Tykerb Evaluation After Chemotherapy (TEACH): Lapatinib Versus Placebo In Women With Early-Stage Breast Cancer
A Randomized, Double-blind, Multicenter, Placebo-controlled Study of Adjuvant Lapatinib (GW572016) in Women With Early-Stage ErbB2 Overexpressing Breast Cancer
1 other identifier
interventional
3,166
33 countries
439
Brief 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 of disease.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Aug 2006
Longer than P75 for phase_3
439 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2006
CompletedFirst Submitted
Initial submission to the registry
September 7, 2006
CompletedFirst Posted
Study publicly available on registry
September 11, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2013
CompletedResults Posted
Study results publicly available
August 18, 2014
CompletedAugust 18, 2014
July 1, 2014
5.1 years
September 7, 2006
July 17, 2014
August 14, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (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.
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)
Number of Participants Who Died (Overall Survival)
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])
Percentage of Participants With the Indicated Period of Recurrence-free Survival (Time to First Recurrence)
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])
Percentage of Participants With the Indicated Period of Distant Recurrence-free Survival (Time to Distant Recurrence)
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])
Time to Central Nervous System (CNS) Recurrence
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])
Number of Participants With CNS Recurrence
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])
- +10 more secondary outcomes
Study Arms (2)
Placebo
PLACEBO COMPARATOR6 tablets daily for 12 months
Lapatinib
EXPERIMENTALLapatinib 1500 mg (6 tablets) daily for 12 months
Interventions
Eligibility Criteria
You may qualify if:
- 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.
- 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.
- +15 more criteria
You may not qualify if:
- 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;
- 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;
- +2 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- GlaxoSmithKlinelead
Study Sites (439)
GSK Investigational Site
Tuscaloosa, Alabama, 35406, United States
GSK Investigational Site
Phoenix, Arizona, 85012, United States
GSK Investigational Site
Sedona, Arizona, 86336, United States
GSK Investigational Site
Tucson, Arizona, 85715, United States
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Fayetteville, Arkansas, 72703, United States
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Jonesboro, Arkansas, 72401, United States
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Little Rock, Arkansas, 72205, United States
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Anaheim, California, 92801, United States
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Bakersfield, California, 93309, United States
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Gilroy, California, 95020, United States
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La Jolla, California, 92037, United States
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La Verne, California, 91750, United States
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Palm Springs, California, 92262, United States
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Rancho Mirage, California, 92270, United States
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Denver, Colorado, 80220, United States
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Fairfield, Connecticut, 06824, United States
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Norwalk, Connecticut, 06856, United States
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Torrington, Connecticut, 06790, United States
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Washington D.C., District of Columbia, 20007, United States
GSK Investigational Site
Washington D.C., District of Columbia, 20010, United States
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Boca Raton, Florida, 33428, United States
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Boynton Beach, Florida, 33437, United States
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Gainesville, Florida, 32605, United States
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New Port Richey, Florida, 34655, United States
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Ocala, Florida, 34474, United States
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Orlando, Florida, 32806, United States
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Plantation, Florida, 33324, United States
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Port Saint Lucie, Florida, 34952, United States
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Augusta, Georgia, 30901, United States
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Marietta, Georgia, 30060, United States
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Chicago, Illinois, 60611-2906, United States
GSK Investigational Site
Chicago, Illinois, 60611, United States
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Joliet, Illinois, 60435, United States
