Trial Review

Registering a new trial?

To achieve prospective registration, we recommend submitting your trial for registration at the same time as ethics submission.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00374322




Registration number
NCT00374322
Ethics application status
Date submitted
7/09/2006
Date registered
11/09/2006
Date last updated
18/08/2014

Titles & IDs
Public title
Tykerb Evaluation After Chemotherapy (TEACH): Lapatinib Versus Placebo In Women With Early-Stage Breast Cancer
Scientific title
A Randomized, Double-blind, Multicenter, Placebo-controlled Study of Adjuvant Lapatinib (GW572016) in Women With Early-Stage ErbB2 Overexpressing Breast Cancer
Secondary ID [1] 0 0
EGF105485
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Neoplasms, Breast 0 0
Condition category
Condition code
Cancer 0 0 0 0
Breast

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - lapatinib
Other interventions - placebo

Placebo comparator: Placebo - 6 tablets daily for 12 months

Experimental: Lapatinib - Lapatinib 1500 mg (6 tablets) daily for 12 months


Treatment: Drugs: lapatinib
Lapatinib 1500 mg (6 tablets) daily for 12 months

Other interventions: placebo
6 tablets daily for 12 months
Intervention code [1] 0 0
Treatment: Drugs
Intervention code [2] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Number of Participants (Par.) With Any Recurrence of the Initial Disease, Second Primary Cancer, Contralateral Breast Cancer, or Death (Disease-free Survival [DFS])
Timepoint [1] 0 0
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 outcome [1] 0 0
Number of Participants Who Died (Overall Survival)
Timepoint [1] 0 0
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])
Secondary outcome [2] 0 0
Percentage of Participants With the Indicated Period of Recurrence-free Survival (Time to First Recurrence)
Timepoint [2] 0 0
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])
Secondary outcome [3] 0 0
Percentage of Participants With the Indicated Period of Distant Recurrence-free Survival (Time to Distant Recurrence)
Timepoint [3] 0 0
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])
Secondary outcome [4] 0 0
Time to Central Nervous System (CNS) Recurrence
Timepoint [4] 0 0
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])
Secondary outcome [5] 0 0
Number of Participants With CNS Recurrence
Timepoint [5] 0 0
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])
Secondary outcome [6] 0 0
Modified Disease-free Survival (MDFS)
Timepoint [6] 0 0
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)
Secondary outcome [7] 0 0
Number of Participants With Any Recurrence of the Initial Disease, Contralateral Breast Cancer, or Death (Disease-free Survival [DFS])
Timepoint [7] 0 0
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)
Secondary outcome [8] 0 0
Change From Baseline in Short Form-36 Version 2 (SF-36 v2) Scores for the Physical Component Summary (PCS)
Timepoint [8] 0 0
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)
Secondary outcome [9] 0 0
Change From Baseline in SF-36 v2 Scores for the Mental Component Summary (MCS)
Timepoint [9] 0 0
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)
Secondary outcome [10] 0 0
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)
Timepoint [10] 0 0
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)
Secondary outcome [11] 0 0
Number of Participants With Hematology Values Outside the Reference Range for the Indicated Parameters
Timepoint [11] 0 0
At Baseline and every 3 months thereafter up to Month 12/Early Withdrawal Visit
Secondary outcome [12] 0 0
Number of Participants With Clinical Chemistry Values Outside the Reference Range for the Indicated Parameters
Timepoint [12] 0 0
At Baseline and every 6 weeks thereafter up to Month 12/Early Withdrawal Visit
Secondary outcome [13] 0 0
Number of Participants With Non-laboratory Toxicities of the Indicated Toxicity Grades
Timepoint [13] 0 0
From the first dose of study treatment up to 12 months
Secondary outcome [14] 0 0
Number of Participants Experiencing Primary or Secondary Cardiac Events
Timepoint [14] 0 0
From the date of randomization up to 12 months
Secondary outcome [15] 0 0
Number of Participants With the Indicated Electrocardiogram (ECG) Findings
Timepoint [15] 0 0
Screening and Month 12/Early Withdrawal Visit

Eligibility
Key inclusion criteria
* 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.
* 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:
Minimum age
18 Years
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
* 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;
* 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;

