Official Title
An Open-Label Expanded Access Study of Lapatinib and Capecitabine Therapy in Subjects With ErbB2 Overexpressing Locally Advanced or Metastatic Breast Cancer
Brief Summary

This study will provide pre-approval drug access to lapatinib, in combination with capecitabine, to patients whose breast cancer had progressed on other therapies

Approved for marketing
Neoplasms, Breast

Drug: lapatinib + capecitabine
Experimental

Eligibility Criteria

Inclusion criteria:

- May have received prior lapatinib in another trial. Previous capecitabine (as previous agent or non-lapatinib containing regimen) is also permitted.

- Prior treatment with hormonal therapy is allowed.

- Must have advanced or metastatic breast cancer with progression (as assessed by modified RECIST) after prior therapy, which must include all of the following: prior treatment with an anthracycline, a taxane, and trastuzumab alone or in combination with other therapy. Trastuzumab must have been administered in the adjuvant, or locally advanced or metastatic setting.

- Must have tumors that overexpress ErbB2 defined as +3 by IHC or FISH positive for ErbB2 gene amplification. The status of ErbB2 expression must be documented prior to study entry.

- Must be >/= 18 years of age

- Life expectancy of > 8 weeks

- Must have recovered from side effects of previous treatment

- Patients with CNS mets are eligible provided treatment with prohibited medications as listed in the protocol are not required

- Cardiac ejection fraction must be within the institutional range of normal as measured by ECHO. MUGA scans are allowed if ECHOs cannot be performed

- Able to swallow and retain oral medications

- Must have adequate hematologic, hepatic and renal function

Exclusion criteria:

- Pregnant or lactating females

- Malabsorption syndrome, disease significantly affecting GI function, or resection of the stomach or bowel, or ulcerative colitis

- Concurrent disease or condition that would make the patient inappropriate for study participation

- Unresolved or unstable toxicity from prior administration of another investigational drug and/or prior cancer treatment

- Uncontrolled infection

- Active cardiac disease defined as history of uncontrolled or symptomatic angina; history of arrhythmias requiring medication, or clinically significant, with the exception of asymptomatic atrial fibrillation requiring anticoagulation; MI < 6 months from study entry; uncontrolled or symptomatic CHF; ejection fraction below the institutional normal limit; any other cardiac condition that would make this protocol unreasonably hazardous for the patient

- Receiving concurrent chemotherapy (other than capecitabine), radiation therapy, immunotherapy, biologic therapy or hormonal therapy for cancer. Concurrent therapy with bisphosphonates is allowed

- History of allergic reaction attributed to compounds of similar composition to lapatinib or any excipients

- History of allergic reactions attributed to compounds of similar chemical composition to capecitabine, fluorouracil or excipients

- Known DPD deficiency

Eligibility Gender
All
Eligibility Age
Minimum: 18 Years
Countries
Australia
Austria
Belgium
Brazil
Bulgaria
Canada
Chile
China
Cyprus
Czech Republic
Denmark
Estonia
Finland
Germany
Greece
Hong Kong
Iceland
Indonesia
Ireland
Israel
Italy
Korea, Republic of
Luxembourg
Malaysia
Malta
Mexico
Netherlands
New Zealand
Peru
Philippines
Poland
Portugal
Romania
Russian Federation
Singapore
Slovakia
Slovenia
Spain
Sweden
Switzerland
Taiwan
Thailand
Ukraine
United Kingdom
United States
Locations

