSK Investigational Site

    Saint Joseph, Missouri, 64507

  • GSK Investigational Site

    San Antonio, Texas, 78229

  • GSK Investigational Site

    Scarborough, Maine, 4074

  • GSK Investigational Site

    Seattle, Washington, 98104

  • GSK Investigational Site

    Sedona, Arizona, 86336

  • GSK Investigational Site

    Sioux City, Iowa, 51101-1733

  • GSK Investigational Site

    Sparta, New Jersey, 07871

  • GSK Investigational Site

    St Louis, Missouri, 63109

  • GSK Investigational Site

    St Louis, Missouri, 63141

  • GSK Investigational Site

    Torrington, Connecticut, 06790

  • GSK Investigational Site

    Tucson, Arizona, 85715

  • GSK Investigational Site

    Tuscaloosa, Alabama, 35406

  • GSK Investigational Site

    Tyler, Texas, 75702

  • GSK Investigational Site

    Vancouver, Washington, 98684

  • GSK Investigational Site

    Waco, Texas, 76712

  • GSK Investigational Site

    Washington D.C., District of Columbia, 20007

  • GSK Investigational Site

    Washington D.C., District of Columbia, 20010

  • GSK Investigational Site

    Wichita, Kansas, 67214

  • GSK Investigational Site

    Yakima, Washington, 98902

Other trials in United States

Germany98 sites

  • GSK Investigational Site

    Amberg, Bavaria, 92224

  • GSK Investigational Site

    Aschaffenburg, Bavaria, 63739

  • GSK Investigational Site

    Bayreuth, Bavaria, 95445

  • GSK Investigational Site

    Berlin, State of Berlin, 10117

  • GSK Investigational Site

    Berlin, State of Berlin, 10367

  • GSK Investigational Site

    Berlin, State of Berlin, 12683

  • GSK Investigational Site

    Berlin, State of Berlin, 13125

  • GSK Investigational Site

    Berlin, State of Berlin, 13156

  • GSK Investigational Site

    Berlin, State of Berlin, 14169

  • GSK Investigational Site

    Berlin, State of Berlin, 14197

  • GSK Investigational Site

    Blankenburg, Saxony-Anhalt, 38889

  • GSK Investigational Site

    Bochum, North Rhine-Westphalia, 44799

  • GSK Investigational Site

    Bonn, North Rhine-Westphalia, 53113

  • GSK Investigational Site

    Bremen, Free Hanseatic City of Bremen, 28177

  • GSK Investigational Site

    Bremen, Free Hanseatic City of Bremen, 28209

  • GSK Investigational Site

    Chemnitz, Saxony, 09116

  • GSK Investigational Site

    Cologne, North Rhine-Westphalia, 50677

  • GSK Investigational Site

    Cologne, North Rhine-Westphalia, 50937

  • GSK Investigational Site

    Cottbus, Brandenburg, 03046

  • GSK Investigational Site

    Deggendorf, Bavaria, 94469

  • GSK Investigational Site

    Dresden, Saxony, 01307

  • GSK Investigational Site

    Duisburg, North Rhine-Westphalia, 47051

  • GSK Investigational Site

    Duisburg, North Rhine-Westphalia, 47166

  • GSK Investigational Site

    Düsseldorf, North Rhine-Westphalia, 40235

  • GSK Investigational Site

    Ebersberg, Bavaria, 85560

  • GSK Investigational Site

    Eggenfelden, Bavaria, 84307

  • GSK Investigational Site

    Eisenach, Thuringia, 99817

  • GSK Investigational Site

    Erlangen, Bavaria, 91054

  • GSK Investigational Site

    Essen, North Rhine-Westphalia, 45130

  • GSK Investigational Site

    Frankfurt am Main, Hesse, 60389

  • GSK Investigational Site

    Frankfurt am Main, Hesse, 60590

  • GSK Investigational Site

    Frankfurt am Main, Hesse, 60596

  • GSK Investigational Site

    Frankfurt am Main, Hesse, 65929

  • GSK Investigational Site

    Freiburg im Breisgau, Baden-Wurttemberg, 79106

  • GSK Investigational Site

    Fürstenwalde, Brandenburg, 15517

  • GSK Investigational Site

    Fürth, Bavaria, 90766

  • GSK Investigational Site

    Goslar, Lower Saxony, 38642

  • GSK Investigational Site

    Güstrow, Mecklenburg-Vorpommern, 18273

  • GSK Investigational Site

    Halle, Saxony-Anhalt, 06120

  • GSK Investigational Site

    Hamburg, Free and Hanseatic City of Hamburg, 20246

  • GSK Investigational Site

    Hamburg, Free and Hanseatic City of Hamburg, 22081

  • GSK Investigational Site

    Hamburg, Free and Hanseatic City of Hamburg, 22457

  • GSK Investigational Site

    Hanover, Lower Saxony, 30625

  • GSK Investigational Site

    Heidelberg, Baden-Wurttemberg, 69115

  • GSK Investigational Site

    Herne, North Rhine-Westphalia, 44623

  • GSK Investigational Site

    Hilden, North Rhine-Westphalia, 40724

  • GSK Investigational Site

    Hildesheim, Lower Saxony, 31134

  • GSK Investigational Site

    Homburg/Saar, Saarland, 66421

  • GSK Investigational Site

    Jena, Thuringia, 07743

  • GSK Investigational Site

