Lapatinib In Combination With Trastuzumab Versus Lapatinib Monotherapy In Subjects With HER2-positive Metastatic Breast Cancer

A Randomized, Multicenter, Open-Label, Phase III Study of Lapatinib in Combination With Trastuzumab Versus Lapatinib Monotherapy in Subjects With HER2-positive Metastatic Breast Cancer Whose Disease Has Progressed on Trastuzumab-Containing Regimens

This study will evaluate and compare the safety and efficacy of lapatinib in combination with trastuzumab versus lapatinib monotherapy in subjects with HER2-positive metastatic breast cancer.

Study Overview

• Status: Completed
• Conditions: Neoplasms, Breast
• Intervention / Treatment: Drug: Lapatinib; Biological: Trastuzumab

• Study Type: Interventional
• Enrollment (Actual): 296
• Phase: Phase 3

Contacts and Locations

Study Locations

• Austria
  • Salzburg, Austria, A-5020
    • GSK Investigational Site
  • Vienna, Austria, A-1090
    • GSK Investigational Site
• Bulgaria
  • Plovdiv, Bulgaria, 4000
    • GSK Investigational Site
  • Sofia, Bulgaria, 1572
    • GSK Investigational Site
• Canada
  • Quebec
    • Laval, Quebec, Canada, H7M 3L9
      • GSK Investigational Site
    • Montreal, Quebec, Canada, H4J 1C5
      • GSK Investigational Site
    • Montreal, Quebec, Canada, H2L 4M1
      • GSK Investigational Site
• Croatia
  • Split, Croatia, 21000
    • GSK Investigational Site
  • Zagreb, Croatia, 10 000
    • GSK Investigational Site
• Czech Republic
  • Brno, Czech Republic, 656 53
    • GSK Investigational Site
  • Praha 5, Czech Republic, 150 08
    • GSK Investigational Site
  • Praha 8, Czech Republic, 180 00
    • GSK Investigational Site
• Finland
  • Tampere, Finland, 33520
    • GSK Investigational Site
• Germany
  • Berlin, Germany, 10367
    • GSK Investigational Site
  • Berlin, Germany, 12200
    • GSK Investigational Site
  • Hamburg, Germany, 22457
    • GSK Investigational Site
  • Hamburg, Germany, 22767
    • GSK Investigational Site
  • Hamburg, Germany, 22081
    • GSK Investigational Site
  • Baden-Wuerttemberg
    • Heidelberg, Baden-Wuerttemberg, Germany, 69115
      • GSK Investigational Site
    • Stuttgart, Baden-Wuerttemberg, Germany, 70199
      • GSK Investigational Site
    • Stuttgart, Baden-Wuerttemberg, Germany, 70190
      • GSK Investigational Site
  • Bayern
    • Augsburg, Bayern, Germany, 86150
      • GSK Investigational Site
    • Coburg, Bayern, Germany, 96450
      • GSK Investigational Site
    • Muenchen, Bayern, Germany, 80331
      • GSK Investigational Site
  • Brandenburg
    • Fuerstenwalde, Brandenburg, Germany, 15517
      • GSK Investigational Site
  • Hessen
    • Frankfurt, Hessen, Germany, 60596
      • GSK Investigational Site
  • Niedersachsen
    • Leer, Niedersachsen, Germany, 26789
      • GSK Investigational Site
  • Nordrhein-Westfalen
    • Herne, Nordrhein-Westfalen, Germany, 44623
      • GSK Investigational Site
    • Troisdorf, Nordrhein-Westfalen, Germany, 53840
      • GSK Investigational Site
    • Velbert, Nordrhein-Westfalen, Germany, 42551
      • GSK Investigational Site
  • Saarland
    • Saarbruecken, Saarland, Germany, 66113
      • GSK Investigational Site
  • Sachsen-Anhalt
    • Halle, Sachsen-Anhalt, Germany, 06120
      • GSK Investigational Site
    • Magdeburg, Sachsen-Anhalt, Germany, 39108
      • GSK Investigational Site
  • Schleswig-Holstein
    • Kiel, Schleswig-Holstein, Germany, 24103
      • GSK Investigational Site
• Greece
  • Athens, Greece, 115 22
    • GSK Investigational Site
  • Athens, Greece, 185 37
    • GSK Investigational Site
  • Athens, Greece, 13122
    • GSK Investigational Site
  • Neo Faliro, Greece, 18547
    • GSK Investigational Site
• Italy
  • Emilia-Romagna
    • Ravenna, Emilia-Romagna, Italy, 48100
      • GSK Investigational Site
  • Lazio
    • Roma, Lazio, Italy, 00144
      • GSK Investigational Site
  • Lombardia
    • Rozzano (MI), Lombardia, Italy, 20089
      • GSK Investigational Site
  • Puglia
    • Bari, Puglia, Italy, 70126
      • GSK Investigational Site
    • Lecce, Puglia, Italy, 73100
      • GSK Investigational Site
  • Umbria
    • Perugia, Umbria, Italy, 06156
      • GSK Investigational Site
