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

NCT ID: NCT00374322

Last Updated: 2014-08-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 3166 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-08-31
• Study Completion Date: 2013-07-31

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.

Conditions

Neoplasms, Breast

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Placebo

6 tablets daily for 12 months

Group Type: PLACEBO_COMPARATOR

placebo

Intervention Type: OTHER

6 tablets daily for 12 months

Lapatinib

Lapatinib 1500 mg (6 tablets) daily for 12 months

Group Type: EXPERIMENTAL

lapatinib

Intervention Type: DRUG

Lapatinib 1500 mg (6 tablets) daily for 12 months

Interventions

lapatinib

Lapatinib 1500 mg (6 tablets) daily for 12 months

Intervention Type: DRUG

placebo

6 tablets daily for 12 months

Intervention Type: OTHER

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;

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

GlaxoSmithKline

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

GSK Clinical Trials

Role: STUDY_DIRECTOR

GlaxoSmithKline

Locations

GSK Investigational Site

Rheinfelden, Baden-Wurttemberg, Germany

GSK Investigational Site

Tuscaloosa, Alabama, United States

GSK Investigational Site

Phoenix, Arizona, United States

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Sedona, Arizona, United States

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Tucson, Arizona, United States

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Fayetteville, Arkansas, United States

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Jonesboro, Arkansas, United States

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Little Rock, Arkansas, United States

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Anaheim, California, United States

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Bakersfield, California, United States

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Gilroy, California, United States

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La Jolla, California, United States

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La Verne, California, United States

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Palm Springs, California, United States

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Rancho Mirage, California, United States

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Denver, Colorado, United States

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Fairfield, Connecticut, United States

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Norwalk, Connecticut, United States

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Torrington, Connecticut, United States

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Washington D.C., District of Columbia, United States

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Washington D.C., District of Columbia, United States

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Boca Raton, Florida, United States

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Boynton Beach, Florida, United States

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Gainesville, Florida, United States

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New Port Richey, Florida, United States

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Ocala, Florida, United States

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Orlando, Florida, United States

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Plantation, Florida, United States

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Port Saint Lucie, Florida, United States

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Augusta, Georgia, United States

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Marietta, Georgia, United States

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Chicago, Illinois, United States

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Chicago, Illinois, United States

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Joliet, Illinois, United States

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Park Ridge, Illinois, United States

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Indianapolis, Indiana, United States

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Ames, Iowa, United States

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Sioux City, Iowa, United States

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Wichita, Kansas, United States

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Louisville, Kentucky, United States

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Marrero, Louisiana, United States

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Scarborough, Maine, United States

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Bethesda, Maryland, United States

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Boston, Massachusetts, United States

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Danvers, Massachusetts, United States

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Newton, Massachusetts, United States

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Kalamazoo, Michigan, United States

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Duluth, Minnesota, United States

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Edina, Minnesota, United States

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Minneapolis, Minnesota, United States

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Robbinsdale, Minnesota, United States

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Columbia, Missouri, United States

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Kansas City, Missouri, United States

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Saint Joseph, Missouri, United States

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St Louis, Missouri, United States

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St Louis, Missouri, United States

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Hooksett, New Hampshire, United States

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Cherry Hill, New Jersey, United States

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Morristown, New Jersey, United States

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Paramus, New Jersey, United States

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Sparta, New Jersey, United States

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Albany, New York, United States

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East Setauket, New York, United States

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Mount Kisco, New York, United States

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New York, New York, United States

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New York, New York, United States

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Rochester, New York, United States

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Charleston, North Carolina, United States

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Gastonia, North Carolina, United States

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Greensboro, North Carolina, United States

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Hickory, North Carolina, United States

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Cleveland, Ohio, United States

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Cleveland, Ohio, United States

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Columbus, Ohio, United States

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Middletown, Ohio, United States

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Drexel Hill, Pennsylvania, United States

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Philadelphia, Pennsylvania, United States

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Charleston, South Carolina, United States

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Chattanooga, Tennessee, United States

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Germantown, Tennessee, United States

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Memphis, Tennessee, United States

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Austin, Texas, United States

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Austin, Texas, United States

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Bedford, Texas, United States

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Dallas, Texas, United States

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Dallas, Texas, United States

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Dallas, Texas, United States

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Duncanville, Texas, United States

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El Paso, Texas, United States

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Fort Worth, Texas, United States

