Clinical trial NCT00374322: Tykerb Evaluation After Chemotherapy (TEACH): Lapatinib Versus Placebo In Women With Early-Stage Breast Cancer
Official title: A Randomized, Double-blind, Multicenter, Placebo-controlled Study of Adjuvant Lapatinib (GW572016) in Women With Early-Stage ErbB2 Overexpressing Breast Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Neoplasms, Breast
Keywords: Breast Cancer
ErbB2-overexpressing
early-stage breast cancer
adjuvant
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2006-09-11
Enrollment: 3166
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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:

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;

Primary outcomes:
measure: Number of Participants (Par.) With Any Recurrence of the Initial Disease, Second Primary Cancer, Contralateral Breast Cancer, or Death (Disease-free Survival [DFS])
timeFrame: 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:
measure: Number of Participants Who Died (Overall Survival)
timeFrame: 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])
measure: Percentage of Participants With the Indicated Period of Recurrence-free Survival (Time to First Recurrence)
timeFrame: 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])
measure: Percentage of Participants With the Indicated Period of Distant Recurrence-free Survival (Time to Distant Recurrence)
timeFrame: 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])
measure: Time to Central Nervous System (CNS) Recurrence
timeFrame: 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])
measure: Number of Participants With CNS Recurrence
timeFrame: 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])
measure: Modified Disease-free Survival (MDFS)
timeFrame: 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)
measure: Number of Participants With Any Recurrence of the Initial Disease, Contralateral Breast Cancer, or Death (Disease-free Survival [DFS])
timeFrame: 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)
measure: Change From Baseline in Short Form-36 Version 2 (SF-36 v2) Scores for the Physical Component Summary (PCS)
timeFrame: 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)
measure: Change From Baseline in SF-36 v2 Scores for the Mental Component Summary (MCS)
timeFrame: 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)
measure: 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)
timeFrame: 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)
measure: Number of Participants With Hematology Values Outside the Reference Range for the Indicated Parameters
timeFrame: At Baseline and every 3 months thereafter up to Month 12/Early Withdrawal Visit
measure: Number of Participants With Clinical Chemistry Values Outside the Reference Range for the Indicated Parameters
timeFrame: At Baseline and every 6 weeks thereafter up to Month 12/Early Withdrawal Visit
measure: Number of Participants With Non-laboratory Toxicities of the Indicated Toxicity Grades
timeFrame: From the first dose of study treatment up to 12 months
measure: Number of Participants Experiencing Primary or Secondary Cardiac Events
timeFrame: From the date of randomization up to 12 months
measure: Number of Participants With the Indicated Electrocardiogram (ECG) Findings
timeFrame: Screening and Month 12/Early Withdrawal Visit
Other outcomes:
Locations:
city: Tuscaloosa
country: United States
facility: GSK Investigational Site
state: Alabama
city: Phoenix
country: United States
facility: GSK Investigational Site
state: Arizona
city: Sedona
country: United States
facility: GSK Investigational Site
state: Arizona
city: Tucson
country: United States
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city: Little Rock
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city: Bakersfield
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facility: GSK Investigational Site
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city: Gilroy
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facility: GSK Investigational Site
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city: La Jolla
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facility: GSK Investigational Site
state: California
city: La Verne
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city: Palm Springs
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city: Torrington
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country: United States
facility: GSK Investigational Site
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city: Gainesville