    Kassel, Hesse, 34117

  • GSK Investigational Site

    Kassel, Hesse, 34131

  • GSK Investigational Site

    Kauschwitz, Saxony, 08525

  • GSK Investigational Site

    Kempten (Allgäu), Bavaria, 87439

  • GSK Investigational Site

    Kiel, Schleswig-Holstein, 24103

  • GSK Investigational Site

    Koblenz, Rhineland-Palatinate, 56068

  • GSK Investigational Site

    Konstanz, Baden-Wurttemberg, 78464

  • GSK Investigational Site

    Krumbach, Bavaria, 86381

  • GSK Investigational Site

    Lübeck, Schleswig-Holstein, 23538

  • GSK Investigational Site

    Magdeburg, Saxony-Anhalt, 39104

  • GSK Investigational Site

    Magdeburg, Saxony-Anhalt, 39108

  • GSK Investigational Site

    Mainz, Rhineland-Palatinate, 55131

  • GSK Investigational Site

    Mannheim, Baden-Wurttemberg, 68161

  • GSK Investigational Site

    Marktredwitz, Bavaria, 95615

  • GSK Investigational Site

    Mayen, Baden-Wurttemberg, 56727

  • GSK Investigational Site

    Memmingen, Bavaria, 87700

  • GSK Investigational Site

    Mülheim, North Rhine-Westphalia, 45473

  • GSK Investigational Site

    Munich, Bavaria, 80331

  • GSK Investigational Site

    Munich, Bavaria, 80335

  • GSK Investigational Site

    Munich, Bavaria, 80337

  • GSK Investigational Site

    Munich, Bavaria, 80637

  • GSK Investigational Site

    Munich, Bavaria, 81377

  • GSK Investigational Site

    Mutlangen, Baden-Wurttemberg, 73557

  • GSK Investigational Site

    Neunkirchen, Saarland, 66538

  • GSK Investigational Site

    Neustadt, Saxony, 01844

  • GSK Investigational Site

    Porta Westfalica, North Rhine-Westphalia, 32457

  • GSK Investigational Site

    Recklinghausen, North Rhine-Westphalia, 45657

  • GSK Investigational Site

    Rehling, Bavaria, 86508

  • GSK Investigational Site

    Rheinfelden, Baden-Wurttemberg, 79618

  • GSK Investigational Site

    Rosenheim, Bavaria, 83022

  • GSK Investigational Site

    Roth, Bavaria, 91154

  • GSK Investigational Site

    Saarbrücken, Saarland, 66113

  • GSK Investigational Site

    Salzgitter, Lower Saxony, 38226

  • GSK Investigational Site

    Schwandorf in Bayern, Bavaria, 92421

  • GSK Investigational Site

    Schwetzingen, Baden-Wurttemberg, 68723

  • GSK Investigational Site

    Singen, Baden-Wurttemberg, 78224

  • GSK Investigational Site

    Spremberg, Saxony, 03130

  • GSK Investigational Site

    Stendal, Saxony-Anhalt, 39576

  • GSK Investigational Site

    Stuttgart, Baden-Wurttemberg, 70190

  • GSK Investigational Site

    Stuttgart, Baden-Wurttemberg, 70376

  • GSK Investigational Site

    Troisdorf, North Rhine-Westphalia, 53840

  • GSK Investigational Site

    Tübingen, Baden-Wurttemberg, 72076

  • GSK Investigational Site

    Ulm, Baden-Wurttemberg, 89075

  • GSK Investigational Site

    Velbert, North Rhine-Westphalia, 42551

  • GSK Investigational Site

    Weiden, Bavaria, 92637

  • GSK Investigational Site

    Wiesbaden, Hesse, 65191

  • GSK Investigational Site

    Witten, North Rhine-Westphalia, 58452

  • GSK Investigational Site

    Zittau, Saxony, 02763

  • GSK Investigational Site

    Zwickau, Saxony, 08060

Other trials in Germany

France29 sites

  • GSK Investigational Site

    Angers, 49933

  • GSK Investigational Site

    Besançon, 25030

  • GSK Investigational Site

    Bordeaux, 33000

  • GSK Investigational Site

    Caen, 14076

  • GSK Investigational Site

    Clermont-Ferrand, 63000

  • GSK Investigational Site

    Colmar, 68024

  • GSK Investigational Site

    Dijon, 21079

  • GSK Investigational Site

    Lille, 59000

  • GSK Investigational Site

    Lille, 59020

  • GSK Investigational Site

    Lyon, 69008

  • GSK Investigational Site

    Lyon, 69373

  • GSK Investigational Site

    Marseille, 13273

  • GSK Investigational Site

    Montbéliard, 25200

  • GSK Investigational Site

    Montpellier, 34298

  • GSK Investigational Site

    Nantes, 44202

  • GSK Investigational Site

    Nice, 06189

  • GSK Investigational Site

    Paris, 75908

  • GSK Investigational Site

    Reims, 51100

  • GSK Investigational Site

    Rennes, 35042

  • GSK Investigational Site

    Saint-Cloud, 92210

  • GSK Investigational Site

    Saint-Grégoire, 35760

  • GSK Investigational Site

    Saint-Herblain, 44805

  • GSK Investigational Site

    Strasbourg, 67000

  • GSK Investigational Site

    Toulouse, 31059

  • GSK Investigational Site

    Toulouse, 31076

  • GSK Investigational Site

    Tourcoing, 59200

  • GSK Investigational Site

    Vandœuvre-lès-Nancy, 54511