Novartis Investigative Site
Huntsville, Alabama, 35805

Novartis Investigative Site
Anchorage, Alaska, 99508

Novartis Investigative Site
Glendale, Arizona, 85304

Novartis Investigative Site
Fayetteville, Arkansas, 72703

Novartis Investigative Site
Little Rock, Arkansas, 72205

Novartis Investigative Site
Bellflower, California, 90706

Novartis Investigative Site
Burbank, California, 91505-4866

Novartis Investigative Site
Gilroy, California, 95020

Novartis Investigative Site
Long Beach, California, 90806

Novartis Investigative Site
Long Beach, California, 90813

Novartis Investigative Site
Newport Beach, California, 92663

Novartis Investigative Site
San Diego, California, 92123

Novartis Investigative Site
San Francisco, California, 94115-1710

Novartis Investigative Site
Santa Rosa, California, 95403-1757

Novartis Investigative Site
Stockton, California, 95204

Novartis Investigative Site
Aurora, Colorado, 80010

Novartis Investigative Site
Boulder, Colorado, 80304

Novartis Investigative Site
Lafayette, Colorado, 80026

Novartis Investigative Site
Hartford, Connecticut, 06105

Novartis Investigative Site
Manchester, Connecticut, 06040

Novartis Investigative Site
New Havey, Connecticut, 06511

Novartis Investigative Site
Norwich, Connecticut, 06360

Novartis Investigative Site
Washington, District of Columbia, 20007

Novartis Investigative Site
Fort Lauderdale, Florida, 33328

Novartis Investigative Site
Fort Myers, Florida, 33916

Novartis Investigative Site
Fort Walton Beach, Florida, 32547

Novartis Investigative Site
Gainesville, Florida, 32605

Novartis Investigative Site
Hollywood, Florida, 33021

Novartis Investigative Site
Jacksonville, Florida, 32256

Novartis Investigative Site
Miami, Florida, 33133

Novartis Investigative Site
Orlando, Florida, 32804

Novartis Investigative Site
Orlando, Florida, 32806

Novartis Investigative Site
Tampa, Florida, 33607

Novartis Investigative Site
Augusta, Georgia, 30901

Novartis Investigative Site
Brunswick, Georgia, 31525

Novartis Investigative Site
Macon, Georgia, 31201

Novartis Investigative Site
Marietta, Georgia, 30060

Novartis Investigative Site
Tucker, Georgia, 30084

Novartis Investigative Site
Honolulu, Hawaii, 96813

Novartis Investigative Site
Boise, Idaho, 83712

Novartis Investigative Site
Chicago, Illinois, 60637

Novartis Investigative Site
Decatur, Illinois, 62526

Novartis Investigative Site
Galesburg, Illinois, 61401

Novartis Investigative Site
Highland Park, Illinois, 60035

Novartis Investigative Site
Joliet, Illinois, 60435

Novartis Investigative Site
Peoria, Illinois, 61615

Novartis Investigative Site
Zion, Illinois, 60099

Novartis Investigative Site
Indianapolis, Indiana, 46202

Novartis Investigative Site
Bettendorf, Iowa, 52722

Novartis Investigative Site
Cedar Rapids, Iowa, 52403

Novartis Investigative Site
Council Bluffs, Iowa, 51503

Novartis Investigative Site
Sioux City, Iowa, 51101-1733

Novartis Investigative Site
Waterloo, Iowa, 50702

Novartis Investigative Site
Baton Rouge, Louisiana, 70809

Novartis Investigative Site
Metairie, Louisiana, 70006

Novartis Investigative Site
Portland, Maine, 04101

Novartis Investigative Site
Scarborough, Maine, 04074

Novartis Investigative Site
Waterville, Maine, 04901

Novartis Investigative Site
Baltimore, Maryland, 21231-1000

Novartis Investigative Site
Baltimore, Maryland, 21237

Novartis Investigative Site
Chevy Chase, Maryland, 20815

Novartis Investigative Site
Frederick, Maryland, 21701

Novartis Investigative Site
Boston, Massachusetts, 02111

Novartis Investigative Site
Boston, Massachusetts, 02118

Novartis Investigative Site
Fall River, Massachusetts, 02721

Novartis Investigative Site
Peabody, Massachusetts, 01960

Novartis Investigative Site
Ann Arbor, Michigan, 48106

Novartis Investigative Site
Detroit, Michigan, 48202

Novartis Investigative Site
Royal Oak, Michigan, 48073

Novartis Investigative Site
Troy, Michigan, 48085

Novartis Investigative Site
Duluth, Minnesota, 55802

Novartis Investigative Site
Jackson, Mississippi, 39202

Novartis Investigative Site
Columbia, Missouri, 65201

Novartis Investigative Site
Kalamazoo, Missouri, 49007

Novartis Investigative Site
Kansas City, Missouri, 64118

Novartis Investigative Site
Springfield, Missouri, 65807

Novartis Investigative Site
St. Louis, Missouri, 63110

Novartis Investigative Site
St. Louis, Missouri, 63141

Novartis Investigative Site
Billings, Montana, 59101

Novartis Investigative Site
Great Falls, Montana, 59405

Novartis Investigative Site
Grand Island, Nebraska, 68803

Novartis Investigative Site
Lincoln, Nebraska, 68510