country: United States
facility: GSK Investigational Site
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city: New Port Richey
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facility: GSK Investigational Site
state: Florida
city: Ocala
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state: Florida
city: Orlando
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city: Plantation
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city: Port St. Lucie
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city: Chicago
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city: Sioux City
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city: Cleveland
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city: Middletown
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city: Chattanooga
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state: Tennessee
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state: Virginia
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country: United States
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state: Virginia
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state: Washington
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facility: GSK Investigational Site
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facility: GSK Investigational Site
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facility: GSK Investigational Site
state: Buenos Aires
city: Ciudad Autonoma de Buenos Aires
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facility: GSK Investigational Site
state: Buenos Aires
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state: Neuquén
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facility: GSK Investigational Site
state: Santa Fe
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city: Quilmes
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city: San Miguel de Tucumán
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facility: GSK Investigational Site
city: Santa Fe
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facility: GSK Investigational Site
state: New South Wales
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facility: GSK Investigational Site
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state: New South Wales
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state: New South Wales
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country: Australia
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state: New South Wales
city: Douglas
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state: Queensland
city: Herston
country: Australia
facility: GSK Investigational Site
state: Queensland
city: Redcliffe
country: Australia
facility: GSK Investigational Site
state: Queensland
city: South Brisbane
country: Australia
facility: GSK Investigational Site
state: Queensland
city: Bedford Park
country: Australia
facility: GSK Investigational Site
state: South Australia
city: Elizabeth Vale
country: Australia
facility: GSK Investigational Site
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state: South Australia
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country: Australia
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country: Australia
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country: Australia
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country: Australia
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country: Australia
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city: Perth
country: Australia
facility: GSK Investigational Site
state: Western Australia
city: Bruxelles
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facility: GSK Investigational Site
city: Belo Horizonte
country: Brazil
facility: GSK Investigational Site
state: Minas Gerais
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country: Brazil
facility: GSK Investigational Site
state: Rio Grande Do Sul
city: Porto Alegre
country: Brazil
facility: GSK Investigational Site
state: Rio Grande Do Sul
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country: Brazil
facility: GSK Investigational Site
state: São Paulo
city: Rio de Janeiro
country: Brazil
facility: GSK Investigational Site
city: São Paulo
country: Brazil
facility: GSK Investigational Site
city: St. John's
country: Canada
facility: GSK Investigational Site
state: Newfoundland and Labrador
city: Halifax
country: Canada
facility: GSK Investigational Site
state: Nova Scotia
city: Barrie
country: Canada
facility: GSK Investigational Site
state: Ontario