  • GSK Investigational Site

    Villejuif, 94804

  • GSK Investigational Site

    Villejuif, 94805

Other trials in France

Australia22 sites

  • GSK Investigational Site

    Bedford Park, South Australia, 5042

  • GSK Investigational Site

    Box Hill, Victoria, 3128

  • GSK Investigational Site

    Campbelltown, New South Wales, 2560

  • GSK Investigational Site

    Darlinghurst, New South Wales, 2010

  • GSK Investigational Site

    Douglas, Queensland, 4814

  • GSK Investigational Site

    East Melbourne, Victoria, 3002

  • GSK Investigational Site

    Elizabeth Vale, South Australia, 5112

  • GSK Investigational Site

    Fitzroy, Victoria, 3065

  • GSK Investigational Site

    Footscray, Victoria, 3011

  • GSK Investigational Site

    Heidelberg, Victoria, 3084

  • GSK Investigational Site

    Herston, Queensland, 4029

  • GSK Investigational Site

    Kogarah, New South Wales, 2217

  • GSK Investigational Site

    Liverpool, New South Wales, 2170

  • GSK Investigational Site

    Nedlands, Western Australia, 6009

  • GSK Investigational Site

    North Sydney, New South Wales, 2060

  • GSK Investigational Site

    Parkville, Victoria, 3050

  • GSK Investigational Site

    Perth, Western Australia, 6000

  • GSK Investigational Site

    Redcliffe, Queensland, 4020

  • GSK Investigational Site

    Ringwood East, Victoria, 3135

  • GSK Investigational Site

    South Brisbane, Queensland, 4101

  • GSK Investigational Site

    Wodonga, Victoria, 3690

  • GSK Investigational Site

    Woodville, South Australia, 5011

Other trials in Australia

Spain19 sites

  • GSK Investigational Site

    Alcorcón, 28922

  • GSK Investigational Site

    Barcelona, 08003

  • GSK Investigational Site

    Barcelona, 08035

  • GSK Investigational Site

    Cáceres, 10003

  • GSK Investigational Site

    Girona, 17007

  • GSK Investigational Site

    Jaén, 23007

  • GSK Investigational Site

    Lleida, 25198

  • GSK Investigational Site

    Llobregat, 08907

  • GSK Investigational Site

    Madrid, 28034

  • GSK Investigational Site

    Madrid, 28040

  • GSK Investigational Site

    Mataró, 08304

  • GSK Investigational Site

    Ourense, 32005

  • GSK Investigational Site

    Palma de Mallorca, 07010

  • GSK Investigational Site

    Palma de Mallorca, 07198

  • GSK Investigational Site

    Santa Cruz de Tenerife, 38320

  • GSK Investigational Site

    Santander, 39008

  • GSK Investigational Site

    Santiago de Compostela, 15706

  • GSK Investigational Site

    Valencia, 46010

  • GSK Investigational Site

    Zaragoza, 50009

Other trials in Spain

Canada17 sites

  • GSK Investigational Site

    Barrie, Ontario, L4M 6M2

  • GSK Investigational Site

    Brampton, Ontario, L6W 2Z8

  • GSK Investigational Site

    Greenfield Park, Quebec, J4V 2H1

  • GSK Investigational Site

    Halifax, Nova Scotia, B3H 1V7

  • GSK Investigational Site

    Kingston, Ontario, K7L 5P9

  • GSK Investigational Site

    London, Ontario, N6A 4L6

  • GSK Investigational Site

    Mississauga, Ontario, L5M 2N1

  • GSK Investigational Site

    Montreal, Quebec, H3T 1E2

  • GSK Investigational Site

    Oshawa, Ontario, L1G 2B9

  • GSK Investigational Site

    Ottawa, Ontario, K1H 8L6

  • GSK Investigational Site

    Québec, Quebec, G1S 4L8

  • GSK Investigational Site

    Saskatoon, Saskatchewan, S7N 4H4

  • GSK Investigational Site

    St. John's, Newfoundland and Labrador, A1B 3V6

  • GSK Investigational Site

    Toronto, Ontario, M4C 3E7

  • GSK Investigational Site

    Toronto, Ontario, M4N 3M5

  • GSK Investigational Site

    Toronto, Ontario, M5B 1W8

  • GSK Investigational Site

    Toronto, Ontario, M6R 1B5

Other trials in Canada

United Kingdom17 sites

  • GSK Investigational Site

    Bournemouth, BH7 7DW

  • GSK Investigational Site

    Chelmsford, Essex, CM1 7ET

  • GSK Investigational Site

    Edgbaston, Birmingham, B15 2TH

  • GSK Investigational Site

    Glasgow, G12 OYN

  • GSK Investigational Site

    Lindley, HD3 3EA

  • GSK Investigational Site

    London, NW1 2PG

  • GSK Investigational Site

    London, NW3 2QG

  • GSK Investigational Site

    London, SE1 9RT

  • GSK Investigational Site

    London, SW3 6JJ

  • GSK Investigational Site

    Maidstone, ME16 9QQ

  • GSK Investigational Site

    Manchester, Lancashire, M20 4BX

  • GSK Investigational Site

    Manchester, M23 9LT

  • GSK Investigational Site

    Newcastle upon Tyne, NE7 7DN

  • GSK Investigational Site

    Nottingham, NG5 1PB

  • GSK Investigational Site

