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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00374322
First received: September 7, 2006
Last updated: August 14, 2014
Last verified: July 2014
  Purpose

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.


Condition Intervention Phase
Neoplasms, Breast
Drug: lapatinib
Other: placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: A Randomized, Double-blind, Multicenter, Placebo-controlled Study of Adjuvant Lapatinib (GW572016) in Women With Early-Stage ErbB2 Overexpressing Breast Cancer

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • Number of Participants (Par.) With Any Recurrence of the Initial Disease, Second Primary Cancer, Contralateral Breast Cancer, or Death (Disease-free Survival [DFS]) [ Time Frame: From randomization until date of the first occurrence of an objective disease recurrence, a second primary cancer, or death from any cause (assessed up to 6 years; 1 year of treatment, 5 years of follow-up [median of 5.3 years for final analysis]) ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Number of Participants Who Died (Overall Survival) [ Time Frame: 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]) ] [ Designated as safety issue: No ]
    Overall Survival (OS) is defined as the time from randomization until death from any cause. Data are presented as the number of participants who died. For participants who did not die, time to death was censored at the last date the participant was known to be alive.

  • Percentage of Participants With the Indicated Period of Recurrence-free Survival (Time to First Recurrence) [ Time Frame: 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]) ] [ Designated as safety issue: No ]
    Recurrence is defined as experiencing a recurrence of initial disease or contralateral breast cancer after randomization. Time to first recurrence is defined as the interval between the date of randomization and the date of the first occurrence of an objective disease recurrence or contralateral breast cancer. Time to first recurrence included the first occurrence at one of the following sites as an event: local recurrence following mastectomy; local recurrence in ipsilateral breast following lumpectomy; regional recurrence; distant recurrence; contralateral breast cancer, including ductal carcinoma in situ (DCIS).

  • Percentage of Participants With the Indicated Period of Distant Recurrence-free Survival (Time to Distant Recurrence) [ Time Frame: 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]) ] [ Designated as safety issue: No ]
    Distant recurrence (metastatic disease) is defined as a tumor in any area of the body not including those defined as local or regional recurrence. Sites of distant recurrence include: skin, subcutaneous tissue, and lymph nodes (excluding those described for local and regional recurrence); bone marrow; skeletal; lungs and pleural; ascites and pleural effusions; liver and other viscera; and central nervous system (CNS). Time to distant recurrence is defined as the interval between the date of randomization and the date of the first occurrence of a distant recurrence.

  • Time to Central Nervous System (CNS) Recurrence [ Time Frame: 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]) ] [ Designated as safety issue: No ]
    Time to CNS recurrence is defined as the interval between the date of randomization and the date of the occurrence of a CNS recurrence if noted as part of the participant's first recurrence. Time to CNS recurrence was not calculated; data are presented as the number of participants with CNS recurrence in the subsequent outcome measure table.

  • Number of Participants With CNS Recurrence [ Time Frame: 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]) ] [ Designated as safety issue: No ]
    The number of participants experiencing a CNS recurrence was summarized.

  • Modified Disease-free Survival (MDFS) [ Time Frame: 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) ] [ Designated as safety issue: No ]
    Modified disease recurrence=interval between the date of randomization and the date of the first occurrence of an objective disease recurrence, contralateral breast cancer, or death from any cause. The date of the event=the earliest date of the occurrence of any of the following events: local recurrence following mastectomy; local recurrence in ipsilateral breast following lumpectomy; regional recurrence; distant recurrence; contralateral breast cancer, including DCIS; death from any cause without a prior event. MDFS was not calculated; data are presented as the number of participants with any recurrence of the initial disease, contralateral breast cancer, or death (disease-free survival) in the subsequent outcome measure table.

  • Number of Participants With Any Recurrence of the Initial Disease, Contralateral Breast Cancer, or Death (Disease-free Survival [DFS]) [ Time Frame: 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) ] [ Designated as safety issue: No ]
    DFS=interval between the date of randomization and the date of the first occurrence of an objective disease recurrence, a second primary cancer, or death from any cause. The date of the event is the earliest date of the occurrence of any of the following: local recurrence (LR) following mastectomy; LR in ipsilateral breast following lumpectomy; regional recurrence; distant recurrence and contralateral breast cancer, including ductal carcinoma in situ; or death from any cause without a prior event. Participants who started additional anti-cancer adjuvant therapy prior to the recurrence of their disease were to be censored. Participants who did not withdraw from the study and did not experience a specified event or death were to be censored (follow-up ongoing) at the last visit date available at which progression was assessed.

  • Change From Baseline in Short Form-36 Version 2 (SF-36 v2) Scores for the Physical Component Summary (PCS) [ Time Frame: 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) ] [ Designated as safety issue: No ]
    The SF-36 v2 is a self-administered, health-related quality of life (QoL) metric. It is a 36-item questionnaire designed to measure 8 domains of functional health status and well-being: physical functioning, role-physical, bodily pain, general health perceptions, vitality, social functioning, role-emotional, and mental health. Each domain is scored from 0 (poorer health) to 100 (better health).The PCS score is a summary score representing overall physical health, which is derived from the 8 domain scores. As with each domain score, the PCS score ranges from 0 to 100; higher scores represent better health. Change from Baseline was calculated as the post-Baseline score minus the Baseline score. Missing post-Baseline data were imputed using the last observation carried forward (LOCF) method. The scores were analyzed using an analysis of covariance (ANCOVA) model, adjusting for Baseline sub-scale score, treatment, and country. Positive changes from Baseline indicate improvement.