city: Brampton
country: Canada
facility: GSK Investigational Site
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country: Canada
facility: GSK Investigational Site
state: Ontario
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country: Canada
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country: Canada
facility: GSK Investigational Site
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country: Canada
facility: GSK Investigational Site
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country: Canada
facility: GSK Investigational Site
state: Ontario
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country: Canada
facility: GSK Investigational Site
state: Ontario
city: Toronto
country: Canada
facility: GSK Investigational Site
state: Ontario
city: Toronto
country: Canada
facility: GSK Investigational Site
state: Ontario
city: Toronto
country: Canada
facility: GSK Investigational Site
state: Ontario
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country: Canada
facility: GSK Investigational Site
state: Quebec
city: Montreal
country: Canada
facility: GSK Investigational Site
state: Quebec
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country: Canada
facility: GSK Investigational Site
state: Saskatchewan
city: Quebec
country: Canada
facility: GSK Investigational Site
city: Santiago
country: Chile
facility: GSK Investigational Site
state: Región Metro De Santiago
city: Santiago
country: Chile
facility: GSK Investigational Site
state: Región Metro De Santiago
city: Santiago
country: Chile
facility: GSK Investigational Site
state: Región Metro De Santiago
city: Viña del Mar
country: Chile
facility: GSK Investigational Site
state: Valparaíso
city: Guangzhou
country: China
facility: GSK Investigational Site
state: Guangdong
city: Wuhan
country: China
facility: GSK Investigational Site
state: Hubei
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country: China
facility: GSK Investigational Site
state: Shandong
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country: China
facility: GSK Investigational Site
city: Beijing
country: China
facility: GSK Investigational Site
city: Beijing
country: China
facility: GSK Investigational Site
city: Shanghai
country: China
facility: GSK Investigational Site
city: Tianjin
country: China
facility: GSK Investigational Site
city: Osijek
country: Croatia
facility: GSK Investigational Site
city: Pula
country: Croatia
facility: GSK Investigational Site
city: Rijeka
country: Croatia
facility: GSK Investigational Site
city: Split
country: Croatia
facility: GSK Investigational Site
city: Zagreb
country: Croatia
facility: GSK Investigational Site
city: Brno
country: Czech Republic
facility: GSK Investigational Site
city: Prague 2
country: Czech Republic
facility: GSK Investigational Site
city: Praha 8
country: Czech Republic
facility: GSK Investigational Site
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country: Denmark
facility: GSK Investigational Site
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country: Denmark
facility: GSK Investigational Site
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country: Denmark
facility: GSK Investigational Site
city: Herlev
country: Denmark
facility: GSK Investigational Site
city: Naestved
country: Denmark
facility: GSK Investigational Site
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country: Denmark
facility: GSK Investigational Site
city: Roskilde
country: Denmark
facility: GSK Investigational Site
city: Vejle
country: Denmark
facility: GSK Investigational Site
city: Angers
country: France
facility: GSK Investigational Site
city: Besançon
country: France
facility: GSK Investigational Site
city: Bordeaux
country: France
facility: GSK Investigational Site
city: Caen Cedex 05
country: France
facility: GSK Investigational Site
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country: France
facility: GSK Investigational Site
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country: France
facility: GSK Investigational Site
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country: France
facility: GSK Investigational Site
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country: France
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country: France
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country: France
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country: France
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city: Montbeliard
country: France
facility: GSK Investigational Site
city: Montpellier Cedex 5
country: France