    Sheffield, S10 2SJ

  • GSK Investigational Site

    Shrewsbury, SY3 8XQ

  • GSK Investigational Site

    Sutton, Surrey, SM2 5PT

Other trials in United Kingdom

Argentina10 sites

  • GSK Investigational Site

    Buenos Aires, C1417DTN

  • GSK Investigational Site

    Capital Federal, Buenos Aires, C1405CUB

  • GSK Investigational Site

    Ciudad Autonoma de Buenos Aires, Buenos Aires, C1185AAT

  • GSK Investigational Site

    Ciudad Autonoma de Buenos Aires, Buenos Aires, C1405BCH

  • GSK Investigational Site

    Córdoba, Córdoba Province, X5006HBF

  • GSK Investigational Site

    Neuquén, Neuquén Province, Q8300HDH

  • GSK Investigational Site

    Quilmes, 1878

  • GSK Investigational Site

    Rosario, Santa Fe Province, S2000KZE

  • GSK Investigational Site

    San Miguel de Tucumán, T4000IAK

  • GSK Investigational Site

    Santa Fe, Santa Fe Province, 3000

Other trials in Argentina

South Africa9 sites

  • GSK Investigational Site

    Athlone Park, Amanzimtoti, 4126

  • GSK Investigational Site

    Groenkloof, 0181

  • GSK Investigational Site

    Kraaifontein, 7570

  • GSK Investigational Site

    Overport, 4091

  • GSK Investigational Site

    Parktown, 2193

  • GSK Investigational Site

    Port Elizabeth, 6045

  • GSK Investigational Site

    Sandton, 2199

  • GSK Investigational Site

    Saxonwold, Johannesburg, 2196

  • GSK Investigational Site

    Tygerberg, Western Province, 7505

Other trials in South Africa

China8 sites

  • GSK Investigational Site

    Beijing, 100021

  • GSK Investigational Site

    Beijing, 100036

  • GSK Investigational Site

    Beijing, 100071

  • GSK Investigational Site

    Guangzhou, Guangdong, 510060

  • GSK Investigational Site

    Jinan, Shandong, 250117

  • GSK Investigational Site

    Shanghai, 200032

  • GSK Investigational Site

    Tianjin, 300060

  • GSK Investigational Site

    Wuhan, Hubei, 430030

Other trials in China

Denmark8 sites

  • GSK Investigational Site

    Aalborg, 9100

  • GSK Investigational Site

    Copenhagen, DK-2100

  • GSK Investigational Site

    Esbjerg, 6700

  • GSK Investigational Site

    Herlev, DK-2730

  • GSK Investigational Site

    Næstved, 4700

  • GSK Investigational Site

    Odense, 5000

  • GSK Investigational Site

    Roskilde, 4000

  • GSK Investigational Site

    Vejle, 7100

Other trials in Denmark

Hungary7 sites

  • GSK Investigational Site

    Budapest, 1076

  • GSK Investigational Site

    Budapest

  • GSK Investigational Site

    Győr, 9023

  • GSK Investigational Site

    Kaposvár, 7400

  • GSK Investigational Site

    Kistarcsa, 2143

  • GSK Investigational Site

    Pécs, 7624

  • GSK Investigational Site

    Szeged, 6720

Other trials in Hungary

Israel7 sites

  • GSK Investigational Site

    Ashkelon, 78278

  • GSK Investigational Site

    Haifa, 34362

  • GSK Investigational Site

    Jerusalem, 91120

  • GSK Investigational Site

    Kfar Saba, 44281

  • GSK Investigational Site

    Ramat Gan, 52621

  • GSK Investigational Site

    Rehovot, 76100

  • GSK Investigational Site

    Tel Aviv, 64239

Other trials in Israel

Russia7 sites

  • GSK Investigational Site

    Moscow, 115 478

  • GSK Investigational Site

    Moscow, 117997

  • GSK Investigational Site

    Moscow, 129301

  • GSK Investigational Site

    Ryazan, 390011

  • GSK Investigational Site

    Saint Petersburg, 197022

  • GSK Investigational Site

    Saint Petersburg, 197758

  • GSK Investigational Site

    Yaroslavl, 150054

Other trials in Russia

Brazil6 sites

  • GSK Investigational Site

    Belo Horizonte, Minas Gerais, 30.140-001

  • GSK Investigational Site

    Porto Alegre, Rio Grande do Sul, 90020-090

  • GSK Investigational Site

    Porto Alegre, Rio Grande do Sul, 90610 000

  • GSK Investigational Site

    Rio de Janeiro, Rio de Janeiro, 21941-913

  • GSK Investigational Site

    Santo André, São Paulo, 09060-670

  • GSK Investigational Site

    São Paulo, São Paulo, 03102-002

Other trials in Brazil

India6 sites

  • GSK Investigational Site

    Chennai, 600035

  • GSK Investigational Site

    Hyderabad, 500082

  • GSK Investigational Site

    Jaipur, 302013

  • GSK Investigational Site

    Mumbai, 400012

  • GSK Investigational Site

    New Delhi

  • GSK Investigational Site

    Pune, 411001

Other trials in India

Italy6 sites

  • GSK Investigational Site

    Avellino, Campania, 83100

  • GSK Investigational Site

    Genoa, Liguria, 16132

  • GSK Investigational Site

    Negrar (Verona), Veneto, 37024