  • Change From Baseline in SF-36 v2 Scores for the Mental Component Summary (MCS) [ Time Frame: 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) ] [ Designated as safety issue: No ]
    The SF-36 v2 is a self-administered, health-related quality of life (QoL) metric. It is a 36-item questionnaire designed to measure 8 domains of functional health status and well-being: physical functioning, role-physical, bodily pain, general health perceptions, vitality, social functioning, role-emotional, and mental health. Each domain is scored from 0 (poorer health) to 100 (better health).The MCS score is a summary score representing overall mental health, which is derived from the 8 domain scores. As with each domain score, the MCS score ranges from 0 to 100; higher scores represent better health. Change from Baseline was calculated as the post-Baseline score minus the Baseline score. Missing post-Baseline data were imputed using the LOCF method. The scores were analyzed using an ANCOVA model adjusting for Baseline sub-scale score, treatment, and country. Positive changes from Baseline indicate improvement.

  • 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) [ Time Frame: 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) ] [ Designated as safety issue: No ]
    The SF-36 v2 is a self-administered, health-related quality of life (QoL) metric. It is a 36-item questionnaire designed to measure 8 domains of functional health status and well-being: physical functioning (PF), role-physical (RP), bodily pain (BP), general health (GH) perceptions, vitality (VT), social functioning (SF), role-emotional (RE), and mental health (MH). Each domain is scored from 0 (poorer health) to 100 (better health); higher scores represent better health. Change from Baseline was calculated as the post-Baseline score minus the Baseline score. Missing post-Baseline data were imputed using the LOCF method. The scores were analyzed using an ANCOVA model, adjusting for Baseline sub-scale score, treatment, and country. Positive changes from Baseline indicate improvement.

  • Number of Participants With Hematology Values Outside the Reference Range for the Indicated Parameters [ Time Frame: At Baseline and every 3 months thereafter up to Month 12/Early Withdrawal Visit ] [ Designated as safety issue: No ]
    The hematology parameters assessed were: basophils (Bs) in giga (10^9) per liter (GI/L) and in percentage (%), eosinophils (Eo) in GI/L and %, hematocrit, hemoglobin, lymphocytes (Lmph) in GI/L and %, monocytes (Mono) in GI/L and %, platelet count, Red Blood Cell (RBC) count, total neutrophil count (TNC) in GI/L and %, and White Blood Cell (WBC) count. The Baseline (BL) value is the last available pre-treatment result recorded. "Any post-Baseline value" was based on results recorded at any scheduled or unscheduled post-Baseline visits. The prevalence of values lying outside the reference (ref.) range (high or low) is presented for BL and "any post-Baseline" (APBL) visit. Two participants were randomized to placebo but received lapatinib; therefore, they are included in the lapatinib treatment arm. Data for the primary analysis (conducted in 2011) are reported.

  • Number of Participants With Clinical Chemistry Values Outside the Reference Range for the Indicated Parameters [ Time Frame: At Baseline and every 6 weeks thereafter up to Month 12/Early Withdrawal Visit ] [ Designated as safety issue: No ]
    The clinical chemistry parameters assessed were: alanine amino transferase (ALT), albumin, alkaline phosphatase (ALP), aspartate amino transferase (AST), bicarbonate, blood urea nitrogen (BUN), bone alkaline phosphatase (Bone ALP), calcium, chloride, creatinine, creatinine clearance (Cr. Clearance), creatinine clearance estimated (Cr. Clrnc. est.), glucose, potassium, sodium, total bilirubin (Total Bln), total protein, urea, and uric acid. The Baseline (BL) value is the last available pre-treatment result recorded. "Any post-Baseline" value was based on results recorded at scheduled or unscheduled post-Baseline visits. The prevalence of values lying outside the reference (ref.) range (high or low) was presented for BL and "any post-Baseline" (APBL) visit. Two participants were randomized to placebo but received lapatinib; therefore, they are included in the lapatinib treatment arm.

  • Number of Participants With Non-laboratory Toxicities of the Indicated Toxicity Grades [ Time Frame: From the first dose of study treatment up to 12 months ] [ Designated as safety issue: No ]
    Non-laboratory toxicities are defined as adverse events (AEs). The number of partcipants with any treatment-emergent AE of the indicated toxicity grade are summarized. Toxicity grading was according to the National Cancer Institute Common Terminology Criteria for Adverse Events Version 3.0 as follows: Grade 1=mild; Grade 2=moderate; Grade 3=severe; Grade 4=life threatening; Grade 5=death. The events that were not given a toxicity grade are categorized as "Not Applicable."

  • Number of Participants Experiencing Primary or Secondary Cardiac Events [ Time Frame: From the date of randomization up to 12 months ] [ Designated as safety issue: No ]
    A cardiac event is classified as a primary cardiac endpoint (PCE) or a secondary cardiac endpoint (SCE). PCE is defined as: cardiac death (cardiac death due to heart failure, myocardial infarction, or arrhythmia;or probable cardiac death defined as sudden, unexpected death within 24 hours of a definite or probable cardiac event); severe symptomatic congestive heart failure (CHF) (as per New York Heart Association [NYHA] Class III or IV and an absolute decrease in left ventricular ejection fraction [LVEF] of more than 10 percentage points from Baseline and to a left ventricular ejection fraction [LVEF] value below 50%). SCE is defined as asymptomatic or mildly symptomatic cardiac events (NYHA Class I or II) and a significant decrease in LVEF, defined as an absolute decrease in LVEF of more than 10 percentage points from Baseline and to an LVEF value below 50%.

  • Number of Participants With the Indicated Electrocardiogram (ECG) Findings [ Time Frame: Screening and Month 12/Early Withdrawal Visit ] [ Designated as safety issue: No ]
    12-lead ECG measurements were taken at Screening and at study conclusion/withdrawal. The number of participants with normal, abnormal clinically significant (CS), and abnormal not clinically significant (NCS) ECG findings, as classified by the investigator, were summarized. Participants with missing values were categorized as missing. Data for the primary analysis (conducted in 2011) are reported.


