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Trastuzumab, Ixabepilone, and Carboplatin in Treating Patients With HER2/Neu-Positive Metastatic Breast Cancer
This study is ongoing, but not recruiting participants.
First Received: February 10, 2004   Last Updated: February 6, 2009   History of Changes
Sponsor: Eastern Cooperative Oncology Group
Collaborators: National Cancer Institute (NCI)
North Central Cancer Treatment Group
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00077376
  Purpose

RATIONALE: Monoclonal antibodies, such as trastuzumab, can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. Drugs used in chemotherapy, such as ixabepilone and carboplatin, work in different ways to stop tumor cells from dividing so they stop growing or die. Combining trastuzumab with ixabepilone and carboplatin may kill more tumor cells.

PURPOSE: This phase II trial is studying how well giving trastuzumab together with ixabepilone and carboplatin works in treating patients with HER2/neu-positive metastatic breast cancer.


Condition Intervention Phase
Breast Cancer
Biological: trastuzumab
Drug: carboplatin
Drug: ixabepilone
Phase II

Study Type: Interventional
Study Design: Treatment, Open Label
Official Title: A Phase II Trial Of Trastuzumab Plus Weekly Ixabepilone (BMS-247550) And Carboplatin In Patients With HER/Neu-Positive Metastatic Breast Cancer

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Objective response rate (partial and complete response) [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Time to disease progression [ Designated as safety issue: No ]
  • Time to treatment failure [ Designated as safety issue: No ]
  • Overall survival [ Designated as safety issue: No ]
  • Toxicity [ Designated as safety issue: Yes ]

Study Start Date: March 2004
Detailed Description:

OBJECTIVES:

Primary

  • Determine the response rate in patients with HER2/neu-positive metastatic breast cancer treated with trastuzumab (Herceptin®), ixabepilone, and carboplatin.

Secondary

  • Determine the time to disease progression and time to treatment failure in patients treated with this regimen.
  • Determine the toxicity of this regimen in these patients.
  • Determine the overall survival of patients treated with this regimen.

OUTLINE: This is a multicenter study.

  • Induction therapy: Patients receive trastuzumab (Herceptin®) IV over 30 minutes* on days 1, 8, 15, and 22 and ixabepilone IV over 1 hour and carboplatin IV over 1 hour on days 1, 8, and 15. Treatment repeats every 28 days for up to 6 courses in the absence of unacceptable toxicity.

NOTE: *Trastuzumab is given over 90 minutes on day 1 of course 1 (induction therapy) only.

  • Maintenance therapy: Patients receive trastuzumab IV over 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 for 2 years and then every 6 months for 3 years from study entry.

PROJECTED ACCRUAL: A total of 10-60 patients will be accrued for this study within 1-6 months.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • Histologically confirmed adenocarcinoma of the breast

    • Metastatic disease
  • HER2/neu-positive (3+) disease by immunohistochemistry or fluorescent in situ hybridization
  • At least 1 objectively measurable disease parameter

    • No brain metastases as the only site of measurable disease
    • Previously irradiated tumors are not considered measurable disease, except for recurrent disease located in an area of prior adjuvant irradiation (e.g., axilla or chest wall)
  • No untreated brain metastases

    • Previously treated brain metastases that have responded to prior radiotherapy and/or surgery are allowed
  • Hormone receptor status:

    • Not specified

PATIENT CHARACTERISTICS:

Age

  • 18 and over

Sex

  • Male or female

Menopausal status

  • Not specified

Performance status

  • ECOG 0-1

Life expectancy

  • Not specified

Hematopoietic

  • Granulocyte count ≥ 1,500/mm^3
  • Platelet count ≥ 100,000/mm^3

Hepatic

  • AST and ALT ≤ 1.5 times upper limit of normal (ULN) (2.0 times ULN for patients with liver involvement by tumor)

Renal

  • Creatinine ≤ 1.5 mg/dL

Cardiovascular

  • LVEF within lower limit of normal by MUGA or echocardiogram
  • No New York Heart Association class III or IV heart disease

Other

  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective nonhormonal contraception
  • No prior severe (grade 3 or 4) hypersensitivity reaction to drugs formulated in polyoxyethylated castor oil (Cremophor EL)
  • No peripheral neuropathy
  • No other malignancy within the past 5 years except curatively treated basal cell or squamous cell skin cancer or carcinoma in situ of the cervix