  • GSK Investigational Site

    Perugia, Umbria, 06132

  • GSK Investigational Site

    Piacenza, Emilia-Romagna, 29100

  • GSK Investigational Site

    Sassari, Sardinia, 07100

Other trials in Italy

Poland6 sites

  • GSK Investigational Site

    Bydgoszcz, 85-792

  • GSK Investigational Site

    Krakow, 31-115

  • GSK Investigational Site

    Olsztyn, 10-226

  • GSK Investigational Site

    Olsztyn, 10-228

  • GSK Investigational Site

    Torun, 87-100

  • GSK Investigational Site

    Warsaw, 00-909

Other trials in Poland

Croatia5 sites

  • GSK Investigational Site

    Osijek, 31000

  • GSK Investigational Site

    Pula, 52 100

  • GSK Investigational Site

    Rijeka, 51000

  • GSK Investigational Site

    Split, 21000

  • GSK Investigational Site

    Zagreb, 10 000

Other trials in Croatia

Greece5 sites

  • GSK Investigational Site

    Athens, 115 27

  • GSK Investigational Site

    Athens, 11527

  • GSK Investigational Site

    Athens, 185 37

  • GSK Investigational Site

    Chania, 73100

  • GSK Investigational Site

    Heraklion, Crete, 71110

Other trials in Greece

Mexico5 sites

  • GSK Investigational Site

    Chihuahua City, Chihuahua, 31000

  • GSK Investigational Site

    DF., 01120

  • GSK Investigational Site

    Mérida, Yucatán, 97500

  • GSK Investigational Site

    Mexico City, CP 14080

  • GSK Investigational Site

    México D.F., 11000

Other trials in Mexico

Chile4 sites

  • GSK Investigational Site

    Santiago, Región Metro de Santiago, 750 1088

  • GSK Investigational Site

    Santiago, Región Metro de Santiago, 7500921

  • GSK Investigational Site

    Santiago, Región Metro de Santiago, 7591046

  • GSK Investigational Site

    Viña del Mar, Valparaiso, 254-0364

Other trials in Chile

Philippines4 sites

  • GSK Investigational Site

    Baguio City, Benguet, 2600

  • GSK Investigational Site

    Cebu, 6000

  • GSK Investigational Site

    Pasig, 1600

  • GSK Investigational Site

    Quezon City, 1101

Other trials in Philippines

Slovakia4 sites

  • GSK Investigational Site

    Banská Bystrica, 975 17

  • GSK Investigational Site

    Bardejov, 085 01

  • GSK Investigational Site

    Bratislava, 833 10

  • GSK Investigational Site

    Nitra, 950 01

Other trials in Slovakia

South Korea4 sites

  • GSK Investigational Site

    Goyang-si, Gyeonggi-do, 410-769

  • GSK Investigational Site

    Seoul, 110-744

  • GSK Investigational Site

    Seoul, 135-710

  • GSK Investigational Site

    Songpa-gu, Seoul, 138-736

Other trials in South Korea

Ukraine4 sites

  • GSK Investigational Site

    Dnipro, 49102

  • GSK Investigational Site

    Kyiv, 03115

  • GSK Investigational Site

    Lviv, 79031

  • GSK Investigational Site

    Uzhhorod, 88017

Other trials in Ukraine

Czechia3 sites

  • GSK Investigational Site

    Brno, 656 53

  • GSK Investigational Site

    Prague, 121 00

  • GSK Investigational Site

    Prague, 180 00

Other trials in Czechia

Hong Kong3 sites

  • GSK Investigational Site

    Hong Kong

  • GSK Investigational Site

    Shatin

  • GSK Investigational Site

    Wan Chai

Other trials in Hong Kong

Latvia3 sites

  • GSK Investigational Site

    Liepāja, LV3401

  • GSK Investigational Site

    Riga, LV 1002

  • GSK Investigational Site

    Riga, LV 1079

Other trials in Latvia

Lithuania3 sites

  • GSK Investigational Site

    Kaunas, LT-50009

  • GSK Investigational Site

    Klaipėda, LT-92228

  • GSK Investigational Site

    Vilnius, LT-08660

Other trials in Lithuania

New Zealand3 sites

  • GSK Investigational Site

    Auckland, 1023

  • GSK Investigational Site

    Christchurch, 8001

  • GSK Investigational Site

    Hamilton, 2001

Other trials in New Zealand

Peru3 sites

  • GSK Investigational Site

    Lima, Lima Province, Lima 11

  • GSK Investigational Site

    Lima, Lima Province, Lima 13

  • GSK Investigational Site

    Lima, Lima Province, Lima 34

Other trials in Peru

Belgium1 site

  • GSK Investigational Site

    Brussels, 1000

Other trials in Belgium

About this study

Official title: A Randomized, Double-blind, Multicenter, Placebo-controlled Study of Adjuvant Lapatinib (GW572016) in Women With Early-Stage ErbB2 Overexpressing Breast Cancer

This study was designed to evaluate and compare the safety and efficacy of an oral dual tyrosine kinase inhibitor, lapatinib, versus placebo in women with early-stage ErbB2-overexpressing breast cancer who have completed their primary neoadjuvant or adjuvant chemotherapy and have no clinical or radiographic evidence of disease.