Enrollment: 3166
Study Start Date: August 2006
Study Completion Date: July 2013
Primary Completion Date: September 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Placebo
6 tablets daily for 12 months
Other: placebo
6 tablets daily for 12 months
Experimental: Lapatinib
Lapatinib 1500 mg (6 tablets) daily for 12 months
Drug: lapatinib
Lapatinib 1500 mg (6 tablets) daily for 12 months

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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;
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00374322

  Hide Study Locations
Locations
United States, Alabama
GSK Investigational Site
Tuscaloosa, Alabama, United States, 35406
United States, Arizona
GSK Investigational Site
Phoenix, Arizona, United States, 85012
GSK Investigational Site
Sedona, Arizona, United States, 86336
GSK Investigational Site
Tucson, Arizona, United States, 85715
United States, Arkansas
GSK Investigational Site
Fayetteville, Arkansas, United States, 72703
GSK Investigational Site
Jonesboro, Arkansas, United States, 72401
GSK Investigational Site
Little Rock, Arkansas, United States, 72205
United States, California
GSK Investigational Site
Anaheim, California, United States, 92801
GSK Investigational Site
Bakersfield, California, United States, 93309
GSK Investigational Site
Gilroy, California, United States, 95020
GSK Investigational Site
La Jolla, California, United States, 92037
GSK Investigational Site
La Verne, California, United States, 91750
GSK Investigational Site
Palm Springs, California, United States, 92262
GSK Investigational Site
Rancho Mirage, California, United States, 92270
United States, Colorado
GSK Investigational Site
Denver, Colorado, United States, 80220
United States, Connecticut
GSK Investigational Site
Fairfield, Connecticut, United States, 06824
GSK Investigational Site
Norwalk, Connecticut, United States, 06856
GSK Investigational Site
Torrington, Connecticut, United States, 06790
United States, District of Columbia
GSK Investigational Site
Washington, District of Columbia, United States, 20010
GSK Investigational Site
Washington, District of Columbia, United States, 20007
United States, Florida
GSK Investigational Site
Boca Raton, Florida, United States, 33428
GSK Investigational Site
Boynton Beach, Florida, United States, 33437
GSK Investigational Site
Gainesville, Florida, United States, 32605
GSK Investigational Site
New Port Richey, Florida, United States, 34655
GSK Investigational Site
Ocala, Florida, United States, 34474
GSK Investigational Site
Orlando, Florida, United States, 32806
GSK Investigational Site
Plantation, Florida, United States, 33324
GSK Investigational Site
Port St. Lucie, Florida, United States, 34952
United States, Georgia
GSK Investigational Site
Augusta, Georgia, United States, 30901
GSK Investigational Site
Marietta, Georgia, United States, 30060
United States, Illinois
GSK Investigational Site
Chicago, Illinois, United States, 60611-2906
GSK Investigational Site
Chicago, Illinois, United States, 60611
GSK Investigational Site
Joliet, Illinois, United States, 60435
GSK Investigational Site
Park Ridge, Illinois, United States, 60068
United States, Indiana
GSK Investigational Site
Indianapolis, Indiana, United States, 46219
United States, Iowa
GSK Investigational Site
Ames, Iowa, United States, 50010
GSK Investigational Site
Sioux City, Iowa, United States, 51101-1733
United States, Kansas
GSK Investigational Site
Wichita, Kansas, United States, 67214
United States, Kentucky
GSK Investigational Site
Louisville, Kentucky, United States, 40245
United States, Louisiana
GSK Investigational Site
Marrero, Louisiana, United States, 70072
United States, Maine
GSK Investigational Site
Scarborough, Maine, United States, 4074
United States, Maryland
GSK Investigational Site
Bethesda, Maryland, United States, 20817
United States, Massachusetts
GSK Investigational Site
Boston, Massachusetts, United States, 02114
GSK Investigational Site
Danvers, Massachusetts, United States, 01923
GSK Investigational Site
Newton, Massachusetts, United States, 02462
United States, Michigan
GSK Investigational Site
Kalamazoo, Michigan, United States, 49048
United States, Minnesota
GSK Investigational Site
Duluth, Minnesota, United States, 55805
GSK Investigational Site
Edina, Minnesota, United States, 55435
GSK Investigational Site
Minneapolis, Minnesota, United States, 55404
GSK Investigational Site
Robbinsdale, Minnesota, United States, 55422
United States, Missouri
GSK Investigational Site
Columbia, Missouri, United States, 65201
GSK Investigational Site
Kansas City, Missouri, United States, 64118
GSK Investigational Site
Saint Louis, Missouri, United States, 63109
GSK Investigational Site
St. Joseph, Missouri, United States, 64507
GSK Investigational Site
St. Louis, Missouri, United States, 63141
United States, New Hampshire