• Poland
  • Bialystok, Poland, 15-027
    • GSK Investigational Site
  • Olsztyn, Poland, 10-228
    • GSK Investigational Site
  • Olsztyn, Poland, 10-226
    • GSK Investigational Site
  • Warszawa, Poland, 02-781
    • GSK Investigational Site
  • Wroclaw, Poland, 53-413
    • GSK Investigational Site
• Spain
  • Barcelona, Spain, 08035
    • GSK Investigational Site
  • Hospitalet de Llobregat (Barcelona), Spain, 08907
    • GSK Investigational Site
  • Lerida, Spain, 25198
    • GSK Investigational Site
  • Madrid, Spain, 28041
    • GSK Investigational Site
  • Santa Cruz de Tenerife, Spain, 38320
    • GSK Investigational Site
  • Valencia, Spain, 46010
    • GSK Investigational Site
• United Kingdom
  • Huddersfield, United Kingdom, HD3 3EA
    • GSK Investigational Site
  • Ipswich, United Kingdom, IP4 5PD
    • GSK Investigational Site
  • London, United Kingdom, SE1 9RT
    • GSK Investigational Site
• United States
  • Arizona
    • Phoenix, Arizona, United States, 85012
      • GSK Investigational Site
    • Sedona, Arizona, United States, 86336
      • GSK Investigational Site
  • California
    • Highland, California, United States, 92346
      • GSK Investigational Site
    • Sacramento, California, United States, 95819
      • GSK Investigational Site
    • San Diego, California, United States, 92120
      • GSK Investigational Site
    • San Francisco, California, United States, 94115-1710
      • GSK Investigational Site
    • Santa Rosa, California, United States, 95403-1757
      • GSK Investigational Site
    • Vallejo, California, United States, 94589
      • GSK Investigational Site
  • Delaware
    • Newark, Delaware, United States, 19713
      • GSK Investigational Site
  • Florida
    • Boca Raton, Florida, United States, 33428
      • GSK Investigational Site
    • Fort Myers, Florida, United States, 33916
      • GSK Investigational Site
    • Gainesville, Florida, United States, 32605
      • GSK Investigational Site
    • Hollywood, Florida, United States, 33021
      • GSK Investigational Site
    • Jacksonville, Florida, United States, 32256
      • GSK Investigational Site
    • Miami, Florida, United States, 33136
      • GSK Investigational Site
    • Ocala, Florida, United States, 34474
      • GSK Investigational Site
    • Ocoee, Florida, United States, 34761
      • GSK Investigational Site
    • Orlando, Florida, United States, 32804
      • GSK Investigational Site
    • West Palm Beach, Florida, United States, 33401
      • GSK Investigational Site
  • Georgia
    • Lawrenceville, Georgia, United States, 30046-7650
      • GSK Investigational Site
  • Illinois
    • Niles, Illinois, United States, 60714
      • GSK Investigational Site
  • Indiana
    • Indianapolis, Indiana, United States, 46202
      • GSK Investigational Site
    • Indianapolis, Indiana, United States, 46227
      • GSK Investigational Site
    • Terre Haute, Indiana, United States, 47802
      • GSK Investigational Site
  • Iowa
    • Cedar Rapids, Iowa, United States, 52403
      • GSK Investigational Site
  • Kansas
    • Kansas City, Kansas, United States, 66103
      • GSK Investigational Site
    • Overland Park, Kansas, United States, 66210
      • GSK Investigational Site
  • Massachusetts
    • Boston, Massachusetts, United States, 02115
      • GSK Investigational Site
  • Minnesota
    • Minneapolis, Minnesota, United States, 55404
      • GSK Investigational Site
    • Robbinsdale, Minnesota, United States, 55422
      • GSK Investigational Site
  • Missouri
    • Columbia, Missouri, United States, 65201
      • GSK Investigational Site
    • St. Joseph, Missouri, United States, 64507
      • GSK Investigational Site
  • Nevada
    • Las Vegas, Nevada, United States, 89135
      • GSK Investigational Site
    • Las Vegas, Nevada, United States, 89109
      • GSK Investigational Site
  • New Jersey
    • Montclair, New Jersey, United States, 07042
      • GSK Investigational Site
    • Morristown, New Jersey, United States, 07962
      • GSK Investigational Site
    • New Brunswick, New Jersey, United States, 08901
      • GSK Investigational Site