Being tested
lapatinib, placebo
Keywords
Breast Cancer, ErbB2-overexpressing, early-stage breast cancer, adjuvant
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

    Lapatinib 1500 mg (6 tablets) daily for 12 months

  • placeboOther

    6 tablets daily for 12 months

Study groups in NCT00374322
Study groupRoleWhat they receive
PlaceboPlacebo comparator6 tablets daily for 12 months
Receives: Other: placebo
LapatinibExperimentalLapatinib 1500 mg (6 tablets) daily for 12 months
Receives: Drug: lapatinib

What is being measured

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

  1. Number of Participants (Par.) With Any Recurrence of the Initial Disease, Second Primary Cancer, Contralateral Breast Cancer, or Death (Disease-free Survival [DFS])

    DFS=interval between the date of randomization and the date of the first occurrence of an objective disease recurrence, a second primary cancer, or death from any cause. The date of the event is the earliest date of the occurrence of any of the following: local recurrence (LR) following mastectomy; LR in ipsilateral breast following lumpectomy; regional recurrence; distant recurrence; contralateral breast cancer, including ductal carcinoma in situ; other second primary cancer (excluding squamous or basal cell carcinoma of the skin, melanoma in situ, carcinoma in situ of the cervix, or lobular carcinoma in situ of the breast); death from any cause without a prior event. Par. who started additional anti-cancer adjuvant therapy prior to the recurrence of their disease were to be censored. Par. who did not withdraw from the study and did not experience a specified event or death were to be censored (follow-up ongoing) at the last visit date available at which progression was assessed.

    Measured: From randomization until date of the first occurrence of an objective disease recurrence, a second primary cancer, or death from any cause (assessed up to 6 years; 1 year of treatment, 5 years of follow-up [median of 5.3 years for final analysis])

Secondary outcomes (15)

  1. Number of Participants Who Died (Overall Survival)

    Overall Survival (OS) is defined as the time from randomization until death from any cause. Data are presented as the number of participants who died. For participants who did not die, time to death was censored at the last date the participant was known to be alive.

    Measured: From the date of randomization until death from any cause (assessed up to 6 years; 1 year of treatment and 5 years of follow-up [median of 5.3 years for final analysis])

  2. Percentage of Participants With the Indicated Period of Recurrence-free Survival (Time to First Recurrence)

    Recurrence is defined as experiencing a recurrence of initial disease or contralateral breast cancer after randomization. Time to first recurrence is defined as the interval between the date of randomization and the date of the first occurrence of an objective disease recurrence or contralateral breast cancer. Time to first recurrence included the first occurrence at one of the following sites as an event: local recurrence following mastectomy; local recurrence in ipsilateral breast following lumpectomy; regional recurrence; distant recurrence; contralateral breast cancer, including ductal carcinoma in situ (DCIS).

    Measured: From the date of randomization until the date of the first occurrence of an objective disease recurrence or contralateral breast cancer (assessed up to 6 years; 1 year of treatment and 5.3 years of follow-up [median of 5 years for final analysis])

  3. Percentage of Participants With the Indicated Period of Distant Recurrence-free Survival (Time to Distant Recurrence)

    Distant recurrence (metastatic disease) is defined as a tumor in any area of the body not including those defined as local or regional recurrence. Sites of distant recurrence include: skin, subcutaneous tissue, and lymph nodes (excluding those described for local and regional recurrence); bone marrow; skeletal; lungs and pleural; ascites and pleural effusions; liver and other viscera; and central nervous system (CNS). Time to distant recurrence is defined as the interval between the date of randomization and the date of the first occurrence of a distant recurrence.

    Measured: From the date of randomization until the date of the first occurrence of a distant recurrence (assessed up to 6 years; 1 year of treatment and 5 years of follow-up [median of 5.3 years for final analysis])

  4. Time to Central Nervous System (CNS) Recurrence

    Time to CNS recurrence is defined as the interval between the date of randomization and the date of the occurrence of a CNS recurrence if noted as part of the participant's first recurrence. Time to CNS recurrence was not calculated; data are presented as the number of participants with CNS recurrence in the subsequent outcome measure table.

    Measured: From the date of randomization until the date of the first occurrence of a CNS recurrence (assessed up to 6 years [1 year of treatment and 5 years of follow-up; median of 5.3 years for final analysis])

  5. Number of Participants With CNS Recurrence

    The number of participants experiencing a CNS recurrence was summarized.

    Measured: From the date of randomization until the date of the first occurrence of a CNS recurrence (assessed up to 6 years [1 year of treatment and 5 years of follow-up; median of 5.3 years for final analysis])

  6. Modified Disease-free Survival (MDFS)

    Modified disease recurrence=interval between the date of randomization and the date of the first occurrence of an objective disease recurrence, contralateral breast cancer, or death from any cause. The date of the event=the earliest date of the occurrence of any of the following events: local recurrence following mastectomy; local recurrence in ipsilateral breast following lumpectomy; regional recurrence; distant recurrence; contralateral breast cancer, including DCIS; death from any cause without a prior event. MDFS was not calculated; data are presented as the number of participants with any recurrence of the initial disease, contralateral breast cancer, or death (disease-free survival) in the subsequent outcome measure table.

    Measured: From the date of randomization until the date of the first occurrence of an objective disease recurrence, contralateral breast cancer, or death from any cause (assessed up to 6 years)

  7. Number of Participants With Any Recurrence of the Initial Disease, Contralateral Breast Cancer, or Death (Disease-free Survival [DFS])

    DFS=interval between the date of randomization and the date of the first occurrence of an objective disease recurrence, a second primary cancer, or death from any cause. The date of the event is the earliest date of the occurrence of any of the following: local recurrence (LR) following mastectomy; LR in ipsilateral breast following lumpectomy; regional recurrence; distant recurrence and contralateral breast cancer, including ductal carcinoma in situ; or death from any cause without a prior event. Participants who started additional anti-cancer adjuvant therapy prior to the recurrence of their disease were to be censored. Participants who did not withdraw from the study and did not experience a specified event or death were to be censored (follow-up ongoing) at the last visit date available at which progression was assessed.