facility: GSK Investigational Site
city: Nantes cedex
country: France
facility: GSK Investigational Site
city: Nice Cedex 2
country: France
facility: GSK Investigational Site
city: Paris Cedex 15
country: France
facility: GSK Investigational Site
city: Reims
country: France
facility: GSK Investigational Site
city: Rennes
country: France
facility: GSK Investigational Site
city: Saint Grégoire
country: France
facility: GSK Investigational Site
city: Saint-Cloud
country: France
facility: GSK Investigational Site
city: Saint-Herblain
country: France
facility: GSK Investigational Site
city: Strasbourg
country: France
facility: GSK Investigational Site
city: Toulouse Cedex 3
country: France
facility: GSK Investigational Site
city: Toulouse Cedex 9
country: France
facility: GSK Investigational Site
city: Tourcoing
country: France
facility: GSK Investigational Site
city: Vandoeuvre-Les-Nancy
country: France
facility: GSK Investigational Site
city: Villejuif Cedex
country: France
facility: GSK Investigational Site
city: Villejuif
country: France
facility: GSK Investigational Site
city: Freiburg
country: Germany
facility: GSK Investigational Site
state: Baden-Wuerttemberg
city: Heidelberg
country: Germany
facility: GSK Investigational Site
state: Baden-Wuerttemberg
city: Konstanz
country: Germany
facility: GSK Investigational Site
state: Baden-Wuerttemberg
city: Mannheim
country: Germany
facility: GSK Investigational Site
state: Baden-Wuerttemberg
city: Mayen
country: Germany
facility: GSK Investigational Site
state: Baden-Wuerttemberg
city: Mutlangen
country: Germany
facility: GSK Investigational Site
state: Baden-Wuerttemberg
city: Rheinfelden
country: Germany
facility: GSK Investigational Site
state: Baden-Wuerttemberg
city: Schwetzingen
country: Germany
facility: GSK Investigational Site
state: Baden-Wuerttemberg
city: Singen
country: Germany
facility: GSK Investigational Site
state: Baden-Wuerttemberg
city: Stuttgart
country: Germany
facility: GSK Investigational Site
state: Baden-Wuerttemberg
city: Stuttgart
country: Germany
facility: GSK Investigational Site
state: Baden-Wuerttemberg
city: Tuebingen
country: Germany
facility: GSK Investigational Site
state: Baden-Wuerttemberg
city: Ulm
country: Germany
facility: GSK Investigational Site
state: Baden-Wuerttemberg
city: Amberg
country: Germany
facility: GSK Investigational Site
state: Bayern
city: Aschaffenburg
country: Germany
facility: GSK Investigational Site
state: Bayern
city: Bayreuth
country: Germany
facility: GSK Investigational Site
state: Bayern
city: Deggendorf
country: Germany
facility: GSK Investigational Site
state: Bayern
city: Ebersberg
country: Germany
facility: GSK Investigational Site
state: Bayern
city: Eggenfelden
country: Germany
facility: GSK Investigational Site
state: Bayern
city: Erlangen
country: Germany
facility: GSK Investigational Site
state: Bayern
city: Fuerth
country: Germany
facility: GSK Investigational Site
state: Bayern
city: Kempten
country: Germany
facility: GSK Investigational Site
state: Bayern
city: Krumbach
country: Germany
facility: GSK Investigational Site
state: Bayern
city: Marktredwitz
country: Germany
facility: GSK Investigational Site
state: Bayern
city: Memmingen
country: Germany
facility: GSK Investigational Site
state: Bayern
city: Muenchen
country: Germany
facility: GSK Investigational Site
state: Bayern
city: Muenchen
country: Germany
facility: GSK Investigational Site
state: Bayern
city: Muenchen
country: Germany
facility: GSK Investigational Site
state: Bayern
city: Muenchen
country: Germany
facility: GSK Investigational Site
state: Bayern
city: Muenchen
country: Germany
facility: GSK Investigational Site
state: Bayern
city: Rehling
country: Germany
facility: GSK Investigational Site
state: Bayern
city: Rosenheim
country: Germany
facility: GSK Investigational Site
state: Bayern
city: Roth
country: Germany
facility: GSK Investigational Site
state: Bayern
city: Schwandorf
country: Germany
facility: GSK Investigational Site
state: Bayern
city: Weiden
country: Germany
facility: GSK Investigational Site
state: Bayern
city: Cottbus
country: Germany
facility: GSK Investigational Site
state: Brandenburg
city: Fuerstenwalde
country: Germany
facility: GSK Investigational Site
state: Brandenburg
city: Frankfurt am Main
country: Germany
facility: GSK Investigational Site
state: Hessen
city: Frankfurt
country: Germany
facility: GSK Investigational Site
state: Hessen
city: Frankfurt
country: Germany
facility: GSK Investigational Site
state: Hessen
city: Frankfurt
country: Germany
facility: GSK Investigational Site