GSK Investigational Site
Hooksett, New Hampshire, United States, 03106
United States, New Jersey
GSK Investigational Site
Cherry Hill, New Jersey, United States, 08003
GSK Investigational Site
Morristown, New Jersey, United States, 07962
GSK Investigational Site
Paramus, New Jersey, United States, 07652
GSK Investigational Site
Sparta, New Jersey, United States, 07871
United States, New York
GSK Investigational Site
Albany, New York, United States, 12206
GSK Investigational Site
East Setauket, New York, United States, 11733
GSK Investigational Site
Mount Kisco, New York, United States, 10590
GSK Investigational Site
New York, New York, United States, 10016
GSK Investigational Site
New York, New York, United States, 10003
GSK Investigational Site
Rochester, New York, United States, 14623
United States, North Carolina
GSK Investigational Site
Charleston, North Carolina, United States, 29406
GSK Investigational Site
Gastonia, North Carolina, United States, 28054
GSK Investigational Site
Greensboro, North Carolina, United States, 27403
GSK Investigational Site
Hickory, North Carolina, United States, 28602
United States, Ohio
GSK Investigational Site
Cleveland, Ohio, United States, 44106
GSK Investigational Site
Cleveland, Ohio, United States, 44195
GSK Investigational Site
Columbus, Ohio, United States, 43215
GSK Investigational Site
Middletown, Ohio, United States, 45042
United States, Pennsylvania
GSK Investigational Site
Drexel Hill, Pennsylvania, United States, 19026
GSK Investigational Site
Philadelphia, Pennsylvania, United States, 19107
United States, South Carolina
GSK Investigational Site
Charleston, South Carolina, United States, 29414
United States, Tennessee
GSK Investigational Site
Chattanooga, Tennessee, United States, 37403
GSK Investigational Site
Germantown, Tennessee, United States, 38138
GSK Investigational Site
Memphis, Tennessee, United States, 38120
United States, Texas
GSK Investigational Site
Austin, Texas, United States, 78759
GSK Investigational Site
Austin, Texas, United States, 78705
GSK Investigational Site
Bedford, Texas, United States, 76022
GSK Investigational Site
Dallas, Texas, United States, 75231
GSK Investigational Site
Dallas, Texas, United States, 75246
GSK Investigational Site
Dallas, Texas, United States, 75230
GSK Investigational Site
Duncanville, Texas, United States, 75137
GSK Investigational Site
El Paso, Texas, United States, 79902
GSK Investigational Site
Fort Worth, Texas, United States, 76104
GSK Investigational Site
Houston, Texas, United States, 77030
GSK Investigational Site
Houston, Texas, United States, 77024
GSK Investigational Site
Round Rock, Texas, United States, 78681
GSK Investigational Site
San Antonio, Texas, United States, 78229
GSK Investigational Site
Tyler, Texas, United States, 75702
GSK Investigational Site
Waco, Texas, United States, 76712
United States, Utah
GSK Investigational Site
Ogden, Utah, United States, 84403
United States, Virginia
GSK Investigational Site
Chesapeake, Virginia, United States, 23320
GSK Investigational Site
Fairfax, Virginia, United States, 22031
GSK Investigational Site
Richland, Virginia, United States, 24641
United States, Washington
GSK Investigational Site
Kirkland, Washington, United States
GSK Investigational Site
Seattle, Washington, United States, 98104
GSK Investigational Site
Vancouver, Washington, United States, 98684
GSK Investigational Site
Yakima, Washington, United States, 98902
Argentina
GSK Investigational Site
Capital Federal, Buenos Aires, Argentina, C1405CUB
GSK Investigational Site
Ciudad Autonoma de Buenos Aires, Buenos Aires, Argentina, C1405BCH
GSK Investigational Site
Ciudad Autonoma de Buenos Aires, Buenos Aires, Argentina, C1185AAT
GSK Investigational Site
Córdoba, Córdova, Argentina, X5006HBF
GSK Investigational Site
Neuquen, Neuquén, Argentina, Q8300HDH
GSK Investigational Site
Rosario, Santa Fe, Argentina, S2000KZE
GSK Investigational Site
Ciudad Autónoma de Buenos Aires, Argentina, C1417DTN
GSK Investigational Site
Quilmes, Argentina, 1878
GSK Investigational Site
San Miguel de Tucumán, Argentina, T4000IAK
GSK Investigational Site
Santa Fe, Argentina, 3000
Australia, New South Wales
GSK Investigational Site
Campbelltown, New South Wales, Australia, 2560
GSK Investigational Site
Darlinghurst, New South Wales, Australia, 2010
GSK Investigational Site
Kogarah, New South Wales, Australia, 2217
GSK Investigational Site
Liverpool, New South Wales, Australia, 2170
GSK Investigational Site
North Sydney, New South Wales, Australia, 2060
Australia, Queensland
GSK Investigational Site
Douglas, Queensland, Australia, 4814
GSK Investigational Site
Herston, Queensland, Australia, 4029
GSK Investigational Site
Redcliffe, Queensland, Australia, 4020
GSK Investigational Site
South Brisbane, Queensland, Australia, 4101
Australia, South Australia
GSK Investigational Site
