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A Randomized, Phase III, Open-label Study of Lapatinib Plus Trastuzumab Versus Trastuzumab as Continued HER2 Suppression Therapy After Completion of First- or Second-line Trastuzumab Plus Chemotherapy in Subjects With HER2-positive Metastatic Breast Cancer

Phase 3
18 Years
Open (Enrolling)

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Trial Information

A Randomized, Phase III, Open-label Study of Lapatinib Plus Trastuzumab Versus Trastuzumab as Continued HER2 Suppression Therapy After Completion of First- or Second-line Trastuzumab Plus Chemotherapy in Subjects With HER2-positive Metastatic Breast Cancer

Inclusion Criteria:

- Signed the informed consent form (ICF)

- Female, ≥18 years of age

- Histologically verified breast cancer with distant metastases (metastatic breast

- Documentation of HER2 overexpression or gene amplification in the invasive component
of either the primary tumor or metastatic disease site defined as:

- 3+ by IHC and/or

- HER2/neu gene amplification by fluorescence, chromogenic or silver in situ
hybridization [FISH, CISH or SISH; >6 HER2/neu gene copies per nucleus or a FISH,
CISH or SISH HER2 gene copies to chromosome 17 signal ratio of ≥2.0]

- Completed 12 to 24 weeks of first- or second-line treatment with trastuzumab in
combination with chemotherapy

- Either complete disappearance of all lesions, or persistence of metastatic disease
(stable disease) without unequivocal progression or the occurrence of new lesions

- Documentation of lesion response during the course of therapy received prior to
randomization (i.e., improvement or no worsening of tumor burden; the absence of new

- Measurable disease is not required for study participation

- No known or suspected (associated neurological signs and symptoms) brain metastases
(including leptomeningeal involvement)

- Stable brain metastasis (defined as asymptomatic and off steroids ≥3 months) are
permitted in subjects entering LPT112515 on second-line treatment (completed 12-24
weeks of second-line treatment with trastuzumab plus chemotherapy)

- Baseline of Left Ventricular Ejection Fraction (LVEF) ≥50% measured by
echocardiography (ECHO) or multi-gated acquisition scan (MUGA)

- Completion of screening assessments (Refer to protocol for further details)

- Have adequate marrow and organ function as defined in Table 2. Table 2 Laboratory
Values SYSTEM LABORATORY VALUES Hematologic ANC ≥1.5 x 109/L Hemoglobin ≥9 g/dL
(after transfusion if needed) Platelets ≥100 x 109/L Hepatic Albumin ≥2.5 g/dL Serum
bilirubin ≤1.5 x ULN unless due to Gilbert's syndrome AST and ALT ≤3 x ULN Renal
Calculated creatinine clearance* ≥ 40 mL/min Serum Creatinine ≤1.5 mg/dL or
132.6μmol/L *Calculated by the Cockcroft-Gault Equation (Refer to protocol for
details) Abbreviations: ANC, absolute neutrophil count; ULN, upper limit of normal;
AST, aspartate aminotransferase; ALT, alanine aminotransferase

Exclusion Criteria:

- History of other malignancy. Subjects who have been disease-free for 5 years or
subjects with a history of completely resected non-melanoma skin cancer (basal or
squamous) are eligible

- Eastern Cooperative Oncology Group (ECOG) Performance Status >2

- Concurrent anti-cancer treatment, except anti-hormonal therapy for subjects with
hormone receptor positive breast cancer

- Concurrent treatment with an investigational agent

- Prior treatment with anti-HER2 therapy, except trastuzumab or lapatinib

- Concurrent treatment with protocol-defined prohibited medications (refer to protocol
for details)

- Serious cardiac illness or medical condition including but not confined to:

- Uncontrolled arrhythmias

- Uncontrolled or symptomatic angina

- History of congestive heart failure (CHF)

- Myocardial infarction <6 months from study entry

- Acute or current active (requiring anti-viral therapy) hepatic or biliary disease
(with the exception of subjects with Gilbert's syndrome, asymptomatic gallstones,
liver metastases or stable chronic liver disease per investigator assessment)

- Concurrent disease or condition that may interfere with study participation, or any
serious medical disorder that would interfere with the subject's safety (for example,
active or uncontrolled infection or any psychiatric condition prohibiting
understanding or rendering of informed consent)

- Women of childbearing potential, including women whose last menstrual period was <12
months ago (unless surgically sterile) who are unable or unwilling to use adequate
contraceptive measures during the study treatment period. Adequate contraception
includes intra-uterine device, barrier methods with spermicide, or oral
contraceptives (unless clinically contraindicated for the subject population or per
local practice, refer to protocol for further details)

- Pregnant or lactating females

- Any clinically significant gastrointestinal abnormalities that may alter absorption
such as malabsorption syndrome or major resection of the stomach or bowels.

- Known immediate or delayed hypersensitivity reaction or idiosyncrasy to drugs
chemically related to any of the study agents or their excipients that, in the
opinion of the Investigator or GSK medical monitor , contra-indicates participation

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Progression-free survival

Outcome Time Frame:

Time from randomization until disease progression or death

Safety Issue:


Principal Investigator

GSK Clinical Trials

Investigator Role:

Study Director

Investigator Affiliation:



United States: Food and Drug Administration

Study ID:




Start Date:

January 2010

Completion Date:

August 2014

Related Keywords:

  • Cancer



GSK Investigational Site Phoenix, Arizona  85013 - 4496
GSK Investigational Site Bakersfield, California  93309
GSK Investigational Site Gainesville, Florida  32610
GSK Investigational Site Springfield, Massachusetts  01107
GSK Investigational Site St. Louis, Missouri  63141
GSK Investigational Site St. Louis, Montana  63110
GSK Investigational Site Raleigh, North Carolina  27609
GSK Investigational Site Fort Worth, Texas  76104
GSK Investigational Site Savannah, Georgia  31405
GSK Investigational Site Park Ridge, Illinois  60068
GSK Investigational Site Baltimore, Maryland  21201
GSK Investigational Site Pittsburgh, Pennsylvania  15213
GSK Investigational Site Salem, Virginia  24153
GSK Investigational Site Henderson, Nevada  89014
GSK Investigational Site Salt Lake City, Utah  84107
GSK Investigational Site Seattle, Washington  98133