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Park Ridge, Illinois, 60068, United States
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Indianapolis, Indiana, 46219, United States
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Ames, Iowa, 50010, United States
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Sioux City, Iowa, 51101-1733, United States
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Wichita, Kansas, 67214, United States
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Louisville, Kentucky, 40245, United States
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Marrero, Louisiana, 70072, United States
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Scarborough, Maine, 4074, United States
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Bethesda, Maryland, 20817, United States
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Boston, Massachusetts, 02114, United States
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Danvers, Massachusetts, 01923, United States
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Newton, Massachusetts, 02462, United States
GSK Investigational Site
Kalamazoo, Michigan, 49048, United States
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Duluth, Minnesota, 55805, United States
GSK Investigational Site
Edina, Minnesota, 55435, United States
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Minneapolis, Minnesota, 55404, United States
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Robbinsdale, Minnesota, 55422, United States
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Columbia, Missouri, 65201, United States
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Kansas City, Missouri, 64118, United States
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Saint Joseph, Missouri, 64507, United States
GSK Investigational Site
St Louis, Missouri, 63109, United States
GSK Investigational Site
St Louis, Missouri, 63141, United States
GSK Investigational Site
Hooksett, New Hampshire, 03106, United States
GSK Investigational Site
Cherry Hill, New Jersey, 08003, United States
GSK Investigational Site
Morristown, New Jersey, 07962, United States
GSK Investigational Site
Paramus, New Jersey, 07652, United States
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Sparta, New Jersey, 07871, United States
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Albany, New York, 12206, United States
GSK Investigational Site
East Setauket, New York, 11733, United States
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Mount Kisco, New York, 10590, United States
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New York, New York, 10003, United States
GSK Investigational Site
New York, New York, 10016, United States
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Rochester, New York, 14623, United States
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Charleston, North Carolina, 29406, United States
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Gastonia, North Carolina, 28054, United States
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Greensboro, North Carolina, 27403, United States
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Hickory, North Carolina, 28602, United States
GSK Investigational Site
Cleveland, Ohio, 44106, United States
GSK Investigational Site
Cleveland, Ohio, 44195, United States
GSK Investigational Site
Columbus, Ohio, 43215, United States
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Middletown, Ohio, 45042, United States
GSK Investigational Site
Drexel Hill, Pennsylvania, 19026, United States
GSK Investigational Site
Philadelphia, Pennsylvania, 19107, United States
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Charleston, South Carolina, 29414, United States
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Chattanooga, Tennessee, 37403, United States
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Germantown, Tennessee, 38138, United States
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Memphis, Tennessee, 38120, United States
GSK Investigational Site
Austin, Texas, 78705, United States
GSK Investigational Site
Austin, Texas, 78759, United States
GSK Investigational Site
Bedford, Texas, 76022, United States
GSK Investigational Site
Dallas, Texas, 75230, United States
GSK Investigational Site
Dallas, Texas, 75231, United States
GSK Investigational Site
Dallas, Texas, 75246, United States
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Duncanville, Texas, 75137, United States
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El Paso, Texas, 79902, United States
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Fort Worth, Texas, 76104, United States
GSK Investigational Site
Houston, Texas, 77024, United States
GSK Investigational Site
Houston, Texas, 77030, United States
GSK Investigational Site
Round Rock, Texas, 78681, United States
GSK Investigational Site
San Antonio, Texas, 78229, United States
GSK Investigational Site
Tyler, Texas, 75702, United States
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Waco, Texas, 76712, United States
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Ogden, Utah, 84403, United States
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Chesapeake, Virginia, 23320, United States
GSK Investigational Site