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s

The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/08/2006
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/07/2013
Sample size
Target
Accrual to date
Final
3166
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC,WA
Recruitment hospital [1] 0 0
GSK Investigational Site - Campbelltown
Recruitment hospital [2] 0 0
GSK Investigational Site - Darlinghurst
Recruitment hospital [3] 0 0
GSK Investigational Site - Kogarah
Recruitment hospital [4] 0 0
GSK Investigational Site - Liverpool
Recruitment hospital [5] 0 0
GSK Investigational Site - North Sydney
Recruitment hospital [6] 0 0
GSK Investigational Site - Douglas
Recruitment hospital [7] 0 0
GSK Investigational Site - Herston
Recruitment hospital [8] 0 0
GSK Investigational Site - Redcliffe
Recruitment hospital [9] 0 0
GSK Investigational Site - South Brisbane
Recruitment hospital [10] 0 0
GSK Investigational Site - Bedford Park
Recruitment hospital [11] 0 0
GSK Investigational Site - Elizabeth Vale
Recruitment hospital [12] 0 0
GSK Investigational Site - Woodville
Recruitment hospital [13] 0 0
GSK Investigational Site - Box Hill
Recruitment hospital [14] 0 0
GSK Investigational Site - East Melbourne
Recruitment hospital [15] 0 0
GSK Investigational Site - Fitzroy
Recruitment hospital [16] 0 0
GSK Investigational Site - Footscray
Recruitment hospital [17] 0 0
GSK Investigational Site - Heidelberg
Recruitment hospital [18] 0 0
GSK Investigational Site - Parkville
Recruitment hospital [19] 0 0
GSK Investigational Site - Ringwood East
Recruitment hospital [20] 0 0
GSK Investigational Site - Wodonga
Recruitment hospital [21] 0 0
GSK Investigational Site - Nedlands
Recruitment hospital [22] 0 0
GSK Investigational Site - Perth
Recruitment postcode(s) [1] 0 0
2560 - Campbelltown
Recruitment postcode(s) [2] 0 0
2010 - Darlinghurst
Recruitment postcode(s) [3] 0 0
2217 - Kogarah
Recruitment postcode(s) [4] 0 0
2170 - Liverpool
Recruitment postcode(s) [5] 0 0
2060 - North Sydney
Recruitment postcode(s) [6] 0 0
4814 - Douglas
Recruitment postcode(s) [7] 0 0
4029 - Herston
Recruitment postcode(s) [8] 0 0
4020 - Redcliffe
Recruitment postcode(s) [9] 0 0
4101 - South Brisbane
Recruitment postcode(s) [10] 0 0
5042 - Bedford Park
Recruitment postcode(s) [11] 0 0
5112 - Elizabeth Vale
Recruitment postcode(s) [12] 0 0
5011 - Woodville
Recruitment postcode(s) [13] 0 0
3128 - Box Hill
Recruitment postcode(s) [14] 0 0
3002 - East Melbourne
Recruitment postcode(s) [15] 0 0
3065 - Fitzroy
Recruitment postcode(s) [16] 0 0
3011 - Footscray
Recruitment postcode(s) [17] 0 0
3084 - Heidelberg
Recruitment postcode(s) [18] 0 0
3050 - Parkville
Recruitment postcode(s) [19] 0 0
3135 - Ringwood East
Recruitment postcode(s) [20] 0 0
3690 - Wodonga
Recruitment postcode(s) [21] 0 0
6009 - Nedlands
Recruitment postcode(s) [22] 0 0
6000 - Perth
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
Country [2] 0 0
United States of America
State/province [2] 0 0
Arizona
Country [3] 0 0
United States of America
State/province [3] 0 0
Arkansas
Country [4] 0 0
United States of America
State/province [4] 0 0
California
Country [5] 0 0
United States of America
State/province [5] 0 0
Colorado
Country [6] 0 0
United States of America
State/province [6] 0 0
Connecticut
Country [7] 0 0
United States of America
State/province [7] 0 0
District of Columbia
Country [8] 0 0
United States of America
State/province [8] 0 0
Florida
Country [9] 0 0
United States of America
State/province [9] 0 0
Georgia
Country [10] 0 0
United States of America
State/province [10] 0 0
Illinois