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Houston, Texas, United States

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Houston, Texas, United States

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Round Rock, Texas, United States

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San Antonio, Texas, United States

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Tyler, Texas, United States

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Waco, Texas, United States

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Ogden, Utah, United States

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Chesapeake, Virginia, United States

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Fairfax, Virginia, United States

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Richlands, Virginia, United States

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Kirkland, Washington, United States

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Seattle, Washington, United States

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Vancouver, Washington, United States

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Yakima, Washington, United States

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Capital Federal, Buenos Aires, Argentina

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Ciudad Autonoma de Buenos Aires, Buenos Aires, Argentina

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Ciudad Autonoma de Buenos Aires, Buenos Aires, Argentina

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Córdoba, Córdoba Province, Argentina

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Neuquén, Neuquén Province, Argentina

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Rosario, Santa Fe Province, Argentina

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Santa Fe, Santa Fe Province, Argentina

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Buenos Aires, , Argentina

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Quilmes, , Argentina

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San Miguel de Tucumán, , Argentina

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Campbelltown, New South Wales, Australia

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Darlinghurst, New South Wales, Australia

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Kogarah, New South Wales, Australia

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Liverpool, New South Wales, Australia

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North Sydney, New South Wales, Australia

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Douglas, Queensland, Australia

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Herston, Queensland, Australia

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Redcliffe, Queensland, Australia

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South Brisbane, Queensland, Australia

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Bedford Park, South Australia, Australia

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Elizabeth Vale, South Australia, Australia

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Woodville, South Australia, Australia

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Box Hill, Victoria, Australia

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East Melbourne, Victoria, Australia

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Fitzroy, Victoria, Australia

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Footscray, Victoria, Australia

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Heidelberg, Victoria, Australia

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Parkville, Victoria, Australia

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Ringwood East, Victoria, Australia

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Wodonga, Victoria, Australia

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Nedlands, Western Australia, Australia

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Perth, Western Australia, Australia

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Brussels, , Belgium

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Belo Horizonte, Minas Gerais, Brazil

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Rio de Janeiro, Rio de Janeiro, Brazil

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Porto Alegre, Rio Grande do Sul, Brazil

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Porto Alegre, Rio Grande do Sul, Brazil

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Santo André, São Paulo, Brazil

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São Paulo, São Paulo, Brazil

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St. John's, Newfoundland and Labrador, Canada

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Halifax, Nova Scotia, Canada

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Barrie, Ontario, Canada

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Brampton, Ontario, Canada

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Kingston, Ontario, Canada

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London, Ontario, Canada

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Mississauga, Ontario, Canada

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Oshawa, Ontario, Canada

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Ottawa, Ontario, Canada

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Toronto, Ontario, Canada

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Toronto, Ontario, Canada

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Toronto, Ontario, Canada

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Toronto, Ontario, Canada

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Greenfield Park, Quebec, Canada

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Montreal, Quebec, Canada

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Québec, Quebec, Canada

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Saskatoon, Saskatchewan, Canada

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Viña del Mar, Región de Valparaíso, Chile

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Santiago, Región Metro de Santiago, Chile

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Santiago, Región Metro de Santiago, Chile

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Santiago, Región Metro de Santiago, Chile

