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Phase II Study of Capecitabine in Combination With Vinorelbine and Trastuzumab for the First- or Second-LineTreatment of HER2+ Metastatic Breast Cancer

Phase 2
18 Years
Not Enrolling
Breast Cancer

Thank you

Trial Information

Phase II Study of Capecitabine in Combination With Vinorelbine and Trastuzumab for the First- or Second-LineTreatment of HER2+ Metastatic Breast Cancer



- Determine the overall response rate in patients with HER2/neu-overexpressing metastatic
breast cancer treated with first- or second-line therapy comprising capecitabine,
vinorelbine, and trastuzumab (Herceptin^®).


- Determine the time to disease progression, duration of response, and overall survival
of patients treated with this regimen.

- Determine the safety profile of this regimen in these patients.

OUTLINE: This is a multicenter study.

Patients receive oral capecitabine twice daily on days 1-14, vinorelbine IV over 6-10
minutes on days 1 and 8, and trastuzumab (Herceptin^®) IV over 30-90 minutes on day 1.
Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.

Patients are followed every 3 months until disease progression and then every 6 months for
up to 5 years.

PROJECTED ACCRUAL: A total of 5-47 patients will be accrued for this study within 23 months.

Inclusion Criteria


- Histologically or cytologically confirmed invasive breast cancer

- Metastatic disease

- HER2/neu-positive by immunohistochemistry (3+ by HercepTest^™ or equivalent) OR
positive for amplification by fluorescent in situ hybridization

- Testing may be performed in the primary tumor or the metastatic site

- Received prior anthracycline or taxane as adjuvant therapy or for metastatic disease

- Measurable disease

- At least one measurable lesion ≥ 2.0 cm by CT scan or MRI OR ≥ 1.0 cm by spiral
CT scan

- The following are considered non-measurable disease:

- Bone lesions

- Leptomeningeal disease

- Ascites

- Pleural/pericardial effusion

- Inflammatory breast disease

- Lymphangitis cutis/pulmonis

- Abdominal masses that are not confirmed and followed by imaging techniques

- Cystic lesions

- No bone metastases as the only evidence of metastasis

- Previously treated CNS metastases allowed provided disease has been stable for ≥ the
past 3 months

- Hormone receptor status:

- Not specified



- 18 and over


- Female or male

Menopausal status

- Not specified

Performance status

- ECOG 0-2

Life expectancy

- At least 12 weeks


- Absolute neutrophil count ≥ 1,500/mm^3

- Hemoglobin ≥ 8.0 g/dL

- Platelet count ≥ 100,000/mm^3

- No known uncontrolled coagulopathy


- Bilirubin ≤ 3.0 times the upper limit of normal (ULN)

- One of the following must be true:

- AST or ALT ≤ 5 times ULN AND alkaline phosphatase normal

- Alkaline phosphatase ≤ 5 times ULN AND AST or ALT normal

- Alkaline phosphatase ≤ 2.5 times ULN AND AST or ALT ≤ 1.5 times ULN

- INR ≤ 1.5 times ULN


- Calcium ≤ 11.5 mg/dL

- Creatinine ≤ 1.5 times ULN

- Creatinine clearance ≥ 30 mL/min


- LVEF ≥ 50% by MUGA or echocardiogram

- No clinically significant (i.e., active) cardiac disease

- No congestive heart failure

- No symptomatic coronary artery disease

- No myocardial infarction within the past 12 months

- No cardiac arrhythmia not controlled with medication


- Able to take oral medication

- No lack of physical integrity of the upper gastrointestinal tract

- No clinically significant malabsorption syndrome


- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective contraception during and for 30 days after study

- No history of allergy or hypersensitivity to study drugs, drug product excipients,
including polysorbate 80, or chemically similar agents

- No prior unanticipated severe reaction to fluoropyrimidine therapy

- No know hypersensitivity to fluorouracil

- No known dihydropyrimidine dehydrogenase deficiency

- No history of uncontrolled seizures or CNS disorders

- No clinically significant psychiatric disability that would preclude giving informed
consent or study compliance

- No other serious uncontrolled infection or disease

- No other malignancy within the past 5 years except cured basal cell skin cancer,
carcinoma in situ of the cervix, or contralateral breast cancer


Biologic therapy

- Prior adjuvant trastuzumab (Herceptin^®) allowed as adjuvant or first-line therapy
for metastatic disease

- No concurrent immunotherapy


- See Disease Characteristics

- No more than 1 prior chemotherapy regimen in the advanced or metastatic
(non-adjuvant) setting

- No prior continuous (≥ 24 hours) fluorouracil infusion

- No prior capecitabine

- No prior oral fluoropyrimidines (e.g., eniluracil and fluorouracil, uracil and
tegafur, S1, or emitefur)

Endocrine therapy

- At least 1 day since prior hormonal therapy

- No concurrent hormonal therapy


- More than 4 weeks since prior radiotherapy to the axial skeleton (i.e., skull, spinal
column, sternum, or ribs)