state: Hessen
city: Kassel
country: Germany
facility: GSK Investigational Site
state: Hessen
city: Kassel
country: Germany
facility: GSK Investigational Site
state: Hessen
city: Wiesbaden
country: Germany
facility: GSK Investigational Site
state: Hessen
city: Guestrow
country: Germany
facility: GSK Investigational Site
state: Mecklenburg-Vorpommern
city: Goslar
country: Germany
facility: GSK Investigational Site
state: Niedersachsen
city: Hannover
country: Germany
facility: GSK Investigational Site
state: Niedersachsen
city: Hildesheim
country: Germany
facility: GSK Investigational Site
state: Niedersachsen
city: Salzgitter
country: Germany
facility: GSK Investigational Site
state: Niedersachsen
city: Bochum
country: Germany
facility: GSK Investigational Site
state: Nordrhein-Westfalen
city: Bonn
country: Germany
facility: GSK Investigational Site
state: Nordrhein-Westfalen
city: Duesseldorf
country: Germany
facility: GSK Investigational Site
state: Nordrhein-Westfalen
city: Duisburg
country: Germany
facility: GSK Investigational Site
state: Nordrhein-Westfalen
city: Duisburg
country: Germany
facility: GSK Investigational Site
state: Nordrhein-Westfalen
city: Essen
country: Germany
facility: GSK Investigational Site
state: Nordrhein-Westfalen
city: Herne
country: Germany
facility: GSK Investigational Site
state: Nordrhein-Westfalen
city: Hilden
country: Germany
facility: GSK Investigational Site
state: Nordrhein-Westfalen
city: Koeln
country: Germany
facility: GSK Investigational Site
state: Nordrhein-Westfalen
city: Koeln
country: Germany
facility: GSK Investigational Site
state: Nordrhein-Westfalen
city: Muelheim
country: Germany
facility: GSK Investigational Site
state: Nordrhein-Westfalen
city: Porta Westfalica
country: Germany
facility: GSK Investigational Site
state: Nordrhein-Westfalen
city: Recklinghausen
country: Germany
facility: GSK Investigational Site
state: Nordrhein-Westfalen
city: Troisdorf
country: Germany
facility: GSK Investigational Site
state: Nordrhein-Westfalen
city: Velbert
country: Germany
facility: GSK Investigational Site
state: Nordrhein-Westfalen
city: Witten
country: Germany
facility: GSK Investigational Site
state: Nordrhein-Westfalen
city: Koblenz
country: Germany
facility: GSK Investigational Site
state: Rheinland-Pfalz
city: Mainz
country: Germany
facility: GSK Investigational Site
state: Rheinland-Pfalz
city: Homburg/Saar
country: Germany
facility: GSK Investigational Site
state: Saarland
city: Neunkirchen
country: Germany
facility: GSK Investigational Site
state: Saarland
city: Saarbruecken
country: Germany
facility: GSK Investigational Site
state: Saarland
city: Blankenburg
country: Germany
facility: GSK Investigational Site
state: Sachsen-Anhalt
city: Halle
country: Germany
facility: GSK Investigational Site
state: Sachsen-Anhalt
city: Magdeburg
country: Germany
facility: GSK Investigational Site
state: Sachsen-Anhalt
city: Magdeburg
country: Germany
facility: GSK Investigational Site
state: Sachsen-Anhalt
city: Stendal
country: Germany
facility: GSK Investigational Site
state: Sachsen-Anhalt
city: Chemnitz
country: Germany
facility: GSK Investigational Site
state: Sachsen
city: Dresden
country: Germany
facility: GSK Investigational Site
state: Sachsen
city: Kauschwitz
country: Germany
facility: GSK Investigational Site
state: Sachsen
city: Neustadt
country: Germany
facility: GSK Investigational Site
state: Sachsen
city: Spremberg
country: Germany
facility: GSK Investigational Site
state: Sachsen
city: Zittau
country: Germany
facility: GSK Investigational Site
state: Sachsen
city: Zwickau
country: Germany
facility: GSK Investigational Site
state: Sachsen
city: Kiel
country: Germany
facility: GSK Investigational Site
state: Schleswig-Holstein
city: Luebeck
country: Germany
facility: GSK Investigational Site
state: Schleswig-Holstein
city: Eisenach
country: Germany
facility: GSK Investigational Site
state: Thueringen
city: Jena
country: Germany
facility: GSK Investigational Site
state: Thueringen
city: Berlin
country: Germany
facility: GSK Investigational Site
city: Berlin
country: Germany
facility: GSK Investigational Site
city: Berlin
country: Germany
facility: GSK Investigational Site
city: Berlin
country: Germany
facility: GSK Investigational Site
city: Berlin
country: Germany
facility: GSK Investigational Site
city: Berlin
country: Germany
facility: GSK Investigational Site
city: Berlin
country: Germany
facility: GSK Investigational Site
city: Bremen
country: Germany
facility: GSK Investigational Site
city: Bremen
country: Germany