PRIOR CONCURRENT THERAPY:

Biologic therapy

  • No prior trastuzumab (Herceptin®) for metastatic disease
  • No concurrent pegfilgrastim

Chemotherapy

  • No prior ixabepilone for metastatic disease
  • No prior carboplatin for metastatic disease
  • No other prior chemotherapy for metastatic disease
  • No prior cumulative doxorubicin dose > 360 mg/m^2
  • No prior cumulative epirubicin dose > 640 mg/m^2

Endocrine therapy

  • Prior hormonal therapy for metastatic disease allowed
  • At least 1 week since prior hormonal therapy
  • No concurrent hormonal therapy

Radiotherapy

  • See Disease Characteristics
  • At least 2 weeks since prior radiotherapy
  • No concurrent radiotherapy, including radiotherapy for brain metastases

Surgery

  • See Disease Characteristics
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00077376

  Hide Study Locations
Locations
United States, California
Memorial Medical Center Cancer Services
Modesto, California, United States, 95355
United States, Connecticut
Saint Francis/Mount Sinai Regional Cancer Center at Saint Francis Hospital and Medical Center
Hartford, Connecticut, United States, 06105
United States, Delaware
Beebe Medical Center
Lewes, Delaware, United States, 19958
CCOP - Christiana Care Health Services
Newark, Delaware, United States, 19713
St. Francis Hospital
Wilmington, Delaware, United States, 19805
United States, Florida
Baptist Cancer Institute - Jacksonville
Jacksonville, Florida, United States, 32207
H. Lee Moffitt Cancer Center and Research Institute at University of South Florida
Tampa, Florida, United States, 33612-9497
Mayo Clinic - Jacksonville
Jacksonville, Florida, United States, 32224
United States, Illinois
Alexian Brothers Radiation Oncology
Elk Grove Village, Illinois, United States, 60007
BroMenn Regional Medical Center
Normal, Illinois, United States, 61761
Cancer Treatment Center at Pekin Hospital
Pekin, Illinois, United States, 61554
Carle Cancer Center at Carle Foundation Hospital
Urbana, Illinois, United States, 61801
CCOP - Carle Cancer Center
Urbana, Illinois, United States, 61801
CCOP - Illinois Oncology Research Association
Peoria, Illinois, United States, 61615
Community Cancer Center
Normal, Illinois, United States, 61761
Community Hospital of Ottawa
Ottawa, Illinois, United States, 61350
Decatur Memorial Hospital Cancer Care Institute
Decatur, Illinois, United States, 62526
Eureka Community Hospital
Eureka, Illinois, United States, 61530
Galesburg Clinic
Galesburg, Illinois, United States, 61401
Galesburg Cottage Hospital
Galesburg, Illinois, United States, 61401
Graham Hospital
Canton, Illinois, United States, 61520
Hematology and Oncology Associates
Chicago, Illinois, United States, 60611
Hematology Oncology Associates - Skokie
Skokie, Illinois, United States, 60076
Hematology/Oncology of the North Shore at Gross Point Medical Center
Skokie, Illinois, United States, 60076
Hinsdale Hematology Oncology Associates
Hinsdale, Illinois, United States, 60521
St. Margaret's Hospital
Spring Valley, Illinois, United States, 61362
Illinois Valley Community Hospital
Peru, Illinois, United States, 61354
Ingalls Cancer Care Center at Ingalls Memorial Hospital
Harvey, Illinois, United States, 60426
Joliet Oncology Hematology Associates, Limited - West
Joliet, Illinois, United States, 60435
Kewanee Hospital
Kewanee, Illinois, United States, 61443
Mason District Hospital
Havana, Illinois, United States, 62644
McDonough District Hospital
Macomb, Illinois, United States, 61455
Memorial Hospital
Carthage, Illinois, United States, 62321
Mercy Hospital and Medical Center
Chicago, Illinois, United States, 60616
Methodist Medical Center of Illinois
Peoria, Illinois, United States, 61636
Midwest Cancer Research Group, Incorporated
Skokie, Illinois, United States, 60077
Midwest Center for Hematology/Oncology