Fairfax, Virginia, 22031, United States
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Richlands, Virginia, 24641, United States
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Kirkland, Washington, United States
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Seattle, Washington, 98104, United States
GSK Investigational Site
Vancouver, Washington, 98684, United States
GSK Investigational Site
Yakima, Washington, 98902, United States
GSK Investigational Site
Capital Federal, Buenos Aires, C1405CUB, Argentina
GSK Investigational Site
Ciudad Autonoma de Buenos Aires, Buenos Aires, C1185AAT, Argentina
GSK Investigational Site
Ciudad Autonoma de Buenos Aires, Buenos Aires, C1405BCH, Argentina
GSK Investigational Site
Córdoba, Córdoba Province, X5006HBF, Argentina
GSK Investigational Site
Neuquén, Neuquén Province, Q8300HDH, Argentina
GSK Investigational Site
Rosario, Santa Fe Province, S2000KZE, Argentina
GSK Investigational Site
Santa Fe, Santa Fe Province, 3000, Argentina
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Buenos Aires, C1417DTN, Argentina
GSK Investigational Site
Quilmes, 1878, Argentina
GSK Investigational Site
San Miguel de Tucumán, T4000IAK, Argentina
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Campbelltown, New South Wales, 2560, Australia
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Darlinghurst, New South Wales, 2010, Australia
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Kogarah, New South Wales, 2217, Australia
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Liverpool, New South Wales, 2170, Australia
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North Sydney, New South Wales, 2060, Australia
GSK Investigational Site
Douglas, Queensland, 4814, Australia
GSK Investigational Site
Herston, Queensland, 4029, Australia
GSK Investigational Site
Redcliffe, Queensland, 4020, Australia
GSK Investigational Site
South Brisbane, Queensland, 4101, Australia
GSK Investigational Site
Bedford Park, South Australia, 5042, Australia
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Elizabeth Vale, South Australia, 5112, Australia
GSK Investigational Site
Woodville, South Australia, 5011, Australia
GSK Investigational Site
Box Hill, Victoria, 3128, Australia
GSK Investigational Site
East Melbourne, Victoria, 3002, Australia
GSK Investigational Site
Fitzroy, Victoria, 3065, Australia
GSK Investigational Site
Footscray, Victoria, 3011, Australia
GSK Investigational Site
Heidelberg, Victoria, 3084, Australia
GSK Investigational Site
Parkville, Victoria, 3050, Australia
GSK Investigational Site
Ringwood East, Victoria, 3135, Australia
GSK Investigational Site
Wodonga, Victoria, 3690, Australia
GSK Investigational Site
Nedlands, Western Australia, 6009, Australia
GSK Investigational Site
Perth, Western Australia, 6000, Australia
GSK Investigational Site
Brussels, 1000, Belgium
GSK Investigational Site
Belo Horizonte, Minas Gerais, 30.140-001, Brazil
GSK Investigational Site
Rio de Janeiro, Rio de Janeiro, 21941-913, Brazil
GSK Investigational Site
Porto Alegre, Rio Grande do Sul, 90020-090, Brazil
GSK Investigational Site
Porto Alegre, Rio Grande do Sul, 90610 000, Brazil
GSK Investigational Site
Santo André, São Paulo, 09060-670, Brazil
GSK Investigational Site
São Paulo, São Paulo, 03102-002, Brazil
GSK Investigational Site
St. John's, Newfoundland and Labrador, A1B 3V6, Canada
GSK Investigational Site
Halifax, Nova Scotia, B3H 1V7, Canada
GSK Investigational Site
Barrie, Ontario, L4M 6M2, Canada
GSK Investigational Site
Brampton, Ontario, L6W 2Z8, Canada
GSK Investigational Site
Kingston, Ontario, K7L 5P9, Canada
GSK Investigational Site
London, Ontario, N6A 4L6, Canada
GSK Investigational Site
Mississauga, Ontario, L5M 2N1, Canada
GSK Investigational Site
Oshawa, Ontario, L1G 2B9, Canada
GSK Investigational Site
Ottawa, Ontario, K1H 8L6, Canada
GSK Investigational Site
Toronto, Ontario, M4C 3E7, Canada
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Toronto, Ontario, M4N 3M5, Canada
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Toronto, Ontario, M5B 1W8, Canada
GSK Investigational Site
Toronto, Ontario, M6R 1B5, Canada
GSK Investigational Site
Greenfield Park, Quebec, J4V 2H1, Canada
GSK Investigational Site
Montreal, Quebec, H3T 1E2, Canada
GSK Investigational Site
Québec, Quebec, G1S 4L8, Canada
GSK Investigational Site
Saskatoon, Saskatchewan, S7N 4H4, Canada
GSK Investigational Site
Viña del Mar, Región de Valparaíso, 254-0364, Chile
GSK Investigational Site
Santiago, Región Metro de Santiago, 750 1088, Chile
GSK Investigational Site
Santiago, Región Metro de Santiago, 7500921, Chile
GSK Investigational Site
Santiago, Región Metro de Santiago, 7591046, Chile
GSK Investigational Site
Guangzhou, Guangdong, 510060, China
GSK Investigational Site
Wuhan, Hubei, 430030, China
GSK Investigational Site
Jinan, Shandong, 250117, China
GSK Investigational Site
Beijing, 100021, China
GSK Investigational Site
Beijing, 100036, China
GSK Investigational Site
Beijing, 100071, China
GSK Investigational Site
Shanghai, 200032, China
GSK Investigational Site
Tianjin, 300060, China
GSK Investigational Site
Osijek, 31000, Croatia
GSK Investigational Site
Pula, 52 100, Croatia
GSK Investigational Site
Rijeka, 51000, Croatia
GSK Investigational Site
Split, 21000, Croatia
GSK Investigational Site