Country [11] 0 0
United States of America
State/province [11] 0 0
Indiana
Country [12] 0 0
United States of America
State/province [12] 0 0
Iowa
Country [13] 0 0
United States of America
State/province [13] 0 0
Kansas
Country [14] 0 0
United States of America
State/province [14] 0 0
Kentucky
Country [15] 0 0
United States of America
State/province [15] 0 0
Louisiana
Country [16] 0 0
United States of America
State/province [16] 0 0
Maine
Country [17] 0 0
United States of America
State/province [17] 0 0
Maryland
Country [18] 0 0
United States of America
State/province [18] 0 0
Massachusetts
Country [19] 0 0
United States of America
State/province [19] 0 0
Michigan
Country [20] 0 0
United States of America
State/province [20] 0 0
Minnesota
Country [21] 0 0
United States of America
State/province [21] 0 0
Missouri
Country [22] 0 0
United States of America
State/province [22] 0 0
New Hampshire
Country [23] 0 0
United States of America
State/province [23] 0 0
New Jersey
Country [24] 0 0
United States of America
State/province [24] 0 0
New York
Country [25] 0 0
United States of America
State/province [25] 0 0
North Carolina
Country [26] 0 0
United States of America
State/province [26] 0 0
Ohio
Country [27] 0 0
United States of America
State/province [27] 0 0
Pennsylvania
Country [28] 0 0
United States of America
State/province [28] 0 0
South Carolina
Country [29] 0 0
United States of America
State/province [29] 0 0
Tennessee
Country [30] 0 0
United States of America
State/province [30] 0 0
Texas
Country [31] 0 0
United States of America
State/province [31] 0 0
Utah
Country [32] 0 0
United States of America
State/province [32] 0 0
Virginia
Country [33] 0 0
United States of America
State/province [33] 0 0
Washington
Country [34] 0 0
Argentina
State/province [34] 0 0
Buenos Aires
Country [35] 0 0
Argentina
State/province [35] 0 0
Córdova
Country [36] 0 0
Argentina
State/province [36] 0 0
Neuquén
Country [37] 0 0
Argentina
State/province [37] 0 0
Santa Fe
Country [38] 0 0
Argentina
State/province [38] 0 0
Ciudad Autónoma de Buenos Aires
Country [39] 0 0
Argentina
State/province [39] 0 0
Quilmes
Country [40] 0 0
Argentina
State/province [40] 0 0
San Miguel de Tucumán
Country [41] 0 0
Belgium
State/province [41] 0 0
Bruxelles
Country [42] 0 0
Brazil
State/province [42] 0 0
Minas Gerais
Country [43] 0 0
Brazil
State/province [43] 0 0
Rio Grande Do Sul
Country [44] 0 0
Brazil
State/province [44] 0 0
São Paulo
Country [45] 0 0
Brazil
State/province [45] 0 0
Rio de Janeiro
Country [46] 0 0
Canada
State/province [46] 0 0
Newfoundland and Labrador
Country [47] 0 0
Canada
State/province [47] 0 0
Nova Scotia
Country [48] 0 0
Canada
State/province [48] 0 0
Ontario
Country [49] 0 0
Canada
State/province [49] 0 0
Quebec
Country [50] 0 0
Canada
State/province [50] 0 0
Saskatchewan
Country [51] 0 0
Chile
State/province [51] 0 0
Región Metro De Santiago
Country [52] 0 0
Chile
State/province [52] 0 0
Valparaíso
Country [53] 0 0
China
State/province [53] 0 0
Guangdong
Country [54] 0 0
China
State/province [54] 0 0
Hubei
Country [55] 0 0
China
State/province [55] 0 0
Shandong
Country [56] 0 0
China
State/province [56] 0 0
Beijing
Country [57] 0 0
China
State/province [57] 0 0
Shanghai
Country [58] 0 0
China
State/province [58] 0 0
Tianjin
Country [59] 0 0
Croatia
State/province [59] 0 0
Osijek
Country [60] 0 0
Croatia
State/province [60] 0 0
Pula
Country [61] 0 0
Croatia
State/province [61] 0 0
Rijeka
Country [62] 0 0
Croatia
State/province [62] 0 0
Split
Country [63] 0 0
Croatia
State/province [63] 0 0
Zagreb
Country [64] 0 0
Czech Republic
State/province [64] 0 0
