Home > Expanded Access > EAP (Expanded Access Protocol) Of Lapatinib Combined With Capecitabine In Metastatic Breast Cancer

Novartis

EAP (Expanded Access Protocol) Of Lapatinib Combined With Capecitabine In Metastatic Breast Cancer

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: 

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Huntsville, Alabama, 35805

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Anchorage, Alaska, 99508

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Glendale, Arizona, 85304

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Fayetteville, Arkansas, 72703

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Little Rock, Arkansas, 72205

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Bellflower, California, 90706

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Burbank, California, 91505-4866

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Gilroy, California, 95020

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Long Beach, California, 90806

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Long Beach, California, 90813

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Newport Beach, California, 92663

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San Diego, California, 92123

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San Francisco, California, 94115-1710

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Santa Rosa, California, 95403-1757

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Stockton, California, 95204

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Aurora, Colorado, 80010

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Boulder, Colorado, 80304

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Lafayette, Colorado, 80026

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Hartford, Connecticut, 06105

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Manchester, Connecticut, 06040

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New Havey, Connecticut, 06511

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Norwich, Connecticut, 06360

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Washington, District of Columbia, 20007

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Fort Lauderdale, Florida, 33328

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Fort Myers, Florida, 33916

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Fort Walton Beach, Florida, 32547

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Gainesville, Florida, 32605

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Hollywood, Florida, 33021

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Jacksonville, Florida, 32256

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Miami, Florida, 33133

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Orlando, Florida, 32804

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Orlando, Florida, 32806

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Tampa, Florida, 33607

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Augusta, Georgia, 30901

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Brunswick, Georgia, 31525

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Macon, Georgia, 31201

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Marietta, Georgia, 30060

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Tucker, Georgia, 30084

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Honolulu, Hawaii, 96813

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Boise, Idaho, 83712

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Chicago, Illinois, 60637

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Decatur, Illinois, 62526

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Galesburg, Illinois, 61401

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Highland Park, Illinois, 60035

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Joliet, Illinois, 60435

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Peoria, Illinois, 61615

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Zion, Illinois, 60099

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Indianapolis, Indiana, 46202

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Bettendorf, Iowa, 52722

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Cedar Rapids, Iowa, 52403

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Council Bluffs, Iowa, 51503

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Sioux City, Iowa, 51101-1733

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Waterloo, Iowa, 50702

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Baton Rouge, Louisiana, 70809

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Metairie, Louisiana, 70006

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Portland, Maine, 04101

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Scarborough, Maine, 04074

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Waterville, Maine, 04901

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Baltimore, Maryland, 21231-1000

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Baltimore, Maryland, 21237

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Chevy Chase, Maryland, 20815

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Frederick, Maryland, 21701

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Boston, Massachusetts, 02111

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Boston, Massachusetts, 02118

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Fall River, Massachusetts, 02721

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Peabody, Massachusetts, 01960

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Ann Arbor, Michigan, 48106

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Detroit, Michigan, 48202

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Royal Oak, Michigan, 48073

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Troy, Michigan, 48085

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Duluth, Minnesota, 55802

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Jackson, Mississippi, 39202

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Columbia, Missouri, 65201

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Kalamazoo, Missouri, 49007

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Kansas City, Missouri, 64118

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Springfield, Missouri, 65807

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St. Louis, Missouri, 63110

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St. Louis, Missouri, 63141

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Billings, Montana, 59101

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Great Falls, Montana, 59405

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Grand Island, Nebraska, 68803

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Lincoln, Nebraska, 68510

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North Platte, Nebraska, 69103

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Omaha, Nebraska, 68114

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Omaha, Nebraska, 68124-2346

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Las Vegas, Nevada, 89102

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Exeter, New Hampshire, 03833

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Flemington, New Jersey, 08822

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Freehold, New Jersey, 07728

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Little Silver, New Jersey, 07739

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Livingston, New Jersey, 07039

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Mountain Lakes, New Jersey, 07046

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Newark, New Jersey, 07112

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Buffalo, New York, 14221

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Buffalo, New York, 14263

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East Setauket, New York, 11733

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East Syracuse, New York, 13057

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Fresh Meadows, New York, 11366

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Glens Falls, New York, 12801

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New York, New York, 10003

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New York, New York, 10011

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New York, New York, 10016

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New York, New York, 10065

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Asheville, North Carolina, 28816

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Charlotte, North Carolina, 28203

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Charlotte, North Carolina, 28204

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Fayetteville, North Carolina, 28304

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Greensboro, North Carolina, 27403

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Bismarck, North Dakota, 58501

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Fargo, North Dakota, 58122

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Cincinnati, Ohio, 45219

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Cincinnati, Ohio, 45242

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Cleveland, Ohio, 44106

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Columbus, Ohio, 39705

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Columbus, Ohio, 43210

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Sandusky, Ohio, 44870

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Oklahoma City, Oklahoma, 73109

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Tulsa, Oklahoma, 74104

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Tulsa, Oklahoma, 74133

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Klamath Falls, Oregon, 97601

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Portland, Oregon, 97213

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Drexel Hill, Pennsylvania, 19026

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Philadelphia, Pennsylvania, 19104

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Philadelphia, Pennsylvania, 19106

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Philadelphia, Pennsylvania, 19111

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Pittsburgh, Pennsylvania, 15212-4772

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Pittsburgh, Pennsylvania, 15213

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Pottstown, Pennsylvania, 19464

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Sayre, Pennsylvania, 18840

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State College, Pennsylvania, 16803

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Charleston, South Carolina, 29403

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Columbia, South Carolina, 29210

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Florence, South Carolina, 29506

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Mt. Pleasant, South Carolina, 29464

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Knoxville, Tennessee, 37916

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Memphis, Tennessee, 38120

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Nashville, Tennessee, 37203

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Arlington, Texas, 76012

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Austin, Texas, 78731

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Austin, Texas, 78759

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Dallas, Texas, 75230

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Dallas, Texas, 75246

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El Paso, Texas, 79912

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Houston, Texas, 77030

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Houston, Texas, 77230-1439

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San Antonio, Texas, 78207

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Salt Lake City, Utah, 84112-5550

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Fairfax, Virginia, 22031

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Richmond, Virginia, 23230

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Richmond, Virginia, 23294

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Kennewick, Washington, 99336

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Mount Vernon, Washington, 98273

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Seattle, Washington, 98112

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Tacoma, Washington, 98405

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Walla Walla, Washington, 99362

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Morgantown, West Virginia, 26506

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Green Bay, Wisconsin, 54311

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La Crosse, Wisconsin, 54601

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Marshfield, Wisconsin, 54449

Novartis Pharmaceuticals
Study Director
Novartis Pharmaceuticals

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