    • Summit, New Jersey, United States, 07901
      • GSK Investigational Site
    • Voorhees, New Jersey, United States, 08043
      • GSK Investigational Site
  • New York
    • Albany, New York, United States, 12208
      • GSK Investigational Site
    • New York, New York, United States, 10016
      • GSK Investigational Site
  • North Carolina
    • Cary, North Carolina, United States, 27511
      • GSK Investigational Site
    • Charlotte, North Carolina, United States, 28203
      • GSK Investigational Site
    • Durham, North Carolina, United States, 27710
      • GSK Investigational Site
    • Hickory, North Carolina, United States, 28602
      • GSK Investigational Site
  • Ohio
    • Canton, Ohio, United States, 44710
      • GSK Investigational Site
    • Kettering, Ohio, United States, 45409
      • GSK Investigational Site
  • Oklahoma
    • Oklahoma City, Oklahoma, United States, 73112
      • GSK Investigational Site
    • Tulsa, Oklahoma, United States, 74136-1902
      • GSK Investigational Site
  • Pennsylvania
    • Bryn Mawr, Pennsylvania, United States, 19010
      • GSK Investigational Site
    • Hershey, Pennsylvania, United States, 17033
      • GSK Investigational Site
    • Kingston, Pennsylvania, United States, 18704
      • GSK Investigational Site
    • Philadelphia, Pennsylvania, United States, 19104
      • GSK Investigational Site
    • Pittsburgh, Pennsylvania, United States, 15213
      • GSK Investigational Site
    • West Reading, Pennsylvania, United States, 19611
      • GSK Investigational Site
  • South Carolina
    • Greenville, South Carolina, United States, 29605
      • GSK Investigational Site
  • Tennessee
    • Nashville, Tennessee, United States, 37203
      • GSK Investigational Site
  • Texas
    • Arlington, Texas, United States, 76014
      • GSK Investigational Site
    • Austin, Texas, United States, 78731
      • GSK Investigational Site
    • Beaumont, Texas, United States, 77702-1449
      • GSK Investigational Site
    • Bedford, Texas, United States, 76022
      • GSK Investigational Site
    • Dallas, Texas, United States, 75246
      • GSK Investigational Site
    • Dallas, Texas, United States, 75230
      • GSK Investigational Site
    • Dallas, Texas, United States, 75231
      • GSK Investigational Site
    • Dallas, Texas, United States, 75237
      • GSK Investigational Site
    • Denton, Texas, United States, 76210
      • GSK Investigational Site
    • El Paso, Texas, United States, 79915
      • GSK Investigational Site
    • Fort Worth, Texas, United States, 76104
      • GSK Investigational Site
    • Fredericksburg, Texas, United States, 78624
      • GSK Investigational Site
    • Lewisville, Texas, United States, 75067
      • GSK Investigational Site
    • Longview, Texas, United States, 75601
      • GSK Investigational Site
    • McAllen, Texas, United States, 78503-1298
      • GSK Investigational Site
    • Mesquite, Texas, United States, 75150
      • GSK Investigational Site
    • Midland, Texas, United States, 79701
      • GSK Investigational Site
    • Odessa, Texas, United States, 79761
      • GSK Investigational Site
    • Paris, Texas, United States, 75460
      • GSK Investigational Site
    • Tyler, Texas, United States, 75702
      • GSK Investigational Site
    • Waco, Texas, United States, 76712
      • GSK Investigational Site
  • Virginia
    • Norfolk, Virginia, United States, 23502
      • GSK Investigational Site
    • Richmond, Virginia, United States, 23230
      • GSK Investigational Site
    • Salem, Virginia, United States, 24153
      • GSK Investigational Site
  • Washington
    • Edmunds, Washington, United States, 98026
      • GSK Investigational Site
    • Seattle, Washington, United States, 98133
      • GSK Investigational Site
    • Spokane, Washington, United States, 99202
      • GSK Investigational Site
    • Vancouver, Washington, United States, 98684
      • GSK Investigational Site
    • Yakima, Washington, United States, 98902
      • GSK Investigational Site
  • Wisconsin
    • Green Bay, Wisconsin, United States, 54301
      • GSK Investigational Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