Brno
Country [65] 0 0
Czech Republic
State/province [65] 0 0
Prague 2
Country [66] 0 0
Czech Republic
State/province [66] 0 0
Praha 8
Country [67] 0 0
Denmark
State/province [67] 0 0
Aalborg
Country [68] 0 0
Denmark
State/province [68] 0 0
Copenhagen
Country [69] 0 0
Denmark
State/province [69] 0 0
Esbjerg
Country [70] 0 0
Denmark
State/province [70] 0 0
Herlev
Country [71] 0 0
Denmark
State/province [71] 0 0
Naestved
Country [72] 0 0
Denmark
State/province [72] 0 0
Odense
Country [73] 0 0
Denmark
State/province [73] 0 0
Roskilde
Country [74] 0 0
Denmark
State/province [74] 0 0
Vejle
Country [75] 0 0
France
State/province [75] 0 0
Angers
Country [76] 0 0
France
State/province [76] 0 0
Besançon
Country [77] 0 0
France
State/province [77] 0 0
Bordeaux
Country [78] 0 0
France
State/province [78] 0 0
Caen Cedex 05
Country [79] 0 0
France
State/province [79] 0 0
Clermont Ferrand
Country [80] 0 0
France
State/province [80] 0 0
Colmar Cedex
Country [81] 0 0
France
State/province [81] 0 0
Dijon Cedex
Country [82] 0 0
France
State/province [82] 0 0
Lille cedex
Country [83] 0 0
France
State/province [83] 0 0
Lille
Country [84] 0 0
France
State/province [84] 0 0
Lyon Cedex 08
Country [85] 0 0
France
State/province [85] 0 0
Lyon
Country [86] 0 0
France
State/province [86] 0 0
Marseille Cedex 09
Country [87] 0 0
France
State/province [87] 0 0
Montbeliard
Country [88] 0 0
France
State/province [88] 0 0
Montpellier Cedex 5
Country [89] 0 0
France
State/province [89] 0 0
Nantes cedex
Country [90] 0 0
France
State/province [90] 0 0
Nice Cedex 2
Country [91] 0 0
France
State/province [91] 0 0
Paris Cedex 15
Country [92] 0 0
France
State/province [92] 0 0
Reims
Country [93] 0 0
France
State/province [93] 0 0
Rennes
Country [94] 0 0
France
State/province [94] 0 0
Saint Grégoire
Country [95] 0 0
France
State/province [95] 0 0
Saint-Cloud
Country [96] 0 0
France
State/province [96] 0 0
Saint-Herblain
Country [97] 0 0
France
State/province [97] 0 0
Strasbourg
Country [98] 0 0
France
State/province [98] 0 0
Toulouse Cedex 3
Country [99] 0 0
France
State/province [99] 0 0
Toulouse Cedex 9
Country [100] 0 0
France
State/province [100] 0 0
Tourcoing
Country [101] 0 0
France
State/province [101] 0 0
Vandoeuvre-Les-Nancy
Country [102] 0 0
France
State/province [102] 0 0
Villejuif Cedex
Country [103] 0 0
France
State/province [103] 0 0
Villejuif
Country [104] 0 0
Germany
State/province [104] 0 0
Baden-Wuerttemberg
Country [105] 0 0
Germany
State/province [105] 0 0
Bayern
Country [106] 0 0
Germany
State/province [106] 0 0
Brandenburg
Country [107] 0 0
Germany
State/province [107] 0 0
Hessen
Country [108] 0 0
Germany
State/province [108] 0 0
Mecklenburg-Vorpommern
Country [109] 0 0
Germany
State/province [109] 0 0
Niedersachsen
Country [110] 0 0
Germany
State/province [110] 0 0
Nordrhein-Westfalen
Country [111] 0 0
Germany
State/province [111] 0 0
Rheinland-Pfalz
Country [112] 0 0
Germany
State/province [112] 0 0
Saarland
Country [113] 0 0
Germany
State/province [113] 0 0
Sachsen-Anhalt
Country [114] 0 0
Germany
State/province [114] 0 0
Sachsen
Country [115] 0 0
Germany
State/province [115] 0 0
Schleswig-Holstein
Country [116] 0 0
Germany
State/province [116] 0 0
Thueringen
Country [117] 0 0
Germany
State/province [117] 0 0
Berlin
Country [118] 0 0
Germany
State/province [118] 0 0
Bremen
Country [119] 0 0
Germany
State/province [119] 0 0
Hamburg
Country [120] 0 0
Greece
State/province [120] 0 0
Athens
Country [121] 0 0
Greece
State/province [121] 0 0
Chania
Country [122] 0 0
Greece
State/province [122] 0 0
Heraklion, Crete
Country [123] 0 0
Hong Kong
State/province [123] 0 0