Joliet, Illinois, United States, 60432
North Shore Oncology and Hematology Associates, Limited - Libertyville
Libertyville, Illinois, United States, 60048
Northwest Medical Specialist, PC
Niles, Illinois, United States, 60714
Oncology Hematology Associates of Central Illinois - Ottawa
Ottawa, Illinois, United States, 61350
Oncology/Hematology Associates of Central Illinois, P.C.
Peoria, Illinois, United States, 61615
OSF St. Francis Medical Center
Peoria, Illinois, United States, 61637
Perry Memorial Hospital
Princeton, Illinois, United States, 61356
Proctor Hospital
Peoria, Illinois, United States, 61614
Regional Cancer Center at Memorial Medical Center
Springfield, Illinois, United States, 62781
Robert H. Lurie Comprehensive Cancer Center at Northwestern University
Chicago, Illinois, United States, 60611-3013
Rush-Copley Cancer Care Center
Aurora, Illinois, United States, 60507
Saint James Hospital and Health Centers Comprehensive Cancer Institute - Olympia Fields
Olympia Fields, Illinois, United States, 60461
St. Joseph Medical Center
Bloomington, Illinois, United States, 61701
Hopedale Medical Complex
Hopedale, Illinois, United States, 61747
Swedish Covenant Hospital
Chicago, Illinois, United States, 60625
Veterans Affairs Medical Center - Lakeside Chicago
Chicago, Illinois, United States, 60611
United States, Indiana
CCOP - Northern Indiana CR Consortium
South Bend, Indiana, United States, 46601
Center for Cancer Therapy at LaPorte Hospital and Health Services
La Porte, Indiana, United States, 46350
Elkhart General Hospital
Elkhart, Indiana, United States, 46515
St. Francis Hospital and Health Centers - Beech Grove Campus
Beech Grove, Indiana, United States, 46107
Saint Anthony Memorial Health Centers
Michigan City, Indiana, United States, 46360
Saint Joseph Regional Medical Center
South Bend, Indiana, United States, 46617
Memorial Hospital of South Bend
South Bend, Indiana, United States, 46601
United States, Iowa
Burgess Health Center
Onawa, Iowa, United States, 51040
CCOP - Iowa Oncology Research Association
Des Moines, Iowa, United States, 50309
Cedar Rapids Oncology Associates
Cedar Rapids, Iowa, United States, 52403
John Stoddard Cancer Center at Iowa Lutheran Hospital
Des Moines, Iowa, United States, 50316-2301
St. Luke's Hospital
Cedar Rapids, Iowa, United States, 52402
McFarland Clinic, P. C.
Ames, Iowa, United States, 50010
Medical Oncology and Hematology Associates - West Des Moines
West Des Moines, Iowa, United States, 50266
Medical Oncology and Hematology Associates at John Stoddard Cancer Center
Des Moines, Iowa, United States, 50309
Medical Oncology and Hematology Associates at Mercy Cancer Center
Des Moines, Iowa, United States, 50314
Mercy Cancer Center at Mercy Medical Center - Des Moines
Des Moines, Iowa, United States, 50314
Mercy Cancer Center at Mercy Medical Center - North Iowa
Mason City, Iowa, United States, 50401
Mercy Capitol Hospital
Des Moines, Iowa, United States, 50307
Mercy Medical Center - Sioux City
Sioux City, Iowa, United States, 51104
Mercy Regional Cancer Center at Mercy Medical Center
Cedar Rapids, Iowa, United States, 52403
Siouxland Hematology-Oncology Associates at June E. Nylen Cancer Center
Sioux City, Iowa, United States, 51101
Siouxland Regional Cancer Center
Sioux City, Iowa, United States, 51101
John Stoddard Cancer Center at Iowa Methodist Medical Center
Des Moines, Iowa, United States, 50309
St. Luke's Regional Medical Center
Sioux City, Iowa, United States, 51104
United States, Louisiana
Baton Rouge General Regional Cancer Center
Baton Rouge, Louisiana, United States, 70806
CCOP - Ochsner
New Orleans, Louisiana, United States, 70121
Mary Bird Perkins Cancer Center - Baton Rouge
Baton Rouge, Louisiana, United States, 70809
Ochsner Cancer Institute at Ochsner Clinic Foundation
New Orleans, Louisiana, United States, 70121
Medical Center of Louisiana - New Orleans