Bedford Park, South Australia, Australia, 5042
GSK Investigational Site
Elizabeth Vale, South Australia, Australia, 5112
GSK Investigational Site
Woodville, South Australia, Australia, 5011
Australia, Victoria
GSK Investigational Site
Box Hill, Victoria, Australia, 3128
GSK Investigational Site
East Melbourne, Victoria, Australia, 3002
GSK Investigational Site
Fitzroy, Victoria, Australia, 3065
GSK Investigational Site
Footscray, Victoria, Australia, 3011
GSK Investigational Site
Heidelberg, Victoria, Australia, 3084
GSK Investigational Site
Parkville, Victoria, Australia, 3050
GSK Investigational Site
Ringwood East, Victoria, Australia, 3135
GSK Investigational Site
Wodonga, Victoria, Australia, 3690
Australia, Western Australia
GSK Investigational Site
Nedlands, Western Australia, Australia, 6009
GSK Investigational Site
Perth, Western Australia, Australia, 6000
Belgium
GSK Investigational Site
Bruxelles, Belgium, 1000
Brazil
GSK Investigational Site
Belo Horizonte, Minas Gerais, Brazil, 30.140-001
GSK Investigational Site
Porto Alegre, Rio Grande Do Sul, Brazil, 90020-090
GSK Investigational Site
Porto Alegre, Rio Grande Do Sul, Brazil, 90610 000
GSK Investigational Site
Santo Andre, São Paulo, Brazil, 09060-670
GSK Investigational Site
Rio de Janeiro, Brazil, 21941-913
GSK Investigational Site
São Paulo, Brazil, 03102-002
Canada, Newfoundland and Labrador
GSK Investigational Site
St. John's, Newfoundland and Labrador, Canada, A1B 3V6
Canada, Nova Scotia
GSK Investigational Site
Halifax, Nova Scotia, Canada, B3H 1V7
Canada, Ontario
GSK Investigational Site
Barrie, Ontario, Canada, L4M 6M2
GSK Investigational Site
Brampton, Ontario, Canada, L6W 2Z8
GSK Investigational Site
Kingston, Ontario, Canada, K7L 5P9
GSK Investigational Site
London, Ontario, Canada, N6A 4L6
GSK Investigational Site
Mississauga, Ontario, Canada, L5M 2N1
GSK Investigational Site
Oshawa, Ontario, Canada, L1G 2B9
GSK Investigational Site
Ottawa, Ontario, Canada, K1H 8L6
GSK Investigational Site
Toronto, Ontario, Canada, M4N 3M5
GSK Investigational Site
Toronto, Ontario, Canada, M4C 3E7
GSK Investigational Site
Toronto, Ontario, Canada, M5B 1W8
GSK Investigational Site
Toronto, Ontario, Canada, M6R 1B5
Canada, Quebec
GSK Investigational Site
Greenfield Park, Quebec, Canada, J4V 2H1
GSK Investigational Site
Montreal, Quebec, Canada, H3T 1E2
Canada, Saskatchewan
GSK Investigational Site
Saskatoon, Saskatchewan, Canada, S7N 4H4
Canada
GSK Investigational Site
Quebec, Canada, G1S 4L8
Chile
GSK Investigational Site
Santiago, Región Metro De Santiago, Chile, 7591046
GSK Investigational Site
Santiago, Región Metro De Santiago, Chile, 750 1088
GSK Investigational Site
Santiago, Región Metro De Santiago, Chile, 7500921
GSK Investigational Site
Viña del Mar, Valparaíso, Chile, 254-0364
China, Guangdong
GSK Investigational Site
Guangzhou, Guangdong, China, 510060
China, Hubei
GSK Investigational Site
Wuhan, Hubei, China, 430030
China, Shandong
GSK Investigational Site
Jinan, Shandong, China, 250117
China
GSK Investigational Site
Beijing, China, 100071
GSK Investigational Site
Beijing, China, 100021
GSK Investigational Site
Beijing, China, 100036
GSK Investigational Site
Shanghai, China, 200032
GSK Investigational Site
Tianjin, China, 300060
Croatia
GSK Investigational Site
Osijek, Croatia, 31000
GSK Investigational Site
Pula, Croatia, 52 100
GSK Investigational Site
Rijeka, Croatia, 51000
GSK Investigational Site
Split, Croatia, 21000
GSK Investigational Site
Zagreb, Croatia, 10 000
Czech Republic
GSK Investigational Site
Brno, Czech Republic, 656 53
GSK Investigational Site
Prague 2, Czech Republic, 121 00
GSK Investigational Site
Praha 8, Czech Republic, 180 00
Denmark
GSK Investigational Site
Aalborg, Denmark, 9100
GSK Investigational Site
Copenhagen, Denmark, DK-2100
GSK Investigational Site
Esbjerg, Denmark, 6700
GSK Investigational Site
Herlev, Denmark, DK-2730
GSK Investigational Site
Naestved, Denmark, 4700
GSK Investigational Site
Odense, Denmark, 5000
GSK Investigational Site
Roskilde, Denmark, 4000
GSK Investigational Site
Vejle, Denmark, 7100
France
GSK Investigational Site
Angers, France, 49933
GSK Investigational Site
Besançon, France, 25030
GSK Investigational Site
Bordeaux, France, 33000
GSK Investigational Site
Caen Cedex 05, France, 14076
GSK Investigational Site
Clermont Ferrand, France, 63000
GSK Investigational Site
Colmar Cedex, France, 68024
GSK Investigational Site
Dijon Cedex, France, 21079
GSK Investigational Site
Lille, France, 59000
GSK Investigational Site
Lille cedex, France, 59020
GSK Investigational Site
Lyon, France, 69008
GSK Investigational Site
Lyon Cedex 08, France, 69373
GSK Investigational Site
Marseille Cedex 09, France, 13273
GSK Investigational Site
Montbeliard, France, 25200
GSK Investigational Site
Montpellier Cedex 5, France, 34298
GSK Investigational Site
Nantes cedex, France, 44202
