Continued HER2 Suppression With Lapatinib Plus Trastuzumab Versus Trastuzumab Alone



Status:Completed
Conditions:Breast Cancer, Cancer, Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:5/24/2018
Start Date:January 20, 2010
End Date:March 30, 2018

Use our guide to learn which trials are right for you!

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

This is a randomized, open-label, multi-center Phase III study evaluating the efficacy and
safety of lapatinib in combination with trastuzumab versus trastuzumab alone as continued
HER2 suppression therapy in women with HER2-positive metastatic breast cancer (MBC). Eligible
subjects will have completed 12 to 24 weeks of first- or second-line treatment with
trastuzumab plus chemotherapy, experienced either complete disappearance of all metastatic
lesions, or persistence of metastatic disease (stable disease) without unequivocal
progression or the occurrence of new lesions, and been indicated to continue to receive
trastuzumab alone as maintenance therapy. Eligible subjects entering the LPT112515 study on
first-line treatment will have no known history of central nervous system (CNS) metastases;
subjects entering the study on second-line treatment will have no known history of CNS
metastases or have stable (asymptomatic and off steroids ≥3 months) CNS metastases. The
primary objective of this study is to compare progression-free survival (PFS) in subjects
with HER2-positive MBC randomized to receive treatment with lapatinib plus trastuzumab versus
those randomized to receive trastuzumab alone. The secondary objectives include overall
survival, clinical benefit response rate (CR, PR or SD ≥24 weeks) and the qualitative and
quantitative adverse event profile of the 2 treatment arms. It is estimated that 280 subjects
(140 per group) will be required to observe 193 PFS events.


Inclusion Criteria:

- Signed the informed consent form (ICF)

- Female, ≥18 years of age

- Histologically verified breast cancer with distant metastases (metastatic breast
cancer)

- 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
lesions)