New Orleans, Louisiana, United States, 70112
MBCCOP - LSU Health Sciences Center
New Orleans, Louisiana, United States, 70112
Ochsner Clinic of Baton Rouge
Baton Rouge, Louisiana, United States, 708169990
Terrebonne General Medical Center
Houma, Louisiana, United States, 70360
United States, Maryland
Union Hospital Cancer Center at Union Hospital
Elkton MD, Maryland, United States, 21921
United States, Massachusetts
Commonwealth Hematology-Oncology P. C. - Quincy
Quincy, Massachusetts, United States, 02169
Newton-Wellesley Hospital
Newton, Massachusetts, United States, 02462
Tufts - New England Medical Center
Boston, Massachusetts, United States, 02111
United States, Michigan
West Michigan Cancer Center
Kalamazoo, Michigan, United States, 49007-3731
Bronson Methodist Hospital
Kalamazoo, Michigan, United States, 49007
CCOP - Michigan Cancer Research Consortium
Ann Arbor, Michigan, United States, 48106
Genesys Hurley Cancer Institute
Flint, Michigan, United States, 48503
Green Bay Oncology, Limited - Escanaba
Escanaba, Michigan, United States, 49431
Green Bay Oncology, Limited - Iron Mountain
Iron Mountain, Michigan, United States, 49801
Lakeland Cancer Care Center at Lakeland Hospital - St. Joseph
St. Joseph, Michigan, United States, 49085
Seton Cancer Institute - Saginaw
Saginaw, Michigan, United States, 48601
St. John Macomb Hospital
Warren, Michigan, United States, 48093
St. Joseph Mercy Cancer Center at St. Joseph Mercy Hospital
Ann Arbor, Michigan, United States, 48106-0995
Van Elslander Cancer Center at St. John Hospital and Medical Center
Grosse Pointe Woods, Michigan, United States, 48236
Borgess Medical Center
Kalamazooaa, Michigan, United States, 49001
United States, Minnesota
Brainerd Medical Center
Brainerd, Minnesota, United States, 56401
CCOP - Duluth
Duluth, Minnesota, United States, 55805
CCOP - Metro-Minnesota
Saint Louis Park, Minnesota, United States, 55416
CentraCare Clinic - River Campus
St. Cloud, Minnesota, United States, 56303
Chippewa County - Montevideo Hospital
Montevideo, Minnesota, United States, 56265
Coborn Cancer Center
Saint Cloud, Minnesota, United States, 56303
Fairview Ridges Hospital
Burnsville, Minnesota, United States, 55337
Fairview Southdale Hospital
Edina, Minnesota, United States, 55435
HealthEast Cancer Care at St. John's Hospital
Maplewood, Minnesota, United States, 55109
Hennepin County Medical Center - Minneapolis
Minneapolis, Minnesota, United States, 55415
Hubert H. Humphrey Cancer Center at North Memorial Medical Center
Robbinsdale, Minnesota, United States, 55422-2900
Hutchinson Area Health Care
Hutchinson, Minnesota, United States, 55350
Mayo Clinic Cancer Center
Rochester, Minnesota, United States, 55905
Virginia Piper Cancer Institute at Abbott-Northwestern Hospital
Minneapolis, Minnesota, United States, 55407
Mercy and Unity Cancer Center at Unity Hospital
Fridley, Minnesota, United States, 55432
Mercy and Unity Cancer Center at Mercy Hospital
Coon Rapids, Minnesota, United States, 55433
Miller-Dwan Medical Center
Duluth, Minnesota, United States, 55805
Park Nicollet Health Services
St. Louis Park, Minnesota, United States, 55416
Regions Hospital Cancer Care Center
St. Paul, Minnesota, United States, 55101
Ridgeview Medical Center
Waconia, Minnesota, United States, 55387
Saint Francis Cancer Center
Shakopee, Minnesota, United States, 55379
St. Joseph's Hospital
St Paul, Minnesota, United States, 55102
St. Joseph's Medical Center
Brainerd, Minnesota, United States, 56401
St. Mary's - Duluth Clinic Cancer Center
Duluth, Minnesota, United States, 55805
United Hospital
St. Paul, Minnesota, United States, 55102
Meeker County Memorial Hospital
Lichfield, Minnesota, United States, 55355
Fergus Falls, Minnesota, United States, 56537
Alexandria, Minnesota, United States, 56308
Alexandria, Minnesota, United States, 56308