- No concurrent radiotherapy


- More than 4 weeks since prior major surgery

- No prior organ allografts requiring immunosuppressive therapy


- More than 4 weeks since prior investigational drugs

- No concurrent sorivudine or its chemically related analogues (e.g., brivudine)

- No concurrent allopurinol, metronidazole, or cimetidine

- No other concurrent cytotoxic agents

- No other concurrent investigational drugs

- No other concurrent anticancer therapy

Type of Study:


Study Design:

Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Overall response rate as measured by RECIST criteria

Safety Issue:


Principal Investigator

Winston Tan, MD, FACP

Investigator Role:

Study Chair

Investigator Affiliation:

Mayo Clinic


United States: Federal Government

Study ID:




Start Date:

August 2004

Completion Date:

Related Keywords:

  • Breast Cancer
  • recurrent breast cancer
  • stage IV breast cancer
  • male breast cancer
  • Breast Neoplasms



Mayo Clinic Scottsdale Scottsdale, Arizona  85259
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CCOP - Metro-Minnesota Saint Louis Park, Minnesota  55416
Rush-Copley Cancer Care Center Aurora, Illinois  60507
Joliet Oncology-Hematology Associates, Limited - West Joliet, Illinois  60435
Carle Cancer Center at Carle Foundation Hospital Urbana, Illinois  61801
Saint Anthony Memorial Health Centers Michigan City, Indiana  46360
Cedar Rapids Oncology Associates Cedar Rapids, Iowa  52403
Mercy Medical Center - Sioux City Sioux City, Iowa  51104
Siouxland Hematology-Oncology Associates, LLP Sioux City, Iowa  51101
St. Luke's Regional Medical Center Sioux City, Iowa  51104
CCOP - Michigan Cancer Research Consortium Ann Arbor, Michigan  48106
Saint Joseph Mercy Cancer Center Ann Arbor, Michigan  48106-0995
Oakwood Cancer Center at Oakwood Hospital and Medical Center Dearborn, Michigan  48123-2500
Genesys Hurley Cancer Institute Flint, Michigan  48503
Van Elslander Cancer Center at St. John Hospital and Medical Center Grosse Pointe Woods, Michigan  48236
Sparrow Regional Cancer Center Lansing, Michigan  48912-1811
St. John Macomb Hospital Warren, Michigan  48093
MeritCare Bemidji Bemidji, Minnesota  56601
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Mercy and Unity Cancer Center at Mercy Hospital Coon Rapids, Minnesota  55433
Duluth Clinic Cancer Center - Duluth Duluth, Minnesota  55805-1983
CCOP - Duluth Duluth, Minnesota  55805
Miller - Dwan Medical Center Duluth, Minnesota  55805
Fairview Southdale Hospital Edina, Minnesota  55435
Mercy and Unity Cancer Center at Unity Hospital Fridley, Minnesota  55432
Hutchinson Area Health Care Hutchinson, Minnesota  55350
Meeker County Memorial Hospital Lichfield, Minnesota  55355
Minnesota Oncology Hematology, PA - Maplewood Maplewood, Minnesota  55109
HealthEast Cancer Care at St. John's Hospital Maplewood, Minnesota  55109
Hennepin County Medical Center - Minneapolis Minneapolis, Minnesota  55415
Virginia Piper Cancer Institute at Abbott - Northwestern Hospital Minneapolis, Minnesota  55407
Hubert H. Humphrey Cancer Center at North Memorial Outpatient Center Robbinsdale, Minnesota  55422-2900
St. Francis Cancer Center at St. Francis Medical Center Shakopee, Minnesota  55379
HealthEast Cancer Care at St. Joseph's Hospital St Paul, Minnesota  55102
Park Nicollet Cancer Center St. Louis Park, Minnesota  55416
Regions Hospital Cancer Care Center St. Paul, Minnesota  55101
United Hospital St. Paul, Minnesota  55102
Ridgeview Medical Center Waconia, Minnesota  55387
Minnesota Oncology Hematology, PA - Woodbury Woodbury, Minnesota  55125
HealthEast Cancer Care at Woodwinds Health Campus Woodbury, Minnesota  55125
MeritCare Broadway Fargo, North Dakota  58122
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Geisinger Medical Group - Scenery Park State College, Pennsylvania  16801
Frank M. and Dorothea Henry Cancer Center at Geisinger Wyoming Valley Medical Center Wilkes-Barre, Pennsylvania  18711
Sanford Cancer Center at Sanford USD Medical Center Sioux Falls, South Dakota  57117-5039
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Avera Cancer Institute Sioux Falls, South Dakota  57105
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Methodist Medical Center of Illinois Peoria, Illinois  61636
Memorial Hospital of South Bend South Bend, Indiana  46601
Hinsdale, Illinois  60521
CCOP - Northern Indiana CR Consortium South Bend, Indiana  46601