- 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
We found this trial at
97
sites
Chandler, Arizona 85224
?
mi
from
Chandler, AZ
Click here to add this to my saved trials
Abilene, Texas 79606
?
mi
from
Abilene, TX
Click here to add this to my saved trials
Abington, Pennsylvania 19001
?
mi
from
Abington, PA
Click here to add this to my saved trials
Arlington, Virginia 22203
?
mi
from
Arlington, VA
Click here to add this to my saved trials
Arlington Heights, Illinois 60005
?
mi
from
Arlington Heights, IL
Click here to add this to my saved trials
Augusta, Georgia 30904
?
mi
from
Augusta, GA
Click here to add this to my saved trials
Bakersfield, California 93301
?
mi
from
Bakersfield, CA
Click here to add this to my saved trials
Beaumont, Texas 77702
?
mi
from
Beaumont, TX
Click here to add this to my saved trials
Bedford, Texas 76021
?
mi
from
Bedford, TX
Click here to add this to my saved trials
Beverly Hills, California 90211
?
mi
from
Beverly Hills, CA
Click here to add this to my saved trials
Billings, Montana 59102
?
mi
from
Billings, MT
Click here to add this to my saved trials
Boston, Massachusetts 02118
?
mi
from
Boston, MA
Click here to add this to my saved trials
Bountiful, Utah 84010
?
mi
from
Bountiful, UT
Click here to add this to my saved trials
Brownstown, Michigan 48183
?
mi
from
Brownstown, MI
Click here to add this to my saved trials
Burnsville, Minnesota 55337
?
mi
from
Burnsville, MN
Click here to add this to my saved trials
Cary, North Carolina 27511
?
mi
from
Cary, NC
Click here to add this to my saved trials
Chesapeake, Virginia 23320
?
mi
from
Chesapeake, VA
Click here to add this to my saved trials
Chicago, Illinois 60612
?
mi
from
Chicago, IL
Click here to add this to my saved trials
Columbia, Maryland 21044
?
mi
from
Columbia, MD
Click here to add this to my saved trials
Columbia, Missouri 65212
?
mi
from
Columbia, MO
Click here to add this to my saved trials
Coon Rapids, Minnesota 55433
?
mi
from
Coon Rapids, MN
Click here to add this to my saved trials
Dallas, Texas 75216
?
mi
from
Dallas, TX
Click here to add this to my saved trials
Dearborn, Michigan 48123
?
mi
from
Dearborn, MI
Click here to add this to my saved trials
Detroit, Michigan 48202
?
mi
from
Detroit, MI
Click here to add this to my saved trials
Dublin, Georgia 31021
?
mi
from
Dublin, GA
Click here to add this to my saved trials
Edina, Minnesota 55435
?
mi
from
Edina, MN
Click here to add this to my saved trials
Edmonds, Washington 98026
?
mi
from
Edmonds, WA
Click here to add this to my saved trials
El Paso, Texas 79902
?
mi
from
El Paso, TX
Click here to add this to my saved trials
Elizabeth City, North Carolina 27909
?
mi
from
Elizabeth City, NC
Click here to add this to my saved trials
Evanston, Illinois 60201
?
mi
from
Evanston, IL
Click here to add this to my saved trials
Fairfax, Virginia 22031
?
mi
from
Fairfax, VA
Click here to add this to my saved trials
Federal Way, Washington 98003
?
mi
from
Federal Way, WA
Click here to add this to my saved trials
Flagstaff, Arizona 86001
?
mi
from
Flagstaff, AZ
Click here to add this to my saved trials
Fort Worth, Texas 76104
?
mi
from
Fort Worth, TX
Click here to add this to my saved trials
Fridley, Minnesota 55432
?
mi
from
Fridley, MN
Click here to add this to my saved trials
Fullerton, California 92835
?
mi
from
Fullerton, CA
Click here to add this to my saved trials
Gainesville, Virginia 20155
?
mi
from
Gainesville, VA
Click here to add this to my saved trials
Garland, Texas 75042
?
mi
from
Garland, TX
Click here to add this to my saved trials
Gig Harbor, Washington 98332
?
mi
from
Gig Harbor, WA
Click here to add this to my saved trials
Gilbert, Arizona 85234
?
mi
from
Gilbert, AZ
Click here to add this to my saved trials
Glenview, Illinois 60025
?
mi
from
Glenview, IL
Click here to add this to my saved trials
Goshen, Indiana 46526
?
mi
from
Goshen, IN
Click here to add this to my saved trials
Grapevine, Texas 76051
?
mi
from
Grapevine, TX
Click here to add this to my saved trials
Greensboro, North Carolina 27401
?
mi
from
Greensboro, NC
Click here to add this to my saved trials
Halifax, Nova Scotia
?
mi
from
Halifax,
Click here to add this to my saved trials
Hampton, Virginia 23666
?
mi
from
Hampton, VA
Click here to add this to my saved trials
Henderson, Nevada 89014
?
mi
from
Henderson, NV
Click here to add this to my saved trials
Highland Park, Illinois 60035
?
mi
from
Highland Park, IL
Click here to add this to my saved trials
Hollywood, Florida 33021
?
mi
from
Hollywood, FL