• Signed informed consent.
• Female ≥18 years. Women of childbearing potential must have a negative serum pregnancy test at screening and must use an approved contraceptive method, if appropriate (for example, intrauterine device [IUD], birth control pills, or barrier device) beginning 2 weeks before the first dose of investigational product and for 28 days after the final dose of investigational product.
• Metastatic breast cancer, histologically/cytologically confirmed. If the disease is restricted to a solitary lesion, its neoplastic nature must be confirmed by cytology or histology.
• Subjects must have stage IV breast cancer whereby their disease has progressed in either the adjuvant or metastatic setting. Prior therapies must include, but are not limited to:
• Taxane-containing regimen for at least 4 cycles, or 2 cycles provided disease progression occurred while on taxane.
• Anthracycline-containing regimen for at least 4 cycles, or 2 cycles provided disease progression occurred while on anthracycline.
• Subjects must have documented progression following at least ONE trastuzumab plus cytotoxic chemotherapy or anti-hormonal regimen in the metastatic setting.
• Note: The most recent treatment must have contained trastuzumab, either alone or in combination with other therapy in the metastatic setting, and subjects must have progressed while on this regimen. Progression is defined as either new lesions or a ≥20% increase in the sum of longest diameter (LD) on the progression radiologic scan.
• Subjects must have archived tumor tissue available for testing.
• Documented amplification of the ErbB2 gene by fluorescence in situ hybridization (FISH) or documented overexpression of the ErbB2 protein by IHC in primary or metastatic tumor tissue. The IHC or FISH amplification may be documented by a local or central laboratory for randomization into the study. Subjects may be randomized on the basis of ErbB2 positivity by IHC 3+ overexpression or FISH amplification.
• Lesion eligibility is as follows:
• at least one measurable lesion(s) according to Response Evaluation Criteria in Solid Tumors [RECIST; Therasse, 2000], or
• bone-only disease.
• Note: Tumor lesions which are situated in a previously irradiated field, and have well-defined margins which are located in soft tissue will be defined as measurable disease.
• Subjects with stable CNS metastases defined as asymptomatic and off systemic steroids and anticonvulsants for at least 1 month. Treatment with prophylactic anticonvulsants is permitted, unless listed within the Prohibited Medications (Section 8.2).
• Radiotherapy if received within 2 weeks prior to initiation of investigational product to a limited area (e.g., palliative treatment for painful disease) other than the sole site of measurable disease is allowed; however, subject must have completed treatment and recovered from all treatment-related toxicities prior to administration of the first dose of investigational product.
• With the single exception of prior trastuzumab treatment, all prior chemotherapy, immunotherapy, biologic therapy, or surgery (except for minor surgical procedures) must be discontinued at least 3 weeks prior to the first dose of investigational product. Subjects must have recovered or stabilized sufficiently from treatment-related toxicities prior to administration of the first dose of investigational product.
• Bisphosphonate therapy for bone metastases is allowed; however, treatment must be initiated prior to the first dose of investigational product. Prophylactic use of bisphosphonates is permitted only for the treatment of osteoporosis.
• ECOG Performance Status of 0 to 2.
• Able to swallow and retain oral medication.
• Cardiac ejection fraction within institutional range of normal as measured by echocardiogram. MUGA scans will be accepted in cases where an echocardiogram cannot be performed or is inconclusive. Same modality used at baseline must be used for repeat assessments throughout study.
• Subject must have adequate organ function as defined in Table 1 :
• Table 1 (Definitions for Adequate Hematologic and Hepatic Function)
• SYSTEM (LABORATORY VALUES)
• Hematologic:
• ANC (absolute neutrophil count) (≥ 1x10^9/ L)
• Hemoglobin (≥ 9 g / dL)
• Platelets (≥75x10^9/ L)
• Hepatic
• Albumin (≥ 2.5 g / dL)
• Serum bilirubin (≤ 2 mg / dL)
• AST and ALT (≤ 3 x ULN without liver metastases) (≤ 5 xULN if documented liver metastases)
• Renal
• Serum Creatinine (≤1.5 mg / dL)
• OR -
• Calculated Creatinine Clearance1 (≥40 mL / min)
• Calculated by the Cockcroft and Gault Method.
• Subjects may continue anti-estrogen therapy only if treatment was initiated at least 1 month prior to the first dose of investigational product (IP). After randomization, no anti-hormonal therapy may be initiated.