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Guangzhou, Guangdong, China

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Wuhan, Hubei, China

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Jinan, Shandong, China

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Beijing, , China

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Beijing, , China

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Beijing, , China

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Shanghai, , China

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Tianjin, , China

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Osijek, , Croatia

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Pula, , Croatia

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Rijeka, , Croatia

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Split, , Croatia

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Zagreb, , Croatia

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Brno, , Czechia

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Prague, , Czechia

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Prague, , Czechia

GSK Investigational Site

Aalborg, , Denmark

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Copenhagen, , Denmark

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Esbjerg, , Denmark

GSK Investigational Site

Herlev, , Denmark

GSK Investigational Site

Næstved, , Denmark

GSK Investigational Site

Odense, , Denmark

GSK Investigational Site

Roskilde, , Denmark

GSK Investigational Site

Vejle, , Denmark

GSK Investigational Site

Angers, , France

GSK Investigational Site

Besançon, , France

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Bordeaux, , France

GSK Investigational Site

Caen, , France

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Clermont-Ferrand, , France

GSK Investigational Site

Colmar, , France

GSK Investigational Site

Dijon, , France

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Lille, , France

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Lille, , France

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Lyon, , France

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Lyon, , France

GSK Investigational Site

Marseille, , France

GSK Investigational Site

Montbéliard, , France

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Montpellier, , France

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Nantes, , France

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Nice, , France

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Paris, , France

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Reims, , France

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Rennes, , France

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Saint-Cloud, , France

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Saint-Grégoire, , France

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Saint-Herblain, , France

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Strasbourg, , France

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Toulouse, , France

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Toulouse, , France

GSK Investigational Site

Tourcoing, , France

GSK Investigational Site

Vandœuvre-lès-Nancy, , France

GSK Investigational Site

Villejuif, , France

GSK Investigational Site

Villejuif, , France

GSK Investigational Site

Freiburg im Breisgau, Baden-Wurttemberg, Germany

GSK Investigational Site

Heidelberg, Baden-Wurttemberg, Germany

GSK Investigational Site

Konstanz, Baden-Wurttemberg, Germany

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Mannheim, Baden-Wurttemberg, Germany

GSK Investigational Site

Mayen, Baden-Wurttemberg, Germany

GSK Investigational Site

Mutlangen, Baden-Wurttemberg, Germany

GSK Investigational Site

Schwetzingen, Baden-Wurttemberg, Germany

GSK Investigational Site

Singen, Baden-Wurttemberg, Germany

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Stuttgart, Baden-Wurttemberg, Germany

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Stuttgart, Baden-Wurttemberg, Germany

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Tübingen, Baden-Wurttemberg, Germany

GSK Investigational Site

Ulm, Baden-Wurttemberg, Germany

GSK Investigational Site

Amberg, Bavaria, Germany

GSK Investigational Site

Aschaffenburg, Bavaria, Germany

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Bayreuth, Bavaria, Germany

GSK Investigational Site

Deggendorf, Bavaria, Germany

GSK Investigational Site

Ebersberg, Bavaria, Germany

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Eggenfelden, Bavaria, Germany

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Erlangen, Bavaria, Germany

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Fürth, Bavaria, Germany

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Kempten (Allgäu), Bavaria, Germany

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Krumbach, Bavaria, Germany

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Marktredwitz, Bavaria, Germany

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Memmingen, Bavaria, Germany

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Munich, Bavaria, Germany

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Munich, Bavaria, Germany

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Munich, Bavaria, Germany

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Munich, Bavaria, Germany

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Munich, Bavaria, Germany

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Rehling, Bavaria, Germany

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Rosenheim, Bavaria, Germany

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Roth, Bavaria, Germany

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Schwandorf in Bayern, Bavaria, Germany

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Weiden, Bavaria, Germany

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Cottbus, Brandenburg, Germany

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Fürstenwalde, Brandenburg, Germany

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Bremen, City state Bremen, Germany

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Bremen, City state Bremen, Germany

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Hamburg, City state of Hamburg, Germany

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Hamburg, City state of Hamburg, Germany

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Hamburg, City state of Hamburg, Germany

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Frankfurt am Main, Hesse, Germany

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Frankfurt am Main, Hesse, Germany

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Frankfurt am Main, Hesse, Germany

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Frankfurt am Main, Hesse, Germany

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Kassel, Hesse, Germany

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Kassel, Hesse, Germany

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Wiesbaden, Hesse, Germany

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Goslar, Lower Saxony, Germany

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Hanover, Lower Saxony, Germany

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Hildesheim, Lower Saxony, Germany

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Salzgitter, Lower Saxony, Germany

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Güstrow, Mecklenburg-Vorpommern, Germany

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Bochum, North Rhine-Westphalia, Germany

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Bonn, North Rhine-Westphalia, Germany

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Cologne, North Rhine-Westphalia, Germany

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Cologne, North Rhine-Westphalia, Germany

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Duisburg, North Rhine-Westphalia, Germany

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Duisburg, North Rhine-Westphalia, Germany

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Düsseldorf, North Rhine-Westphalia, Germany

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Essen, North Rhine-Westphalia, Germany

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Herne, North Rhine-Westphalia, Germany

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Hilden, North Rhine-Westphalia, Germany

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Mülheim, North Rhine-Westphalia, Germany

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Porta Westfalica, North Rhine-Westphalia, Germany

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Recklinghausen, North Rhine-Westphalia, Germany

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Troisdorf, North Rhine-Westphalia, Germany