    Measured: From the date of randomization until the date of the first occurrence of an objective disease recurrence, contralateral breast cancer, or death from any cause (assessed up to 6 years)

  8. Change From Baseline in Short Form-36 Version 2 (SF-36 v2) Scores for the Physical Component Summary (PCS)

    The SF-36 v2 is a self-administered, health-related quality of life (QoL) metric. It is a 36-item questionnaire designed to measure 8 domains of functional health status and well-being: physical functioning, role-physical, bodily pain, general health perceptions, vitality, social functioning, role-emotional, and mental health. Each domain is scored from 0 (poorer health) to 100 (better health).The PCS score is a summary score representing overall physical health, which is derived from the 8 domain scores. As with each domain score, the PCS score ranges from 0 to 100; higher scores represent better health. Change from Baseline was calculated as the post-Baseline score minus the Baseline score. Missing post-Baseline data were imputed using the last observation carried forward (LOCF) method. The scores were analyzed using an analysis of covariance (ANCOVA) model, adjusting for Baseline sub-scale score, treatment, and country. Positive changes from Baseline indicate improvement.

    Measured: Baseline, Month 6, Month 12, and every 6 months after discontinuation of study treatment for 24 months (up to a maximum of 3 study years)

  9. Change From Baseline in SF-36 v2 Scores for the Mental Component Summary (MCS)

    The SF-36 v2 is a self-administered, health-related quality of life (QoL) metric. It is a 36-item questionnaire designed to measure 8 domains of functional health status and well-being: physical functioning, role-physical, bodily pain, general health perceptions, vitality, social functioning, role-emotional, and mental health. Each domain is scored from 0 (poorer health) to 100 (better health).The MCS score is a summary score representing overall mental health, which is derived from the 8 domain scores. As with each domain score, the MCS score ranges from 0 to 100; higher scores represent better health. Change from Baseline was calculated as the post-Baseline score minus the Baseline score. Missing post-Baseline data were imputed using the LOCF method. The scores were analyzed using an ANCOVA model adjusting for Baseline sub-scale score, treatment, and country. Positive changes from Baseline indicate improvement.

    Measured: Baseline, Month 6, Month 12, and every 6 months after discontinuation of study treatment for 24 months (up to a maximum of 3 study years)

  10. Change From Baseline in the SF-36 v2 Domain Scores for Physical Functioning (PF), Role-Physical (RP), Bodily Pain (BP), General Health (GH), Vitality (VT), Social Functioning (SF), Role-Emotional (RE), and Mental Health (MH)

    The SF-36 v2 is a self-administered, health-related quality of life (QoL) metric. It is a 36-item questionnaire designed to measure 8 domains of functional health status and well-being: physical functioning (PF), role-physical (RP), bodily pain (BP), general health (GH) perceptions, vitality (VT), social functioning (SF), role-emotional (RE), and mental health (MH). Each domain is scored from 0 (poorer health) to 100 (better health); higher scores represent better health. Change from Baseline was calculated as the post-Baseline score minus the Baseline score. Missing post-Baseline data were imputed using the LOCF method. The scores were analyzed using an ANCOVA model, adjusting for Baseline sub-scale score, treatment, and country. Positive changes from Baseline indicate improvement.

    Measured: Baseline, Month 6, Month 12, and every 6 months after discontinuation of study treatment for 24 months (up to a maximum of 3 study years)

  11. Number of Participants With Hematology Values Outside the Reference Range for the Indicated Parameters

    The hematology parameters assessed were: basophils (Bs) in giga (10^9) per liter (GI/L) and in percentage (%), eosinophils (Eo) in GI/L and %, hematocrit, hemoglobin, lymphocytes (Lmph) in GI/L and %, monocytes (Mono) in GI/L and %, platelet count, Red Blood Cell (RBC) count, total neutrophil count (TNC) in GI/L and %, and White Blood Cell (WBC) count. The Baseline (BL) value is the last available pre-treatment result recorded. "Any post-Baseline value" was based on results recorded at any scheduled or unscheduled post-Baseline visits. The prevalence of values lying outside the reference (ref.) range (high or low) is presented for BL and "any post-Baseline" (APBL) visit. Two participants were randomized to placebo but received lapatinib; therefore, they are included in the lapatinib treatment arm. Data for the primary analysis (conducted in 2011) are reported.

    Measured: At Baseline and every 3 months thereafter up to Month 12/Early Withdrawal Visit

  12. Number of Participants With Clinical Chemistry Values Outside the Reference Range for the Indicated Parameters

    The clinical chemistry parameters assessed were: alanine amino transferase (ALT), albumin, alkaline phosphatase (ALP), aspartate amino transferase (AST), bicarbonate, blood urea nitrogen (BUN), bone alkaline phosphatase (Bone ALP), calcium, chloride, creatinine, creatinine clearance (Cr. Clearance), creatinine clearance estimated (Cr. Clrnc. est.), glucose, potassium, sodium, total bilirubin (Total Bln), total protein, urea, and uric acid. The Baseline (BL) value is the last available pre-treatment result recorded. "Any post-Baseline" value was based on results recorded at scheduled or unscheduled post-Baseline visits. The prevalence of values lying outside the reference (ref.) range (high or low) was presented for BL and "any post-Baseline" (APBL) visit. Two participants were randomized to placebo but received lapatinib; therefore, they are included in the lapatinib treatment arm.

