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A Phase 2 Study of the Efficacy and Safety of Apricoxib in Combination With Lapatinib and Capecitabine in the Treatment of Patients With HER2/Neu+ Breast Cancer Who Have Failed Trastuzumab and Chemotherapy Including a Taxane

Phase 2
18 Years
Not Enrolling
Breast Cancer

Thank you

Trial Information

A Phase 2 Study of the Efficacy and Safety of Apricoxib in Combination With Lapatinib and Capecitabine in the Treatment of Patients With HER2/Neu+ Breast Cancer Who Have Failed Trastuzumab and Chemotherapy Including a Taxane

Inclusion Criteria:

- Females with pathologically determined locally advanced or metastatic human epidermal
growth factor receptor 2 positive (HER2/neu+) breast cancer

- Have progressed after treatment with chemotherapy including a taxane and trastuzumab

- Must have measurable disease by RECIST

- ECOG PS of 0,1, or 2

- MUGA scan or echocardiogram results show left ventricular ejection fraction greater
than or equal to 50%

Exclusion Criteria:

- Radiation therapy within 2 weeks, chemotherapy within 3 weeks, or noncytoxic
investigational agents within 4 weeks of initiating study treatment

- Evidence of New York Heart Association class III or greater cardiac disease

- History of MI, stroke, ventricular arrhythmia, or symptomatic conduction abnormality

- History of congenital QT prolongation

- Concurrent severe or uncontrolled medical disease

- Symptomatic central nervous system metastases

- Pregnant or nursing women

- Hypersensitivity or intolerance to apricoxib, lapatinib, capecitabine, 5-FU,
sulfonamides, aspirin, or NSAIDs

- Severe renal insufficiency

- History of upper GI bleeding, ulceration, or perforation- Concurrent use of potent
CYP3A4 inhibitors and CYP3A4 inducers

- Prior treatment with capecitabine

- Patients on anti-arrhythmic treatment

- Prior lapatinib therapy

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Outcome Measure:

To determine the anti-tumor activity of the combination of apricoxib/lapatinib-capecitabine compared with placebo/lapatinib-capecitabine as measured by time to disease progression.

Outcome Time Frame:

Time to disease progression

Safety Issue:


Principal Investigator

Sara Zaknoen, M.D.

Investigator Role:

Study Director

Investigator Affiliation:

Tragara Pharmaceuticals, Inc.


United States: Food and Drug Administration

Study ID:




Start Date:

April 2008

Completion Date:

September 2009

Related Keywords:

  • Breast Cancer
  • HER2/neu positive
  • locally advanced or metastatic
  • Breast Neoplasms



University of Texas Medical Branch Galveston, Texas  77555-1329
Madigan Army Medical Center Tacoma, Washington  98431-5048
Warren Hospital Phillipsburg, New Jersey  08865
Hematology Oncology Associates Atlantis, Florida  33462
Front Range Cancer Specialists Fort Collins, Colorado  80528
Mercy Hospital Port Huron, Michigan  48060
Alta Bates Summit Comprehensive Cancer Center Berkeley, California  94704
St. Mary Mercy Hospital Livonia, Michigan  48154
Flower Hospital Cancer Center Sylvania, Ohio  43560
Comprehensive Blood and Cancer Center Bakersfield, California  93309
Community Cancer Center at Rutland Regional Medical Center Rutland, Vermont  05701
Arizona Clinical Research Center Tucson, Arizona  85712
Baptist Regional Cancer Center Knoxville, Tennessee  37920
Providence Portland Medical Center Portland, Oregon  97213-3635
UCLA Los Angeles, California  90095
Bay Area Cancer Research Group, LLC Concord, California  94520
San Juan Oncology Associates Farmington, New Mexico  87401
Peninsula Cancer Institute Newport News, Virginia  23601
Suburban Hematology-Oncology Associates Lawrenceville, Georgia  30045
Penn State Milton S Hershey Medical Center Hershey, Pennsylvania  17033
University of Toledo Toledo, Ohio  43614
The Methodist Hospital Research Institute Houston, Texas  77030
Central Coast Medical Oncology Corporation Santa Maria, California  93454
Wilshire Oncology Medical Group Inc Laverne, California  91750
St. Jude Heritage Healthcare Fullerton, California  92835
Olive View- UCLA Medical Center Sylmar, California  91342
Cancer Care Associates Medical Group Inc Redondo Beach, California  
North America Research Institute San Dimas, California  
MD Anderson Cancer Center in Orlando Orlando, Florida  
Warren Billhartz Cancer Center Maryville, Illinois  
Mid-Illinois Hematology Oncology Associates Normal, Illinois  
Medical Consultants PC Muncie, Indiana  
SJMH Cancer Center Ann Arbor, Michigan  
Genesys Hurley Cancer Center Institute Flint, Michigan  
Foote Health System Jackson County, Michigan  
Bresline Cancer Center at Michigan State University Lansing, Michigan  
St. Mary's of Michigan Saginaw, Michigan  
St. Francis Cancer Treatment Center Grand Island, Nebraska  
Samaritan Hematology and Oncology Consulting Corvallis, Oregon  
Eastern Regional Medical Center Philadelphia, Pennsylvania  
Associates in Hematology-Oncology PC Upland, Pennsylvania  
Charleston Oncology Hematology Associates Charleston, South Carolina  
Jabboury Foundation for Cancer Research Inc Houston, Texas  
Fletcher Allen Healthcare Inc. Burlington, Vermont