Exclusion Criteria:

• Pregnant or lactating females.
• Prior therapy with an ErbB1 and/or ErbB2 inhibitor other than trastuzumab.
• Malabsorption syndrome, disease significantly affecting gastrointestinal function, or resection of the stomach or small bowel. Subjects with ulcerative colitis are also excluded.
• History of other malignancy. However, subjects who have been disease-free for 5 years, or subjects with a history of completely resected non-melanoma skin cancer or successfully treated in situ carcinoma are eligible.
• Concurrent disease or condition that would make the subject inappropriate for study participation or any serious medical disorder that would interfere with the subject's safety.
• Unresolved or unstable, serious toxicity from prior administration of another investigational drug and/or of prior cancer treatment.
• Active or uncontrolled infection.
• Dementia, altered mental status, or any psychiatric condition that would prohibit the understanding or rendering of informed consent.
• Known history of uncontrolled or symptomatic angina, arrhythmias, or congestive heart failure.
• Known history or clinical evidence of leptomeningeal carcinomatosis.
• Concurrent cancer therapy (chemotherapy, radiation therapy, immunotherapy, biologic therapy).
• Concurrent treatment with an investigational agent or participation in another clinical trial.
• Used an investigational drug within 3 weeks or 5 half-lives, whichever is longer, preceding the first dose of investigational product.
• Known immediate or delayed hypersensitivity reaction or idiosyncrasy to drugs chemically related to trastuzumab or lapatinib or their excipients.
• Have current active hepatic or biliary disease (with exception of patients with Gilbert's syndrome, asymptomatic gallstones, liver metastases or stable chronic liver disease per investigator assessment).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Arm 1: Lapatinib plus Trastuzumab; Lapatinib 1000mg once daily in combination with trastuzumab 4mg/kg loading dose followed by 2mg/kg weekly	Drug: Lapatinib; oral lapatinib once daily; Other Names: Tykerb; Tyverb; Biological: Trastuzumab; IV trastuzumab 2mg/kg weekly after 4mg/kg loading dose; Other Names: Herceptin
EXPERIMENTAL: Arm 2: Lapatinib; Lapatinib 1500mg once daily	Drug: Lapatinib; oral lapatinib once daily; Other Names: Tykerb; Tyverb