facility: GSK Investigational Site
city: Hamburg
country: Germany
facility: GSK Investigational Site
city: Hamburg
country: Germany
facility: GSK Investigational Site
city: Hamburg
country: Germany
facility: GSK Investigational Site
city: Athens
country: Greece
facility: GSK Investigational Site
city: Athens
country: Greece
facility: GSK Investigational Site
city: Athens
country: Greece
facility: GSK Investigational Site
city: Chania
country: Greece
facility: GSK Investigational Site
city: Heraklion, Crete
country: Greece
facility: GSK Investigational Site
city: Hong Kong
country: Hong Kong
facility: GSK Investigational Site
city: Shatin
country: Hong Kong
facility: GSK Investigational Site
city: Wanchai
country: Hong Kong
facility: GSK Investigational Site
city: Budapest
country: Hungary
facility: GSK Investigational Site
city: Budapest
country: Hungary
facility: GSK Investigational Site
city: Győr
country: Hungary
facility: GSK Investigational Site
city: Kaposvár
country: Hungary
facility: GSK Investigational Site
city: Kistarcsa
country: Hungary
facility: GSK Investigational Site
city: Pécs
country: Hungary
facility: GSK Investigational Site
city: Szeged
country: Hungary
facility: GSK Investigational Site
city: Chennai
country: India
facility: GSK Investigational Site
city: Hyderabad
country: India
facility: GSK Investigational Site
city: Jaipur
country: India
facility: GSK Investigational Site
city: Mumbai
country: India
facility: GSK Investigational Site
city: New Delhi
country: India
facility: GSK Investigational Site
city: Pune
country: India
facility: GSK Investigational Site
city: Ashkelon
country: Israel
facility: GSK Investigational Site
city: Haifa
country: Israel
facility: GSK Investigational Site
city: Jerusalem
country: Israel
facility: GSK Investigational Site
city: Kfar Saba
country: Israel
facility: GSK Investigational Site
city: Ramat Gan
country: Israel
facility: GSK Investigational Site
city: Rehovot
country: Israel
facility: GSK Investigational Site
city: Tel Aviv
country: Israel
facility: GSK Investigational Site
city: Avellino
country: Italy
facility: GSK Investigational Site
state: Campania
city: Piacenza
country: Italy
facility: GSK Investigational Site
state: Emilia-Romagna
city: Genova
country: Italy
facility: GSK Investigational Site
state: Liguria
city: Sassari
country: Italy
facility: GSK Investigational Site
state: Sardegna
city: Perugia
country: Italy
facility: GSK Investigational Site
state: Umbria
city: Negrar (Verona)
country: Italy
facility: GSK Investigational Site
state: Veneto
city: Goyang-si, Gyeonggi-do
country: Korea, Republic of
facility: GSK Investigational Site
city: Seoul
country: Korea, Republic of
facility: GSK Investigational Site
city: Seoul
country: Korea, Republic of
facility: GSK Investigational Site
city: songpa-gu, Seoul
country: Korea, Republic of
facility: GSK Investigational Site
city: Liepaja
country: Latvia
facility: GSK Investigational Site
city: Riga
country: Latvia
facility: GSK Investigational Site
city: Riga
country: Latvia
facility: GSK Investigational Site
city: Kaunas
country: Lithuania
facility: GSK Investigational Site
city: Klaipeda
country: Lithuania
facility: GSK Investigational Site
city: Vilnius
country: Lithuania
facility: GSK Investigational Site
city: Mérida
country: Mexico
facility: GSK Investigational Site
state: Yucatán
city: Chihuahua
country: Mexico
facility: GSK Investigational Site
city: DF.
country: Mexico
facility: GSK Investigational Site
city: Mexico City
country: Mexico
facility: GSK Investigational Site
city: México D.F.
country: Mexico
facility: GSK Investigational Site
city: Auckland
country: New Zealand
facility: GSK Investigational Site
city: Christchurch
country: New Zealand
facility: GSK Investigational Site
city: Hamilton
country: New Zealand
facility: GSK Investigational Site
city: Lima
country: Peru
facility: GSK Investigational Site
city: Lima
country: Peru
facility: GSK Investigational Site
city: Lima
country: Peru
facility: GSK Investigational Site
city: Baguio City, Benguet
country: Philippines
facility: GSK Investigational Site
city: Cebu
country: Philippines
facility: GSK Investigational Site
city: Pasig City
country: Philippines
facility: GSK Investigational Site
city: Quezon City
country: Philippines
facility: GSK Investigational Site
city: Bydgoszcz
country: Poland
facility: GSK Investigational Site
city: Krakow
country: Poland
facility: GSK Investigational Site
city: Olsztyn
country: Poland
facility: GSK Investigational Site
city: Olsztyn
country: Poland
facility: GSK Investigational Site
city: Torun