Zagreb, 10 000, Croatia
GSK Investigational Site
Brno, 656 53, Czechia
GSK Investigational Site
Prague, 121 00, Czechia
GSK Investigational Site
Prague, 180 00, Czechia
GSK Investigational Site
Aalborg, 9100, Denmark
GSK Investigational Site
Copenhagen, DK-2100, Denmark
GSK Investigational Site
Esbjerg, 6700, Denmark
GSK Investigational Site
Herlev, DK-2730, Denmark
GSK Investigational Site
Næstved, 4700, Denmark
GSK Investigational Site
Odense, 5000, Denmark
GSK Investigational Site
Roskilde, 4000, Denmark
GSK Investigational Site
Vejle, 7100, Denmark
GSK Investigational Site
Angers, 49933, France
GSK Investigational Site
Besançon, 25030, France
GSK Investigational Site
Bordeaux, 33000, France
GSK Investigational Site
Caen, 14076, France
GSK Investigational Site
Clermont-Ferrand, 63000, France
GSK Investigational Site
Colmar, 68024, France
GSK Investigational Site
Dijon, 21079, France
GSK Investigational Site
Lille, 59000, France
GSK Investigational Site
Lille, 59020, France
GSK Investigational Site
Lyon, 69008, France
GSK Investigational Site
Lyon, 69373, France
GSK Investigational Site
Marseille, 13273, France
GSK Investigational Site
Montbéliard, 25200, France
GSK Investigational Site
Montpellier, 34298, France
GSK Investigational Site
Nantes, 44202, France
GSK Investigational Site
Nice, 06189, France
GSK Investigational Site
Paris, 75908, France
GSK Investigational Site
Reims, 51100, France
GSK Investigational Site
Rennes, 35042, France
GSK Investigational Site
Saint-Cloud, 92210, France
GSK Investigational Site
Saint-Grégoire, 35760, France
GSK Investigational Site
Saint-Herblain, 44805, France
GSK Investigational Site
Strasbourg, 67000, France
GSK Investigational Site
Toulouse, 31059, France
GSK Investigational Site
Toulouse, 31076, France
GSK Investigational Site
Tourcoing, 59200, France
GSK Investigational Site
Vandœuvre-lès-Nancy, 54511, France
GSK Investigational Site
Villejuif, 94804, France
GSK Investigational Site
Villejuif, 94805, France
GSK Investigational Site
Freiburg im Breisgau, Baden-Wurttemberg, 79106, Germany
GSK Investigational Site
Heidelberg, Baden-Wurttemberg, 69115, Germany
GSK Investigational Site
Konstanz, Baden-Wurttemberg, 78464, Germany
GSK Investigational Site
Mannheim, Baden-Wurttemberg, 68161, Germany
GSK Investigational Site
Mayen, Baden-Wurttemberg, 56727, Germany
GSK Investigational Site
Mutlangen, Baden-Wurttemberg, 73557, Germany
GSK Investigational Site
Rheinfelden, Baden-Wurttemberg, 79618, Germany
GSK Investigational Site
Schwetzingen, Baden-Wurttemberg, 68723, Germany
GSK Investigational Site
Singen, Baden-Wurttemberg, 78224, Germany
GSK Investigational Site
Stuttgart, Baden-Wurttemberg, 70190, Germany
GSK Investigational Site
Stuttgart, Baden-Wurttemberg, 70376, Germany
GSK Investigational Site
Tübingen, Baden-Wurttemberg, 72076, Germany
GSK Investigational Site
Ulm, Baden-Wurttemberg, 89075, Germany
GSK Investigational Site
Amberg, Bavaria, 92224, Germany
GSK Investigational Site
Aschaffenburg, Bavaria, 63739, Germany
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Bayreuth, Bavaria, 95445, Germany
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Deggendorf, Bavaria, 94469, Germany
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Ebersberg, Bavaria, 85560, Germany
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Eggenfelden, Bavaria, 84307, Germany
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Erlangen, Bavaria, 91054, Germany
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Fürth, Bavaria, 90766, Germany
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Kempten (Allgäu), Bavaria, 87439, Germany
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Krumbach, Bavaria, 86381, Germany
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Marktredwitz, Bavaria, 95615, Germany
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Memmingen, Bavaria, 87700, Germany
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Munich, Bavaria, 80331, Germany
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Munich, Bavaria, 80335, Germany
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Munich, Bavaria, 80337, Germany
GSK Investigational Site
Munich, Bavaria, 80637, Germany
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Munich, Bavaria, 81377, Germany
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Rehling, Bavaria, 86508, Germany
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Rosenheim, Bavaria, 83022, Germany
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Roth, Bavaria, 91154, Germany
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Schwandorf in Bayern, Bavaria, 92421, Germany
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Weiden, Bavaria, 92637, Germany
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Cottbus, Brandenburg, 03046, Germany
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Fürstenwalde, Brandenburg, 15517, Germany
GSK Investigational Site
Bremen, City state Bremen, 28177, Germany
GSK Investigational Site
Bremen, City state Bremen, 28209, Germany
GSK Investigational Site
Hamburg, Hamburg, 20246, Germany
GSK Investigational Site
Hamburg, Hamburg, 22081, Germany
GSK Investigational Site
Hamburg, Hamburg, 22457, Germany
GSK Investigational Site
Frankfurt am Main, Hesse, 60389, Germany
GSK Investigational Site
Frankfurt am Main, Hesse, 60590, Germany