Hong Kong
Country [124] 0 0
Hong Kong
State/province [124] 0 0
Shatin
Country [125] 0 0
Hong Kong
State/province [125] 0 0
Wanchai
Country [126] 0 0
Hungary
State/province [126] 0 0
Budapest
Country [127] 0 0
Hungary
State/province [127] 0 0
Gyor
Country [128] 0 0
Hungary
State/province [128] 0 0
Kaposvár
Country [129] 0 0
Hungary
State/province [129] 0 0
Kistarcsa
Country [130] 0 0
Hungary
State/province [130] 0 0
Pécs
Country [131] 0 0
Hungary
State/province [131] 0 0
Szeged
Country [132] 0 0
India
State/province [132] 0 0
Chennai
Country [133] 0 0
India
State/province [133] 0 0
Hyderabad
Country [134] 0 0
India
State/province [134] 0 0
Jaipur
Country [135] 0 0
India
State/province [135] 0 0
Mumbai
Country [136] 0 0
India
State/province [136] 0 0
New Delhi
Country [137] 0 0
India
State/province [137] 0 0
Pune
Country [138] 0 0
Israel
State/province [138] 0 0
Ashkelon
Country [139] 0 0
Israel
State/province [139] 0 0
Haifa
Country [140] 0 0
Israel
State/province [140] 0 0
Jerusalem
Country [141] 0 0
Israel
State/province [141] 0 0
Kfar Saba
Country [142] 0 0
Israel
State/province [142] 0 0
Ramat Gan
Country [143] 0 0
Israel
State/province [143] 0 0
Rehovot
Country [144] 0 0
Israel
State/province [144] 0 0
Tel Aviv
Country [145] 0 0
Italy
State/province [145] 0 0
Campania
Country [146] 0 0
Italy
State/province [146] 0 0
Emilia-Romagna
Country [147] 0 0
Italy
State/province [147] 0 0
Liguria
Country [148] 0 0
Italy
State/province [148] 0 0
Sardegna
Country [149] 0 0
Italy
State/province [149] 0 0
Umbria
Country [150] 0 0
Italy
State/province [150] 0 0
Veneto
Country [151] 0 0
Korea, Republic of
State/province [151] 0 0
Goyang-si, Gyeonggi-do
Country [152] 0 0
Korea, Republic of
State/province [152] 0 0
Seoul
Country [153] 0 0
Korea, Republic of
State/province [153] 0 0
songpa-gu, Seoul
Country [154] 0 0
Latvia
State/province [154] 0 0
Liepaja
Country [155] 0 0
Latvia
State/province [155] 0 0
Riga
Country [156] 0 0
Lithuania
State/province [156] 0 0
Kaunas
Country [157] 0 0
Lithuania
State/province [157] 0 0
Klaipeda
Country [158] 0 0
Lithuania
State/province [158] 0 0
Vilnius
Country [159] 0 0
Mexico
State/province [159] 0 0
Yucatán
Country [160] 0 0
Mexico
State/province [160] 0 0
Chihuahua
Country [161] 0 0
Mexico
State/province [161] 0 0
DF.
Country [162] 0 0
Mexico
State/province [162] 0 0
Mexico City
Country [163] 0 0
Mexico
State/province [163] 0 0
México D.F.
Country [164] 0 0
New Zealand
State/province [164] 0 0
Auckland
Country [165] 0 0
New Zealand
State/province [165] 0 0
Christchurch
Country [166] 0 0
New Zealand
State/province [166] 0 0
Hamilton
Country [167] 0 0
Peru
State/province [167] 0 0
Lima
Country [168] 0 0
Philippines
State/province [168] 0 0
Baguio City, Benguet
Country [169] 0 0
Philippines
State/province [169] 0 0
Cebu
Country [170] 0 0
Philippines
State/province [170] 0 0
Pasig City
Country [171] 0 0
Philippines
State/province [171] 0 0
Quezon City
Country [172] 0 0
Poland
State/province [172] 0 0
Bydgoszcz
Country [173] 0 0
Poland
State/province [173] 0 0
Krakow
Country [174] 0 0
Poland
State/province [174] 0 0
Olsztyn
Country [175] 0 0
Poland
State/province [175] 0 0
Torun
Country [176] 0 0
Poland
State/province [176] 0 0
Warszawa
Country [177] 0 0
Russian Federation
State/province [177] 0 0
Moscow
Country [178] 0 0
Russian Federation
State/province [178] 0 0
Ryazan
Country [179] 0 0
Russian Federation
State/province [179] 0 0
St. Petersburg
Country [180] 0 0
Russian Federation
State/province [180] 0 0
Yaroslavl
Country [181] 0 0
Slovakia
State/province [181] 0 0
Banska Bystrica
Country [182] 0 0
Slovakia