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John Stoddard Cancer Center at Iowa Methodist Medical Center Des Moines, Iowa  50309
St. Vincent Mercy Medical Center Toledo, Ohio  43608
CCOP - Toledo Community Hospital Toledo, Ohio  43623-3456
Medical University of Ohio Cancer Center Toledo, Ohio  43614
Toledo Hospital Toledo, Ohio  43606
St. Vincent Hospital Regional Cancer Center Green Bay, Wisconsin  54307-3508
McCreery Cancer Center at Ottumwa Regional Ottumwa, Iowa  52501
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St. Mary's Hospital Medical Center - Green Bay Green Bay, Wisconsin  54303
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Bay Area Cancer Care Center at Bay Area Medical Center Marinette, Wisconsin  54143
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Graham Hospital Canton, Illinois  61520
Memorial Hospital Carthage, Illinois  62321
Eureka Community Hospital Eureka, Illinois  61530
Galesburg Cottage Hospital Galesburg, Illinois  61401
Mason District Hospital Havana, Illinois  62644
Hopedale Medical Complex Hopedale, Illinois  61747
McDonough District Hospital Macomb, Illinois  61455
BroMenn Regional Medical Center Normal, Illinois  61761
Community Cancer Center Normal, Illinois  61761
Community Hospital of Ottawa Ottawa, Illinois  61350
Oncology Hematology Associates of Central Illinois, PC - Ottawa Ottawa, Illinois  61350
Cancer Treatment Center at Pekin Hospital Pekin, Illinois  61554
Oncology Hematology Associates of Central Illinois, PC - Peoria Peoria, Illinois  61615
OSF St. Francis Medical Center Peoria, Illinois  61637
Proctor Hospital Peoria, Illinois  61614
Illinois Valley Community Hospital Peru, Illinois  61354
Perry Memorial Hospital Princeton, Illinois  61356
St. Margaret's Hospital Spring Valley, Illinois  61362
Center for Cancer Therapy at LaPorte Hospital and Health Services La Porte, Indiana  46350
Bettendorf, Iowa  52722
John Stoddard Cancer Center at Iowa Lutheran Hospital Des Moines, Iowa  50316-2301
Mercy Capitol Hospital Des Moines, Iowa  50307
Medical Oncology and Hematology Associates at John Stoddard Cancer Center Des Moines, Iowa  50309
Medical Oncology and Hematology Associates at Mercy Cancer Center Des Moines, Iowa  50314
Mercy Cancer Center at Mercy Medical Center - Des Moines Des Moines, Iowa  50314
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Community Cancer Center of Monroe Monroe, Michigan  48162
Alexandria, Minnesota  56308
Coborn Cancer Center Saint Cloud, Minnesota  56303
CentraCare Clinic - River Campus St. Cloud, Minnesota  56303
Immanuel Medical Center Omaha, Nebraska  68122
Creighton University Medical Center Omaha, Nebraska  68131-2197
Bismarck Cancer Center Bismarck, North Dakota  58501
Wood County Oncology Center Bowling Green, Ohio  43402
Lima Memorial Hospital Lima, Ohio  45804
St. Luke's Hospital Maumee, Ohio  43537
Northwest Ohio Oncology Center Maumee, Ohio  43537
Toledo Clinic - Oregon Oregon, Ohio  43616
St. Charles Mercy Hospital Oregon, Ohio  43616
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Firelands Regional Medical Center Sandusky, Ohio  44870
Mercy Hospital of Tiffin Tiffin, Ohio  44883
Toledo Clinic, Incorporated - Main Clinic Toledo, Ohio  43623
Fulton County Health Center Wauseon, Ohio  43567
Mercy Cancer Center at Mercy Medical Center - North Iowa Mason City, Iowa  50401
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McFarland Clinic, PC Ames, Iowa  50010
Foote Memorial Hospital Jackson, Michigan  49201
Haematology-Oncology Associates of Ohio and Michigan, PC Lambertville, Michigan  48144
St. Mary Mercy Hospital Livonia, Michigan  48154
Mercy Memorial Hospital - Monroe Monroe, Michigan  48162
St. Joseph Mercy Oakland Pontiac, Michigan  48341-2985
Mercy Regional Cancer Center at Mercy Hospital Port Huron, Michigan  48060
Seton Cancer Institute at Saint Mary's - Saginaw Saginaw, Michigan  48601
Alegant Health Cancer Center at Bergan Mercy Medical Center Omaha, Nebraska  68124
Flower Hospital Cancer Center Sylvania, Ohio  43560
Fredericksburg Oncology, Incorporated Fredericksburg, Virginia  22401
Mid Dakota Clinic, PC Bismarck, North Dakota  58501
Galesburg Clinic, PC Galesburg, Illinois  61401
Trinity Cancer Center at Trinity Medical Center - 7th Street Campus Moline, Illinois  61265
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Medcenter One Hospital Cancer Care Center Bismarck, North Dakota  58501
St. Alexius Medical Center Cancer Center Bismarck, North Dakota  58502