GSK Investigational Site
Nice Cedex 2, France, 06189
GSK Investigational Site
Paris Cedex 15, France, 75908
GSK Investigational Site
Reims, France, 51100
GSK Investigational Site
Rennes, France, 35042
GSK Investigational Site
Saint Grégoire, France, 35760
GSK Investigational Site
Saint-Cloud, France, 92210
GSK Investigational Site
Saint-Herblain, France, 44805
GSK Investigational Site
Strasbourg, France, 67000
GSK Investigational Site
Toulouse Cedex 3, France, 31076
GSK Investigational Site
Toulouse Cedex 9, France, 31059
GSK Investigational Site
Tourcoing, France, 59200
GSK Investigational Site
Vandoeuvre-Les-Nancy, France, 54511
GSK Investigational Site
Villejuif, France, 94804
GSK Investigational Site
Villejuif Cedex, France, 94805
Germany
GSK Investigational Site
Freiburg, Baden-Wuerttemberg, Germany, 79106
GSK Investigational Site
Heidelberg, Baden-Wuerttemberg, Germany, 69115
GSK Investigational Site
Konstanz, Baden-Wuerttemberg, Germany, 78464
GSK Investigational Site
Mannheim, Baden-Wuerttemberg, Germany, 68161
GSK Investigational Site
Mayen, Baden-Wuerttemberg, Germany, 56727
GSK Investigational Site
Mutlangen, Baden-Wuerttemberg, Germany, 73557
GSK Investigational Site
Rheinfelden, Baden-Wuerttemberg, Germany, 79618
GSK Investigational Site
Schwetzingen, Baden-Wuerttemberg, Germany, 68723
GSK Investigational Site
Singen, Baden-Wuerttemberg, Germany, 78224
GSK Investigational Site
Stuttgart, Baden-Wuerttemberg, Germany, 70190
GSK Investigational Site
Stuttgart, Baden-Wuerttemberg, Germany, 70376
GSK Investigational Site
Tuebingen, Baden-Wuerttemberg, Germany, 72076
GSK Investigational Site
Ulm, Baden-Wuerttemberg, Germany, 89075
GSK Investigational Site
Amberg, Bayern, Germany, 92224
GSK Investigational Site
Aschaffenburg, Bayern, Germany, 63739
GSK Investigational Site
Bayreuth, Bayern, Germany, 95445
GSK Investigational Site
Deggendorf, Bayern, Germany, 94469
GSK Investigational Site
Ebersberg, Bayern, Germany, 85560
GSK Investigational Site
Eggenfelden, Bayern, Germany, 84307
GSK Investigational Site
Erlangen, Bayern, Germany, 91054
GSK Investigational Site
Fuerth, Bayern, Germany, 90766
GSK Investigational Site
Kempten, Bayern, Germany, 87439
GSK Investigational Site
Krumbach, Bayern, Germany, 86381
GSK Investigational Site
Marktredwitz, Bayern, Germany, 95615
GSK Investigational Site
Memmingen, Bayern, Germany, 87700
GSK Investigational Site
Muenchen, Bayern, Germany, 81377
GSK Investigational Site
Muenchen, Bayern, Germany, 80331
GSK Investigational Site
Muenchen, Bayern, Germany, 80637
GSK Investigational Site
Muenchen, Bayern, Germany, 80335
GSK Investigational Site
Muenchen, Bayern, Germany, 80337
GSK Investigational Site
Rehling, Bayern, Germany, 86508
GSK Investigational Site
Rosenheim, Bayern, Germany, 83022
GSK Investigational Site
Roth, Bayern, Germany, 91154
GSK Investigational Site
Schwandorf, Bayern, Germany, 92421
GSK Investigational Site
Weiden, Bayern, Germany, 92637
GSK Investigational Site
Cottbus, Brandenburg, Germany, 03046
GSK Investigational Site
Fuerstenwalde, Brandenburg, Germany, 15517
GSK Investigational Site
Frankfurt, Hessen, Germany, 60596
GSK Investigational Site
Frankfurt, Hessen, Germany, 60389
GSK Investigational Site
Frankfurt, Hessen, Germany, 65929
GSK Investigational Site
Frankfurt am Main, Hessen, Germany, 60590
GSK Investigational Site
Kassel, Hessen, Germany, 34117
GSK Investigational Site
Kassel, Hessen, Germany, 34131
GSK Investigational Site
Wiesbaden, Hessen, Germany, 65191
GSK Investigational Site
Guestrow, Mecklenburg-Vorpommern, Germany, 18273
GSK Investigational Site
Goslar, Niedersachsen, Germany, 38642
GSK Investigational Site
Hannover, Niedersachsen, Germany, 30625
GSK Investigational Site
Hildesheim, Niedersachsen, Germany, 31134
GSK Investigational Site
Salzgitter, Niedersachsen, Germany, 38226
GSK Investigational Site
Bochum, Nordrhein-Westfalen, Germany, 44799
GSK Investigational Site
Bonn, Nordrhein-Westfalen, Germany, 53113
GSK Investigational Site
Duesseldorf, Nordrhein-Westfalen, Germany, 40235
GSK Investigational Site
Duisburg, Nordrhein-Westfalen, Germany, 47051
GSK Investigational Site
Duisburg, Nordrhein-Westfalen, Germany, 47166
GSK Investigational Site
Essen, Nordrhein-Westfalen, Germany, 45130
GSK Investigational Site
Herne, Nordrhein-Westfalen, Germany, 44623
GSK Investigational Site
Hilden, Nordrhein-Westfalen, Germany, 40724
GSK Investigational Site
Koeln, Nordrhein-Westfalen, Germany, 50677
GSK Investigational Site
Koeln, Nordrhein-Westfalen, Germany, 50937
GSK Investigational Site
Muelheim, Nordrhein-Westfalen, Germany, 45473
GSK Investigational Site
Porta Westfalica, Nordrhein-Westfalen, Germany, 32457
GSK Investigational Site
Recklinghausen, Nordrhein-Westfalen, Germany, 45657
GSK Investigational Site
Troisdorf, Nordrhein-Westfalen, Germany, 53840
GSK Investigational Site
Velbert, Nordrhein-Westfalen, Germany, 42551