Click here to add this to my saved trials
Houston, Texas 77030
?
mi
from
Houston, TX
Click here to add this to my saved trials
Hudson, Florida 34667
?
mi
from
Hudson, FL
Click here to add this to my saved trials
Jefferson City, Missouri 65109
?
mi
from
Jefferson City, MO
Click here to add this to my saved trials
Joliet, Illinois 60435
?
mi
from
Joliet, IL
Click here to add this to my saved trials
Kerrville, Texas 78028
?
mi
from
Kerrville, TX
Click here to add this to my saved trials
La Jolla, California 92037
?
mi
from
La Jolla, CA
Click here to add this to my saved trials
Lakewood, Washington 98499
?
mi
from
Lakewood, WA
Click here to add this to my saved trials
Las Vegas, Nevada 89135
?
mi
from
Las Vegas, NV
Click here to add this to my saved trials
Layton, Utah 84041
?
mi
from
Layton, UT
Click here to add this to my saved trials
Leesburg, Virginia 20176
?
mi
from
Leesburg, VA
Click here to add this to my saved trials
Long Beach, California 90813
?
mi
from
Long Beach, CA
Click here to add this to my saved trials
Los Angeles, California 90095
?
mi
from
Los Angeles, CA
Click here to add this to my saved trials
Maplewood, Minnesota 55109
?
mi
from
Maplewood, MN
Click here to add this to my saved trials
Mesa, Arizona 85205
?
mi
from
Mesa, AZ
Click here to add this to my saved trials
Minneapolis, Minnesota 55402
?
mi
from
Minneapolis, MN
Click here to add this to my saved trials
Mishawaka, Indiana 46545
?
mi
from
Mishawaka, IN
Click here to add this to my saved trials
Murray, Utah 84107
?
mi
from
Murray, UT
Click here to add this to my saved trials
New Port Richey, Florida 34653
?
mi
from
New Port Richey, FL
Click here to add this to my saved trials
Newport News, Virginia 23606
?
mi
from
Newport News, VA
Click here to add this to my saved trials
Niles, Illinois 60714
?
mi
from
Niles, IL
Click here to add this to my saved trials
Norfolk, Virginia 23507
?
mi
from
Norfolk, VA
Click here to add this to my saved trials
Odessa, Texas 79761
?
mi
from
Odessa, TX
Click here to add this to my saved trials
Peoria, Illinois 61615
?
mi
from
Peoria, IL
Click here to add this to my saved trials
Philadelphia, Pennsylvania 19102
?
mi
from
Philadelphia, PA
Click here to add this to my saved trials
Plano, Texas 75024
?
mi
from
Plano, TX
Click here to add this to my saved trials
Provo, Utah 84604
?
mi
from
Provo, UT
Click here to add this to my saved trials
Puyallup, Washington 98372
?
mi
from
Puyallup, WA
Click here to add this to my saved trials
Radnor, Pennsylvania 19087
?
mi
from
Radnor, PA
Click here to add this to my saved trials
Raleigh, North Carolina 27609
?
mi
from
Raleigh, NC
Click here to add this to my saved trials
Saint Paul, Minnesota 55102
?
mi
from
Saint Paul, MN
Click here to add this to my saved trials
Salt Lake City, Utah 84103
?
mi
from
Salt Lake City, UT
Click here to add this to my saved trials
San Antonio, Texas 78207
Novartis Novartis, which was created in 1996 by the merger of the Swiss companies Ciba-Geigy...
?
mi
from
San Antonio, TX
Click here to add this to my saved trials
San Diego, California 92123
?
mi
from
San Diego, CA
Click here to add this to my saved trials
San Pablo, California 94806
?
mi
from
San Pablo, CA
Click here to add this to my saved trials
Sandy, Utah 84094
?
mi
from
Sandy, UT
Click here to add this to my saved trials
Santa Maria, California 93454
?
mi
from
Santa Maria, CA
Click here to add this to my saved trials
Seattle, Washington 98103
?
mi
from
Seattle, WA
Click here to add this to my saved trials
Sedona, Arizona 86336
?
mi
from
Sedona, AZ
Click here to add this to my saved trials
Silver Spring, Maryland 20901
?
mi
from
Silver Spring, MD
Click here to add this to my saved trials
Skokie, Illinois 60077
?
mi
from
Skokie, IL
Click here to add this to my saved trials
Tacoma, Washington 98405
?
mi
from
Tacoma, WA
Click here to add this to my saved trials
Tucson, Arizona 85745
?
mi
from
Tucson, AZ
Click here to add this to my saved trials
Virginia Beach, Virginia 23456
?
mi
from
Virginia Beach, VA
Click here to add this to my saved trials
Washington, North Carolina 27889
?
mi
from
Washington, NC
Click here to add this to my saved trials
West Bloomfield, Michigan 48322
?
mi
from
West Bloomfield, MI
Click here to add this to my saved trials
Williamsburg, Virginia 23185
?
mi
from
Williamsburg, VA
Click here to add this to my saved trials
Winfield, Illinois 60190
?
mi
from
Winfield, IL
Click here to add this to my saved trials
Woodbury, Minnesota 55125
?
mi
from
Woodbury, MN
Click here to add this to my saved trials