    Measured: At Baseline and every 6 weeks thereafter up to Month 12/Early Withdrawal Visit

  13. Number of Participants With Non-laboratory Toxicities of the Indicated Toxicity Grades

    Non-laboratory toxicities are defined as adverse events (AEs). The number of partcipants with any treatment-emergent AE of the indicated toxicity grade are summarized. Toxicity grading was according to the National Cancer Institute Common Terminology Criteria for Adverse Events Version 3.0 as follows: Grade 1=mild; Grade 2=moderate; Grade 3=severe; Grade 4=life threatening; Grade 5=death. The events that were not given a toxicity grade are categorized as "Not Applicable."

    Measured: From the first dose of study treatment up to 12 months

  14. Number of Participants Experiencing Primary or Secondary Cardiac Events

    A cardiac event is classified as a primary cardiac endpoint (PCE) or a secondary cardiac endpoint (SCE). PCE is defined as: cardiac death (cardiac death due to heart failure, myocardial infarction, or arrhythmia;or probable cardiac death defined as sudden, unexpected death within 24 hours of a definite or probable cardiac event); severe symptomatic congestive heart failure (CHF) (as per New York Heart Association [NYHA] Class III or IV and an absolute decrease in left ventricular ejection fraction [LVEF] of more than 10 percentage points from Baseline and to a left ventricular ejection fraction [LVEF] value below 50%). SCE is defined as asymptomatic or mildly symptomatic cardiac events (NYHA Class I or II) and a significant decrease in LVEF, defined as an absolute decrease in LVEF of more than 10 percentage points from Baseline and to an LVEF value below 50%.

    Measured: From the date of randomization up to 12 months

  15. Number of Participants With the Indicated Electrocardiogram (ECG) Findings

    12-lead ECG measurements were taken at Screening and at study conclusion/withdrawal. The number of participants with normal, abnormal clinically significant (CS), and abnormal not clinically significant (NCS) ECG findings, as classified by the investigator, were summarized. Participants with missing values were categorized as missing. Data for the primary analysis (conducted in 2011) are reported.

    Measured: Screening and Month 12/Early Withdrawal Visit

Timeline

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

  1. First posted11 Sep 2006 (estimated)
  2. Study startAug 2006
  3. Primary completionSep 2011
  4. Study completionJul 2013

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
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
3,166 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00374322
Sponsor's protocol ID
EGF105485
Status last verified
Jul 2014
First submitted
7 Sep 2006
Last updated
18 Aug 2014
Data monitoring committee
Yes

Publications

  • P Goss, I Smith, J O'Shaughnessy, B Ejlertsen, M Kaufmann, F Boyle, A Buzdar, P Fumoleau, W Gradishar, M Martin, B Moy, M Piccart-Gebhart, K I Pritchard, D Lindquist, Y Chavarri-Guerra, G Aktan, E Rappold, L S Williams, D M Finkelstein. Resubmission: A Randomized Trial of Adjuvant Lapatinib in Women with Early Stage HER2 Overexpressing Breast Cancer. Lancet Oncol. 2012;S 1470-2045(12):70508-9.

  • Boyle FM, Smith IE, O'Shaughnessy J, Ejlertsen B, Buzdar AU, Fumoleau P, Gradishar W, Martin M, Moy B, Piccart-Gebhart M, Pritchard KI, Lindquist D, Amonkar M, Huang Y, Rappold E, Williams LS, Wang-Silvanto J, Kaneko T, Finkelstein DM, Goss PE; TEACH Investigators. Health related quality of life of women in TEACH, a randomised placebo controlled adjuvant trial of lapatinib in early stage Human Epidermal Growth Factor Receptor (HER2) overexpressing breast cancer. Eur J Cancer. 2015 Apr;51(6):685-96. doi: 10.1016/j.ejca.2015.02.005. Epub 2015 Mar 6.

    PubMed 25752740

  • Schaid DJ, Spraggs CF, McDonnell SK, Parham LR, Cox CJ, Ejlertsen B, Finkelstein DM, Rappold E, Curran J, Cardon LR, Goss PE. Prospective validation of HLA-DRB1*07:01 allele carriage as a predictive risk factor for lapatinib-induced liver injury. J Clin Oncol. 2014 Aug 1;32(22):2296-303. doi: 10.1200/JCO.2013.52.9867. Epub 2014 Mar 31.

    PubMed 24687830

  • Goss PE, Smith IE, O'Shaughnessy J, Ejlertsen B, Kaufmann M, Boyle F, Buzdar AU, Fumoleau P, Gradishar W, Martin M, Moy B, Piccart-Gebhart M, Pritchard KI, Lindquist D, Chavarri-Guerra Y, Aktan G, Rappold E, Williams LS, Finkelstein DM; TEACH investigators. Adjuvant lapatinib for women with early-stage HER2-positive breast cancer: a randomised, controlled, phase 3 trial. Lancet Oncol. 2013 Jan;14(1):88-96. doi: 10.1016/S1470-2045(12)70508-9. Epub 2012 Dec 10.

    PubMed 23234763

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing lapatinib in people with Neoplasms, Breast, run by GlaxoSmithKline at 439 sites in 33 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 30 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 18 Aug 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 439 sites in United States, Germany, France, Australia, Spain and 28 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. Some participants in this study may receive a placebo. 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?

Number of Participants (Par.) With Any Recurrence of the Initial Disease, Second Primary Cancer, Contralateral Breast Cancer, or Death (Disease-free Survival [DFS]) (time frame: From randomization until date of the first occurrence of an objective disease recurrence, a second primary cancer, or death from any cause (assessed up to 6 years; 1 year of treatment, 5 years of follow-up [median of 5.3 years for final analysis])). 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 NCT00374322, which also lists 4 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 18 Aug 2014.

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