GSK Investigational Site
Frankfurt am Main, Hesse, 60596, Germany
GSK Investigational Site
Frankfurt am Main, Hesse, 65929, Germany
GSK Investigational Site
Kassel, Hesse, 34117, Germany
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Kassel, Hesse, 34131, Germany
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Wiesbaden, Hesse, 65191, Germany
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Goslar, Lower Saxony, 38642, Germany
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Hanover, Lower Saxony, 30625, Germany
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Hildesheim, Lower Saxony, 31134, Germany
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Salzgitter, Lower Saxony, 38226, Germany
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Güstrow, Mecklenburg-Vorpommern, 18273, Germany
GSK Investigational Site
Bochum, North Rhine-Westphalia, 44799, Germany
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Bonn, North Rhine-Westphalia, 53113, Germany
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Cologne, North Rhine-Westphalia, 50677, Germany
GSK Investigational Site
Cologne, North Rhine-Westphalia, 50937, Germany
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Duisburg, North Rhine-Westphalia, 47051, Germany
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Duisburg, North Rhine-Westphalia, 47166, Germany
GSK Investigational Site
Düsseldorf, North Rhine-Westphalia, 40235, Germany
GSK Investigational Site
Essen, North Rhine-Westphalia, 45130, Germany
GSK Investigational Site
Herne, North Rhine-Westphalia, 44623, Germany
GSK Investigational Site
Hilden, North Rhine-Westphalia, 40724, Germany
GSK Investigational Site
Mülheim, North Rhine-Westphalia, 45473, Germany
GSK Investigational Site
Porta Westfalica, North Rhine-Westphalia, 32457, Germany
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Recklinghausen, North Rhine-Westphalia, 45657, Germany
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Troisdorf, North Rhine-Westphalia, 53840, Germany
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Velbert, North Rhine-Westphalia, 42551, Germany
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Witten, North Rhine-Westphalia, 58452, Germany
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Koblenz, Rhineland-Palatinate, 56068, Germany
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Mainz, Rhineland-Palatinate, 55131, Germany
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Homburg/Saar, Saarland, 66421, Germany
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Neunkirchen, Saarland, 66538, Germany
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Dresden, Saxony, 01307, Germany
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Kauschwitz, Saxony, 08525, Germany
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Blankenburg, Saxony-Anhalt, 38889, Germany
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Berlin, State of Berlin, 13125, Germany
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Berlin, State of Berlin, 13156, Germany
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Athens, 115 27, Greece
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Athens, 185 37, Greece
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Chania, 73100, Greece
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Heraklion, Crete, 71110, Greece
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Mumbai, 400012, India
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Pune, 411001, India
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Ashkelon, 78278, Israel
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Jerusalem, 91120, Israel
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Kfar Saba, 44281, Israel
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Ramat Gan, 52621, Israel
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Rehovot, 76100, Israel
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Tel Aviv, 64239, Israel
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Avellino, Campania, 83100, Italy
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Piacenza, Emilia-Romagna, 29100, Italy
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Genoa, Liguria, 16132, Italy
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Negrar (Verona), Veneto, 37024, Italy
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Mexico City, CP 14080, Mexico
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Alcorcón, 28922, Spain
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Related Publications (4)
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.
BACKGROUNDBoyle 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.
PMID: 25752740DERIVEDSchaid 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.
PMID: 24687830DERIVEDGoss 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.
PMID: 23234763DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- GSK Response Center
- Organization
- GlaxoSmithKline
Study Officials
- STUDY DIRECTOR
GSK Clinical Trials
GlaxoSmithKline
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 7, 2006
First Posted
September 11, 2006
Study Start
August 1, 2006
Primary Completion
September 1, 2011
Study Completion
July 1, 2013
Last Updated
August 18, 2014
Results First Posted
August 18, 2014
Record last verified: 2014-07