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Velbert, North Rhine-Westphalia, Germany

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Witten, North Rhine-Westphalia, Germany

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Koblenz, Rhineland-Palatinate, Germany

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Mainz, Rhineland-Palatinate, Germany

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Homburg/Saar, Saarland, Germany

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Neunkirchen, Saarland, Germany

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Saarbrücken, Saarland, Germany

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Chemnitz, Saxony, Germany

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Dresden, Saxony, Germany

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Kauschwitz, Saxony, Germany

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Neustadt, Saxony, Germany

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Spremberg, Saxony, Germany

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Zittau, Saxony, Germany

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Zwickau, Saxony, Germany

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Blankenburg, Saxony-Anhalt, Germany

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Halle, Saxony-Anhalt, Germany

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Magdeburg, Saxony-Anhalt, Germany

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Magdeburg, Saxony-Anhalt, Germany

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Stendal, Saxony-Anhalt, Germany

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Kiel, Schleswig-Holstein, Germany

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Lübeck, Schleswig-Holstein, Germany

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Berlin, State of Berlin, Germany

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Berlin, State of Berlin, Germany

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Berlin, State of Berlin, Germany

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Berlin, State of Berlin, Germany

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Berlin, State of Berlin, Germany

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Berlin, State of Berlin, Germany

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Berlin, State of Berlin, Germany

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Eisenach, Thuringia, Germany