State/province [182] 0 0
Bardejov
Country [183] 0 0
Slovakia
State/province [183] 0 0
Bratislava
Country [184] 0 0
Slovakia
State/province [184] 0 0
Nitra
Country [185] 0 0
South Africa
State/province [185] 0 0
Western Province
Country [186] 0 0
South Africa
State/province [186] 0 0
Athlone Park, Amanzimtoti
Country [187] 0 0
South Africa
State/province [187] 0 0
Groenkloof
Country [188] 0 0
South Africa
State/province [188] 0 0
Kraaifontein
Country [189] 0 0
South Africa
State/province [189] 0 0
Overport
Country [190] 0 0
South Africa
State/province [190] 0 0
Parktown
Country [191] 0 0
South Africa
State/province [191] 0 0
Port Elizabeth
Country [192] 0 0
South Africa
State/province [192] 0 0
Sandton
Country [193] 0 0
South Africa
State/province [193] 0 0
Saxonwold, Johannesburg
Country [194] 0 0
Spain
State/province [194] 0 0
Alcorcon
Country [195] 0 0
Spain
State/province [195] 0 0
Barcelona
Country [196] 0 0
Spain
State/province [196] 0 0
Cáceres
Country [197] 0 0
Spain
State/province [197] 0 0
Girona
Country [198] 0 0
Spain
State/province [198] 0 0
Jaén
Country [199] 0 0
Spain
State/province [199] 0 0
Lerida
Country [200] 0 0
Spain
State/province [200] 0 0
Llobregat
Country [201] 0 0
Spain
State/province [201] 0 0
Madrid
Country [202] 0 0
Spain
State/province [202] 0 0
Mataró
Country [203] 0 0
Spain
State/province [203] 0 0
Orense
Country [204] 0 0
Spain
State/province [204] 0 0
Palma de Mallorca
Country [205] 0 0
Spain
State/province [205] 0 0
Santa Cruz de Tenerife
Country [206] 0 0
Spain
State/province [206] 0 0
Santander
Country [207] 0 0
Spain
State/province [207] 0 0
Santiago de Compostela
Country [208] 0 0
Spain
State/province [208] 0 0
Valencia
Country [209] 0 0
Spain
State/province [209] 0 0
Zaragoza
Country [210] 0 0
Ukraine
State/province [210] 0 0
Dnepropetrovsk
Country [211] 0 0
Ukraine
State/province [211] 0 0
Kyiv
Country [212] 0 0
Ukraine
State/province [212] 0 0
Lvov
Country [213] 0 0
Ukraine
State/province [213] 0 0
Uzhgorod
Country [214] 0 0
United Kingdom
State/province [214] 0 0
Essex
Country [215] 0 0
United Kingdom
State/province [215] 0 0
Lancashire
Country [216] 0 0
United Kingdom
State/province [216] 0 0
Surrey
Country [217] 0 0
United Kingdom
State/province [217] 0 0
Bournemouth
Country [218] 0 0
United Kingdom
State/province [218] 0 0
Edgbaston, Birmingham
Country [219] 0 0
United Kingdom
State/province [219] 0 0
Glasgow
Country [220] 0 0
United Kingdom
State/province [220] 0 0
Lindley
Country [221] 0 0
United Kingdom
State/province [221] 0 0
London
Country [222] 0 0
United Kingdom
State/province [222] 0 0
Maidstone
Country [223] 0 0
United Kingdom
State/province [223] 0 0
Manchester
Country [224] 0 0
United Kingdom
State/province [224] 0 0
Newcastle upon Tyne
Country [225] 0 0
United Kingdom
State/province [225] 0 0
Nottingham
Country [226] 0 0
United Kingdom
State/province [226] 0 0
Sheffield
Country [227] 0 0
United Kingdom
State/province [227] 0 0
Shrewsbury

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
GlaxoSmithKline
Address
Country

Ethics approval
Ethics application status

Summary
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 website
https://clinicaltrials.gov/study/NCT00374322
Trial related presentations / 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.
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.
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. Erratum In: Lancet Oncol. 2013 Feb;14(2):e47.
Public notes

Contacts
Principal investigator
Name 0 0
GSK Clinical Trials
Address 0 0
GlaxoSmithKline
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT00374322