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Progression-Free Survival (PFS)	PFS was defined as the time from randomization until the first documented sign of disease progression or death due to any cause.	Baseline to disease progression or death due to any cause or 30 days after last dose (up to 216 weeks)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall Survival (OS)	OS was defined as the time from randomization until death due to any cause. For participants who did not die, OS was censored at the time of last contact.	Baseline to death or 30 days after last dose for the last participant (up to 216 weeks)
Overall Tumor Response (OR)	OR was defined as the percentage of participants experiencing either a confirmed complete response (CR) or a confirmed partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST) criteria 1.0. CR was defined as the disappearance of all lesions (target and/or non-target). PR was defined as at least a 30% decrease in the sum of the longest dimensions (LD) of target lesions taking as a reference the baseline sum LD, with non-target lesions not increased or absent.	Baseline to disease progression or death or discontinuation from study or 30 days after last dose (up to 216 weeks)
Clinical Benefit Response (CBR)	CBR: percentage of participants with confirmed CR or PR or stable disease (SD) for at least 24 weeks according to RECIST criteria. CR: disappearance of all lesions (target and/or non-target). PR: at least a 30% decrease in the sum of the LD of target lesions taking as reference baseline sum LD, with non-target lesions not increased or absent. SD: neither had sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD) in target lesions, taking as reference the smallest sum LD since treatment started; persistence of 1 or more non-target lesions.	Baseline to disease progression or death or discontinuation from study or 30 days after last dose (up to 216 weeks)
Time to Response (TTR)	TTR was defined as the time from randomization until the first documented evidence of CR or PR (whichever status was recorded first). TTR could not be analyzed because too few participants experienced a confirmed CR or PR.	Baseline until first documented evidence of CR or PR or 30 days after last dose (up to 216 weeks)
Duration of Response (DR)	DR was defined for the subset of participants who showed a confirmed CR or PR, as the time from the first documented evidence of CR or PR until the first documented sign of disease progression or death. Because of the low number of participants experiencing a confirmed response in both treatment arms, analysis for this outcome measure was not performed.	Time from first documented evidence of CR or PR until the first documented sign of disease progression or death or 30 days after last dose (up to 216 weeks)
Time to Progression (TTP)	TTP was defined as the interval between the date of randomization and the earlier of the date of disease progression or death due to breast cancer. Because this outcome measure was confounded by death due to other causes and was similar to PFS, it was not analyzed.	Baseline to disease progression or death or 30 days after last dose (up to 216 weeks)
Change From Baseline in Functional Assessment of Cancer Therapy-Breast (FACT-B) Scores at Week 4, Week 12, Week 16, Week 24, and Conclusion or Withdrawal From Study	Quality of Life (QOL) was assessed using the FACT-B questionnaire, which was a 37-item (27 general and 10 breast cancer-specific questions) self-reporting instrument consisting of 5 dimensions: physical-, social/family-, emotional-, functional-well being, and a breast cancer subscale. Higher scores on the FACT-B scales indicate a higher QOL; each ranging from 0 (not at all) to 4 (very much). The score is transformed for FACT-B and results in a total score ranging from 0 to 144.	Baseline, Week 4, Week 12, Week 16, Week 24, and conclusion or withdrawal from study (up to Week 108)

Collaborators and Investigators

• Sponsor: GlaxoSmithKline

Publications and helpful links

General Publications

• Wu Y, Amonkar MM, Sherrill BH, O'Shaughnessy J, Ellis C, Baselga J, Blackwell KL, Burstein HJ. Impact of lapatinib plus trastuzumab versus single-agent lapatinib on quality of life of patients with trastuzumab-refractory HER2+ metastatic breast cancer. Ann Oncol. 2011 Dec;22(12):2582-2590. doi: 10.1093/annonc/mdr014. Epub 2011 Mar 15. Erratum In: Ann Oncol. 2019 Jun 1;30(6):1019.
• Blackwell KL, Burstein HJ, Storniolo AM, Rugo HS, Sledge G, Aktan G, Ellis C, Florance A, Vukelja S, Bischoff J, Baselga J, O'Shaughnessy J. Overall survival benefit with lapatinib in combination with trastuzumab for patients with human epidermal growth factor receptor 2-positive metastatic breast cancer: final results from the EGF104900 Study. J Clin Oncol. 2012 Jul 20;30(21):2585-92. doi: 10.1200/JCO.2011.35.6725. Epub 2012 Jun 11.

Study record dates

Study Major Dates

• Study Start: November 1, 2005
• Primary Completion (ACTUAL): June 1, 2007
• Study Completion (ACTUAL): October 1, 2010

Study Registration Dates

• First Submitted: May 1, 2006
• First Submitted That Met QC Criteria: May 1, 2006
• First Posted (ESTIMATE): May 3, 2006

Study Record Updates

• Last Update Posted (ESTIMATE): February 26, 2016
• Last Update Submitted That Met QC Criteria: January 28, 2016
• Last Verified: April 1, 2015

More Information

Terms related to this study

• Keywords: EGFR; Metastatic Breast Cancer; lapatinib; MBC; GW572016; ErbB1; ErbB2; Her-2/neu; dual tyrosine kinase inhibitor; FISH amplification
• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Antineoplastic Agents; Antineoplastic Agents, Immunological; Protein Kinase Inhibitors; Trastuzumab; Lapatinib
• Other Study ID Numbers: EGF104900