GSK Investigational Site
Witten, Nordrhein-Westfalen, Germany, 58452
GSK Investigational Site
Koblenz, Rheinland-Pfalz, Germany, 56068
GSK Investigational Site
Mainz, Rheinland-Pfalz, Germany, 55131
GSK Investigational Site
Homburg/Saar, Saarland, Germany, 66421
GSK Investigational Site
Neunkirchen, Saarland, Germany, 66538
GSK Investigational Site
Saarbruecken, Saarland, Germany, 66113
GSK Investigational Site
Blankenburg, Sachsen-Anhalt, Germany, 38889
GSK Investigational Site
Halle, Sachsen-Anhalt, Germany, 06120
GSK Investigational Site
Magdeburg, Sachsen-Anhalt, Germany, 39108
GSK Investigational Site
Magdeburg, Sachsen-Anhalt, Germany, 39104
GSK Investigational Site
Stendal, Sachsen-Anhalt, Germany, 39576
GSK Investigational Site
Chemnitz, Sachsen, Germany, 09116
GSK Investigational Site
Dresden, Sachsen, Germany, 01307
GSK Investigational Site
Kauschwitz, Sachsen, Germany, 08525
GSK Investigational Site
Neustadt, Sachsen, Germany, 01844
GSK Investigational Site
Spremberg, Sachsen, Germany, 03130
GSK Investigational Site
Zittau, Sachsen, Germany, 02763
GSK Investigational Site
Zwickau, Sachsen, Germany, 08060
GSK Investigational Site
Kiel, Schleswig-Holstein, Germany, 24103
GSK Investigational Site
Luebeck, Schleswig-Holstein, Germany, 23538
GSK Investigational Site
Eisenach, Thueringen, Germany, 99817
GSK Investigational Site
Jena, Thueringen, Germany, 07743
GSK Investigational Site
Berlin, Germany, 13125
GSK Investigational Site
Berlin, Germany, 12683
GSK Investigational Site
Berlin, Germany, 14169
GSK Investigational Site
Berlin, Germany, 13156
GSK Investigational Site
Berlin, Germany, 14197
GSK Investigational Site
Berlin, Germany, 10367
GSK Investigational Site
Berlin, Germany, 10117
GSK Investigational Site
Bremen, Germany, 28177
GSK Investigational Site
Bremen, Germany, 28209
GSK Investigational Site
Hamburg, Germany, 22457
GSK Investigational Site
Hamburg, Germany, 20246
GSK Investigational Site
Hamburg, Germany, 22081
Greece
GSK Investigational Site
Athens, Greece, 185 37
GSK Investigational Site
Athens, Greece, 115 27
GSK Investigational Site
Athens, Greece, 11527
GSK Investigational Site
Chania, Greece, 73100
GSK Investigational Site
Heraklion, Crete, Greece, 71110
Hong Kong
GSK Investigational Site
Hong Kong, Hong Kong
GSK Investigational Site
Shatin, Hong Kong
GSK Investigational Site
Wanchai, Hong Kong
Hungary
GSK Investigational Site
Budapest, Hungary
GSK Investigational Site
Budapest, Hungary, 1076
GSK Investigational Site
Győr, Hungary, 9023
GSK Investigational Site
Kaposvár, Hungary, 7400
GSK Investigational Site
Kistarcsa, Hungary, 2143
GSK Investigational Site
Pécs, Hungary, 7624
GSK Investigational Site
Szeged, Hungary, 6720
India
GSK Investigational Site
Chennai, India, 600035
GSK Investigational Site
Hyderabad, India, 500082
GSK Investigational Site
Jaipur, India, 302013
GSK Investigational Site
Mumbai, India, 400012
GSK Investigational Site
New Delhi, India
GSK Investigational Site
Pune, India, 411001
Israel
GSK Investigational Site
Ashkelon, Israel, 78278
GSK Investigational Site
Haifa, Israel, 34362
GSK Investigational Site
Jerusalem, Israel, 91120
GSK Investigational Site
Kfar Saba, Israel, 44281
GSK Investigational Site
Ramat Gan, Israel, 52621
GSK Investigational Site
Rehovot, Israel, 76100
GSK Investigational Site
Tel Aviv, Israel, 64239
Italy
GSK Investigational Site
Avellino, Campania, Italy, 83100
GSK Investigational Site
Piacenza, Emilia-Romagna, Italy, 29100
GSK Investigational Site
Genova, Liguria, Italy, 16132
GSK Investigational Site
Sassari, Sardegna, Italy, 07100
GSK Investigational Site
Perugia, Umbria, Italy, 06132
GSK Investigational Site
Negrar (Verona), Veneto, Italy, 37024
Korea, Republic of
GSK Investigational Site
Goyang-si, Gyeonggi-do, Korea, Republic of, 410-769
GSK Investigational Site
Seoul, Korea, Republic of, 135-710
GSK Investigational Site
Seoul, Korea, Republic of, 110-744
GSK Investigational Site
songpa-gu, Seoul, Korea, Republic of, 138-736
Latvia
GSK Investigational Site
Liepaja, Latvia, LV3401
GSK Investigational Site
Riga, Latvia, LV 1002
GSK Investigational Site
Riga, Latvia, LV 1079
Lithuania
GSK Investigational Site
Kaunas, Lithuania, LT-50009
GSK Investigational Site
Klaipeda, Lithuania, LT-92228
GSK Investigational Site
Vilnius, Lithuania, LT-08660
Mexico
GSK Investigational Site
Mérida, Yucatán, Mexico, 97500
GSK Investigational Site
Chihuahua, Mexico, 31000
GSK Investigational Site
DF., Mexico, 01120
GSK Investigational Site
Mexico City, Mexico, CP 14080
GSK Investigational Site
México D.F., Mexico, 11000
New Zealand
GSK Investigational Site
Auckland, New Zealand, 1023
GSK Investigational Site
Christchurch, New Zealand, 8001
GSK Investigational Site
Hamilton, New Zealand, 2001
Peru
GSK Investigational Site
Lima, Peru, Lima 34
GSK Investigational Site
Lima, Peru, Lima 13
GSK Investigational Site