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Jena, Thuringia, Germany

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Athens, , Greece

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Athens, , Greece

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Athens, , Greece

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Chania, , Greece

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Heraklion, Crete, , Greece

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Hong Kong, , Hong Kong

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Shatin, , Hong Kong

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Wan Chai, , Hong Kong

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Budapest, , Hungary

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Budapest, , Hungary

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Győr, , Hungary

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Kaposvár, , Hungary

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Kistarcsa, , Hungary

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Pécs, , Hungary

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Szeged, , Hungary

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Chennai, , India

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Hyderabad, , India

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Jaipur, , India

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Mumbai, , India

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New Delhi, , India

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Pune, , India

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Ashkelon, , Israel

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Haifa, , Israel

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Jerusalem, , Israel

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Kfar Saba, , Israel

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Ramat Gan, , Israel

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Rehovot, , Israel

GSK Investigational Site

Tel Aviv, , Israel

GSK Investigational Site

Avellino, Campania, Italy

GSK Investigational Site

Piacenza, Emilia-Romagna, Italy

GSK Investigational Site

Genoa, Liguria, Italy

GSK Investigational Site

Sassari, Sardinia, Italy

GSK Investigational Site

Perugia, Umbria, Italy

GSK Investigational Site

Negrar (Verona), Veneto, Italy

GSK Investigational Site

Liepāja, , Latvia

GSK Investigational Site

Riga, , Latvia

GSK Investigational Site

Riga, , Latvia

GSK Investigational Site

Kaunas, , Lithuania

GSK Investigational Site

Klaipėda, , Lithuania

GSK Investigational Site

Vilnius, , Lithuania

GSK Investigational Site

Chihuahua City, Chihuahua, Mexico

GSK Investigational Site

Mérida, Yucatán, Mexico

GSK Investigational Site

DF., , Mexico

GSK Investigational Site

Mexico City, , Mexico

GSK Investigational Site

México D.F., , Mexico

GSK Investigational Site

Auckland, , New Zealand

GSK Investigational Site

Christchurch, , New Zealand

GSK Investigational Site

Hamilton, , New Zealand

GSK Investigational Site

Lima, Lima Province, Peru

GSK Investigational Site

Lima, Lima Province, Peru

GSK Investigational Site

Lima, Lima Province, Peru

GSK Investigational Site

Baguio City, Benguet, , Philippines

GSK Investigational Site

Cebu, , Philippines

GSK Investigational Site

Pasig, , Philippines

GSK Investigational Site

Quezon City, , Philippines

GSK Investigational Site

Bydgoszcz, , Poland

GSK Investigational Site

Krakow, , Poland

GSK Investigational Site

Olsztyn, , Poland

GSK Investigational Site

Olsztyn, , Poland

GSK Investigational Site

Torun, , Poland

GSK Investigational Site

Warsaw, , Poland

GSK Investigational Site

Moscow, , Russia

GSK Investigational Site

Moscow, , Russia

GSK Investigational Site

Moscow, , Russia

GSK Investigational Site

Ryazan, , Russia

GSK Investigational Site

Saint Petersburg, , Russia

GSK Investigational Site

Saint Petersburg, , Russia

GSK Investigational Site

Yaroslavl, , Russia

GSK Investigational Site

Banská Bystrica, , Slovakia

GSK Investigational Site

Bardejov, , Slovakia

GSK Investigational Site

Bratislava, , Slovakia

GSK Investigational Site

Nitra, , Slovakia

GSK Investigational Site

Tygerberg, Western Province, South Africa

GSK Investigational Site

Athlone Park, Amanzimtoti, , South Africa

GSK Investigational Site

Groenkloof, , South Africa

GSK Investigational Site

Kraaifontein, , South Africa

GSK Investigational Site

Overport, , South Africa

GSK Investigational Site

Parktown, , South Africa

GSK Investigational Site

Port Elizabeth, , South Africa

GSK Investigational Site

Sandton, , South Africa

GSK Investigational Site

Saxonwold, Johannesburg, , South Africa

GSK Investigational Site

Goyang-si, Gyeonggi-do, , South Korea

GSK Investigational Site

Seoul, , South Korea

GSK Investigational Site

Seoul, , South Korea

GSK Investigational Site

Songpa-gu, Seoul, , South Korea

GSK Investigational Site

Alcorcón, , Spain

GSK Investigational Site

Barcelona, , Spain

GSK Investigational Site

Barcelona, , Spain

GSK Investigational Site

Cáceres, , Spain

GSK Investigational Site

Girona, , Spain

GSK Investigational Site

Jaén, , Spain

GSK Investigational Site

Lleida, , Spain

GSK Investigational Site

Llobregat, , Spain

GSK Investigational Site

Madrid, , Spain

GSK Investigational Site

Madrid, , Spain

GSK Investigational Site

Mataró, , Spain

GSK Investigational Site

Ourense, , Spain

GSK Investigational Site

Palma de Mallorca, , Spain

GSK Investigational Site

Palma de Mallorca, , Spain

GSK Investigational Site

Santa Cruz de Tenerife, , Spain

GSK Investigational Site

Santander, , Spain

GSK Investigational Site

Santiago de Compostela, , Spain

GSK Investigational Site

Valencia, , Spain

GSK Investigational Site

Zaragoza, , Spain

GSK Investigational Site

Dnipro, , Ukraine

GSK Investigational Site

Kyiv, , Ukraine

GSK Investigational Site

Lviv, , Ukraine

GSK Investigational Site

Uzhhorod, , Ukraine

GSK Investigational Site

Chelmsford, Essex, United Kingdom

GSK Investigational Site

Manchester, Lancashire, United Kingdom

GSK Investigational Site

Sutton, Surrey, United Kingdom

GSK Investigational Site

Bournemouth, , United Kingdom

GSK Investigational Site

Edgbaston, Birmingham, , United Kingdom

GSK Investigational Site

Glasgow, , United Kingdom

GSK Investigational Site

Lindley, , United Kingdom

GSK Investigational Site

London, , United Kingdom

GSK Investigational Site

London, , United Kingdom

GSK Investigational Site

London, , United Kingdom

GSK Investigational Site

London, , United Kingdom

GSK Investigational Site

Maidstone, , United Kingdom

GSK Investigational Site

Manchester, , United Kingdom

GSK Investigational Site

Newcastle upon Tyne, , United Kingdom

GSK Investigational Site

Nottingham, , United Kingdom

GSK Investigational Site

Sheffield, , United Kingdom

GSK Investigational Site

Shrewsbury, , United Kingdom

Countries

United States; Argentina; Australia; Belgium; Brazil; Canada; Chile; China; Croatia; Czechia; Denmark; France; Germany; Greece; Hong Kong; Hungary; India; Israel; Italy; Latvia; Lithuania; Mexico; New Zealand; Peru; Philippines; Poland; Russia; Slovakia; South Africa; South Korea; Spain; Ukraine; United Kingdom

References

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.

Reference Type: DERIVED

PMID: 23234763 (View on PubMed)

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.

Reference Type: BACKGROUND

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.

Reference Type: DERIVED

PMID: 25752740 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 24687830 (View on PubMed)

Other Identifiers

EGF105485

Identifier Type: -

Identifier Source: org_study_id