country: Poland
facility: GSK Investigational Site
city: Warszawa
country: Poland
facility: GSK Investigational Site
city: Moscow
country: Russian Federation
facility: GSK Investigational Site
city: Moscow
country: Russian Federation
facility: GSK Investigational Site
city: Moscow
country: Russian Federation
facility: GSK Investigational Site
city: Ryazan
country: Russian Federation
facility: GSK Investigational Site
city: St. Petersburg
country: Russian Federation
facility: GSK Investigational Site
city: St. Petersburg
country: Russian Federation
facility: GSK Investigational Site
city: Yaroslavl
country: Russian Federation
facility: GSK Investigational Site
city: Banska Bystrica
country: Slovakia
facility: GSK Investigational Site
city: Bardejov
country: Slovakia
facility: GSK Investigational Site
city: Bratislava
country: Slovakia
facility: GSK Investigational Site
city: Nitra
country: Slovakia
facility: GSK Investigational Site
city: Tygerberg
country: South Africa
facility: GSK Investigational Site
state: Western Province
city: Athlone Park, Amanzimtoti
country: South Africa
facility: GSK Investigational Site
city: Groenkloof
country: South Africa
facility: GSK Investigational Site
city: Kraaifontein
country: South Africa
facility: GSK Investigational Site
city: Overport
country: South Africa
facility: GSK Investigational Site
city: Parktown
country: South Africa
facility: GSK Investigational Site
city: Port Elizabeth
country: South Africa
facility: GSK Investigational Site
city: Sandton
country: South Africa
facility: GSK Investigational Site
city: Saxonwold, Johannesburg
country: South Africa
facility: GSK Investigational Site
city: Alcorcon
country: Spain
facility: GSK Investigational Site
city: Barcelona
country: Spain
facility: GSK Investigational Site
city: Barcelona
country: Spain
facility: GSK Investigational Site
city: Cáceres
country: Spain
facility: GSK Investigational Site
city: Girona
country: Spain
facility: GSK Investigational Site
city: Jaén
country: Spain
facility: GSK Investigational Site
city: Lerida
country: Spain
facility: GSK Investigational Site
city: Llobregat
country: Spain
facility: GSK Investigational Site
city: Madrid
country: Spain
facility: GSK Investigational Site
city: Madrid
country: Spain
facility: GSK Investigational Site
city: Mataró
country: Spain
facility: GSK Investigational Site
city: Orense
country: Spain
facility: GSK Investigational Site
city: Palma de Mallorca
country: Spain
facility: GSK Investigational Site
city: Palma de Mallorca
country: Spain
facility: GSK Investigational Site
city: Santa Cruz de Tenerife
country: Spain
facility: GSK Investigational Site
city: Santander
country: Spain
facility: GSK Investigational Site
city: Santiago de Compostela
country: Spain
facility: GSK Investigational Site
city: Valencia
country: Spain
facility: GSK Investigational Site
city: Zaragoza
country: Spain
facility: GSK Investigational Site
city: Dnepropetrovsk
country: Ukraine
facility: GSK Investigational Site
city: Kyiv
country: Ukraine
facility: GSK Investigational Site
city: Lvov
country: Ukraine
facility: GSK Investigational Site
city: Uzhgorod
country: Ukraine
facility: GSK Investigational Site
city: Chelmsford
country: United Kingdom
facility: GSK Investigational Site
state: Essex
city: Manchester
country: United Kingdom
facility: GSK Investigational Site
state: Lancashire
city: Sutton
country: United Kingdom
facility: GSK Investigational Site
state: Surrey
city: Bournemouth
country: United Kingdom
facility: GSK Investigational Site
city: Edgbaston, Birmingham
country: United Kingdom
facility: GSK Investigational Site
city: Glasgow
country: United Kingdom
facility: GSK Investigational Site
city: Lindley
country: United Kingdom
facility: GSK Investigational Site
city: London
country: United Kingdom
facility: GSK Investigational Site
city: London
country: United Kingdom
facility: GSK Investigational Site
city: London
country: United Kingdom
facility: GSK Investigational Site
city: London
country: United Kingdom
facility: GSK Investigational Site
city: Maidstone
country: United Kingdom
facility: GSK Investigational Site
city: Manchester
country: United Kingdom
facility: GSK Investigational Site
city: Newcastle upon Tyne
country: United Kingdom
facility: GSK Investigational Site
city: Nottingham
country: United Kingdom
facility: GSK Investigational Site
city: Sheffield
country: United Kingdom
facility: GSK Investigational Site
city: Shrewsbury
country: United Kingdom
facility: GSK Investigational Site
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.