Lima, Peru, Lima 11
Philippines
GSK Investigational Site
Baguio City, Benguet, Philippines, 2600
GSK Investigational Site
Cebu, Philippines, 6000
GSK Investigational Site
Pasig City, Philippines, 1600
GSK Investigational Site
Quezon City, Philippines, 1101
Poland
GSK Investigational Site
Bydgoszcz, Poland, 85-792
GSK Investigational Site
Krakow, Poland, 31-115
GSK Investigational Site
Olsztyn, Poland, 10-226
GSK Investigational Site
Olsztyn, Poland, 10-228
GSK Investigational Site
Torun, Poland, 87-100
GSK Investigational Site
Warszawa, Poland, 00-909
Russian Federation
GSK Investigational Site
Moscow, Russian Federation, 115 478
GSK Investigational Site
Moscow, Russian Federation, 129301
GSK Investigational Site
Moscow, Russian Federation, 117997
GSK Investigational Site
Ryazan, Russian Federation, 390011
GSK Investigational Site
St. Petersburg, Russian Federation, 197022
GSK Investigational Site
St. Petersburg, Russian Federation, 197758
GSK Investigational Site
Yaroslavl, Russian Federation, 150054
Slovakia
GSK Investigational Site
Banska Bystrica, Slovakia, 975 17
GSK Investigational Site
Bardejov, Slovakia, 085 01
GSK Investigational Site
Bratislava, Slovakia, 833 10
GSK Investigational Site
Nitra, Slovakia, 950 01
South Africa
GSK Investigational Site
Tygerberg, Western Province, South Africa, 7505
GSK Investigational Site
Athlone Park, Amanzimtoti, South Africa, 4126
GSK Investigational Site
Groenkloof, South Africa, 0181
GSK Investigational Site
Kraaifontein, South Africa, 7570
GSK Investigational Site
Overport, South Africa, 4091
GSK Investigational Site
Parktown, South Africa, 2193
GSK Investigational Site
Port Elizabeth, South Africa, 6045
GSK Investigational Site
Sandton, South Africa, 2199
GSK Investigational Site
Saxonwold, Johannesburg, South Africa, 2196
Spain
GSK Investigational Site
Alcorcon, Spain, 28922
GSK Investigational Site
Barcelona, Spain, 08003
GSK Investigational Site
Barcelona, Spain, 08035
GSK Investigational Site
Cáceres, Spain, 10003
GSK Investigational Site
Girona, Spain, 17007
GSK Investigational Site
Jaén, Spain, 23007
GSK Investigational Site
Lerida, Spain, 25198
GSK Investigational Site
Llobregat, Spain, 08907
GSK Investigational Site
Madrid, Spain, 28034
GSK Investigational Site
Madrid, Spain, 28040
GSK Investigational Site
Mataró, Spain, 08304
GSK Investigational Site
Orense, Spain, 32005
GSK Investigational Site
Palma de Mallorca, Spain, 07010
GSK Investigational Site
Palma de Mallorca, Spain, 07198
GSK Investigational Site
Santa Cruz de Tenerife, Spain, 38320
GSK Investigational Site
Santander, Spain, 39008
GSK Investigational Site
Santiago de Compostela, Spain, 15706
GSK Investigational Site
Valencia, Spain, 46010
GSK Investigational Site
Zaragoza, Spain, 50009
Ukraine
GSK Investigational Site
Dnepropetrovsk, Ukraine, 49102
GSK Investigational Site
Kyiv, Ukraine, 03115
GSK Investigational Site
Lvov, Ukraine, 79031
GSK Investigational Site
Uzhgorod, Ukraine, 88017
United Kingdom
GSK Investigational Site
Chelmsford, Essex, United Kingdom, CM1 7ET
GSK Investigational Site
Manchester, Lancashire, United Kingdom, M20 4BX
GSK Investigational Site
Sutton, Surrey, United Kingdom, SM2 5PT
GSK Investigational Site
Bournemouth, United Kingdom, BH7 7DW
GSK Investigational Site
Edgbaston, Birmingham, United Kingdom, B15 2TH
GSK Investigational Site
Glasgow, United Kingdom, G12 OYN
GSK Investigational Site
Lindley, United Kingdom, HD3 3EA
GSK Investigational Site
London, United Kingdom, NW3 2QG
GSK Investigational Site
London, United Kingdom, SE1 9RT
GSK Investigational Site
London, United Kingdom, NW1 2PG
GSK Investigational Site
London, United Kingdom, SW3 6JJ
GSK Investigational Site
Maidstone, United Kingdom, ME16 9QQ
GSK Investigational Site
Manchester, United Kingdom, M23 9LT
GSK Investigational Site
Newcastle upon Tyne, United Kingdom, NE7 7DN
GSK Investigational Site
Nottingham, United Kingdom, NG5 1PB
GSK Investigational Site
Sheffield, United Kingdom, S10 2SJ
GSK Investigational Site
Shrewsbury, United Kingdom, SY3 8XQ
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

No publications provided by GlaxoSmithKline

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00374322     History of Changes
Other Study ID Numbers: EGF105485
Study First Received: September 7, 2006
Results First Received: July 17, 2014
Last Updated: August 14, 2014
Health Authority: Germany: Federal Institute for Drugs and Medical Devices
United States: Food and Drug Administration

Keywords provided by GlaxoSmithKline:
Breast Cancer
ErbB2-overexpressing
early-stage breast cancer
adjuvant

Additional relevant MeSH terms:
Breast Neoplasms
Breast Diseases
Neoplasms
Neoplasms by Site
Skin Diseases
Lapatinib
Antineoplastic Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Protein Kinase Inhibitors
Therapeutic Uses

ClinicalTrials.gov processed this record on October 29, 2014