Novartis Investigative Site
North Platte, Nebraska, 69103

Novartis Investigative Site
Omaha, Nebraska, 68114

Novartis Investigative Site
Omaha, Nebraska, 68124-2346

Novartis Investigative Site
Las Vegas, Nevada, 89102

Novartis Investigative Site
Exeter, New Hampshire, 03833

Novartis Investigative Site
Flemington, New Jersey, 08822

Novartis Investigative Site
Freehold, New Jersey, 07728

Novartis Investigative Site
Little Silver, New Jersey, 07739

Novartis Investigative Site
Livingston, New Jersey, 07039

Novartis Investigative Site
Mountain Lakes, New Jersey, 07046

Novartis Investigative Site
Newark, New Jersey, 07112

Novartis Investigative Site
Buffalo, New York, 14221

Novartis Investigative Site
Buffalo, New York, 14263

Novartis Investigative Site
East Setauket, New York, 11733

Novartis Investigative Site
East Syracuse, New York, 13057

Novartis Investigative Site
Fresh Meadows, New York, 11366

Novartis Investigative Site
Glens Falls, New York, 12801

Novartis Investigative Site
New York, New York, 10003

Novartis Investigative Site
New York, New York, 10011

Novartis Investigative Site
New York, New York, 10016

Novartis Investigative Site
New York, New York, 10065

Novartis Investigative Site
Asheville, North Carolina, 28816

Novartis Investigative Site
Charlotte, North Carolina, 28203

Novartis Investigative Site
Charlotte, North Carolina, 28204

Novartis Investigative Site
Fayetteville, North Carolina, 28304

Novartis Investigative Site
Greensboro, North Carolina, 27403

Novartis Investigative Site
Bismarck, North Dakota, 58501

Novartis Investigative Site
Fargo, North Dakota, 58122

Novartis Investigative Site
Cincinnati, Ohio, 45219

Novartis Investigative Site
Cincinnati, Ohio, 45242

Novartis Investigative Site
Cleveland, Ohio, 44106

Novartis Investigative Site
Columbus, Ohio, 39705

Novartis Investigative Site
Columbus, Ohio, 43210

Novartis Investigative Site
Sandusky, Ohio, 44870

Novartis Investigative Site
Oklahoma City, Oklahoma, 73109

Novartis Investigative Site
Tulsa, Oklahoma, 74104

Novartis Investigative Site
Tulsa, Oklahoma, 74133

Novartis Investigative Site
Klamath Falls, Oregon, 97601

Novartis Investigative Site
Portland, Oregon, 97213

Novartis Investigative Site
Drexel Hill, Pennsylvania, 19026

Novartis Investigative Site
Philadelphia, Pennsylvania, 19104

Novartis Investigative Site
Philadelphia, Pennsylvania, 19106

Novartis Investigative Site
Philadelphia, Pennsylvania, 19111

Novartis Investigative Site
Pittsburgh, Pennsylvania, 15212-4772

Novartis Investigative Site
Pittsburgh, Pennsylvania, 15213

Novartis Investigative Site
Pottstown, Pennsylvania, 19464

Novartis Investigative Site
Sayre, Pennsylvania, 18840

Novartis Investigative Site
State College, Pennsylvania, 16803

Novartis Investigative Site
Charleston, South Carolina, 29403

Novartis Investigative Site
Columbia, South Carolina, 29210

Novartis Investigative Site
Florence, South Carolina, 29506

Novartis Investigative Site
Mt. Pleasant, South Carolina, 29464

Novartis Investigative Site
Knoxville, Tennessee, 37916

Novartis Investigative Site
Memphis, Tennessee, 38120

Novartis Investigative Site
Nashville, Tennessee, 37203

Novartis Investigative Site
Arlington, Texas, 76012

Novartis Investigative Site
Austin, Texas, 78731

Novartis Investigative Site
Austin, Texas, 78759

Novartis Investigative Site
Dallas, Texas, 75230

Novartis Investigative Site
Dallas, Texas, 75246

Novartis Investigative Site
El Paso, Texas, 79912

Novartis Investigative Site
Houston, Texas, 77030

Novartis Investigative Site
Houston, Texas, 77230-1439

Novartis Investigative Site
San Antonio, Texas, 78207

Novartis Investigative Site
Salt Lake City, Utah, 84112-5550

Novartis Investigative Site
Fairfax, Virginia, 22031

Novartis Investigative Site
Richmond, Virginia, 23230

Novartis Investigative Site
Richmond, Virginia, 23294

Novartis Investigative Site
Kennewick, Washington, 99336

Novartis Investigative Site
Mount Vernon, Washington, 98273

Novartis Investigative Site
Seattle, Washington, 98112

Novartis Investigative Site
Tacoma, Washington, 98405

Novartis Investigative Site
Walla Walla, Washington, 99362

Novartis Investigative Site
Morgantown, West Virginia, 26506

Novartis Investigative Site
Green Bay, Wisconsin, 54311

Novartis Investigative Site
La Crosse, Wisconsin, 54601

Novartis Investigative Site
Marshfield, Wisconsin, 54449

Novartis Pharmaceuticals
Study Director
Novartis Pharmaceuticals

NCT Number
Keywords
advanced
TYKERB
HER2 positive
Stage IIIc
ErbB2 positive
GW572016
metastatic
Stage IIIb
breast cancer
MeSH Terms
Breast Neoplasms
Capecitabine
Lapatinib