Woodwinds Health Campus
Woodbury, Minnesota, United States, 55125
United States, Mississippi
Hattiesburg Clinic, P.A.
Hattiesburg, Mississippi, United States, 39401
United States, Nebraska
Bergan Mercy Medical Center
Omaha, Nebraska, United States, 68124
Bryan LGH Medical Center West
Lincoln, Nebraska, United States, 68502
Cancer Resource Center - Lincoln
Lincoln, Nebraska, United States, 68510
CCOP - Missouri Valley Cancer Consortium
Omaha, Nebraska, United States, 68106
Creighton University Medical Center
Omaha, Nebraska, United States, 68131-2197
Immanuel Medical Center
Omaha, Nebraska, United States, 68122
St. Elizabeth Regional Medical Center
Lincoln, Nebraska, United States, 68510
United States, New Jersey
Cancer Institute of New Jersey at Hamilton
Hamilton, New Jersey, United States, 08690
Cancer Institute of New Jersey at the Cooper University Hospital - Voorhees
Voorhees, New Jersey, United States, 08043
Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical School
New Brunswick, New Jersey, United States, 08903
Carol G. Simon Cancer Center at Morristown Memorial Hospital
Morristown, New Jersey, United States, 07962
Fox Chase Virtua Health Cancer Program at Virtua West Jersey
Voorhees, New Jersey, United States, 08043
Fox Chase Virtua Health Cancer Program - Marlton
Marlton, New Jersey, United States, 08053
Mountainside Hospital Cancer Center
Montclair, New Jersey, United States, 07042
Overlook Hospital
Summit, New Jersey, United States, 07902
Shore Memorial Hospital - Somers Point
Somers Point, New Jersey, United States, 08244
United States, New York
Albert Einstein Cancer Center at Albert Einstein College of Medicine
Bronx, New York, United States, 10461
Our Lady of Mercy Medical Center Comprehensive Cancer Center
Bronx, New York, United States, 10466
United States, Ohio
Licking Memorial Cancer Care Program at Licking Memorial Hospital
Newark, Ohio, United States, 43055
Adena Regional Medical Center
Chillicothe, Ohio, United States, 45601
Akron City Hospital
Akron, Ohio, United States, 44309-2090
Case Comprehensive Cancer Center
Cleveland, Ohio, United States, 44106
CCOP - Columbus
Columbus, Ohio, United States, 43215
CCOP - Dayton
Dayton, Ohio, United States, 45429
Charles F. Kettering Memorial Hospital
Kettering, Ohio, United States, 45429
Community Hospital of Springfield and Clark County
Springfield, Ohio, United States, 45505
David L. Rike Cancer Center at Miami Valley Hospital
Dayton, Ohio, United States, 45409
Doctors Hospital at Ohio Health
Columbus, Ohio, United States, 43228
Fairfield Medical Center
Lancaster, Ohio, United States, 43130
Genesis - Good Samaritan Hospital
Zanesville, Ohio, United States, 43701
Good Samaritan Hospital
Dayton, Ohio, United States, 45406
Grady Memorial Hospital
Delaware, Ohio, United States, 43015
Grandview Hospital
Dayton, Ohio, United States, 45405
UVMC Cancer Care Center at Upper Valley Medical Center
Troy, Ohio, United States, 45373-1300
Mercy Medical Center
Springfield, Ohio, United States, 45504
MetroHealth's Cancer Care Center at MetroHealth Medical Center
Cleveland, Ohio, United States, 44109
Middletown Regional Hospital
Middletown, Ohio, United States, 45044
Mount Carmel Cancer Services at Mount Carmel St. Ann's Hospital
Westerville, Ohio, United States, 43081
Mount Carmel West Hospital
Columbus, Ohio, United States, 43222
Riverside Methodist Hospital Cancer Care
Columbus, Ohio, United States, 43214-3998
Ruth G. McMillan Cancer Center at Greene Memorial Hospital
Xenia, Ohio, United States, 45385
Samaritan North Cancer Care Center
Dayton, Ohio, United States, 45415
St. Rita's Medical Center
Lima, Ohio, United States, 45801
Strecker Cancer Center at Marietta Memorial Hospital
Marietta, Ohio, United States, 45750
University Hospitals Ireland Cancer Center at Mercy Medical Center
Canton, Ohio, United States, 44708
Grant Riverside Cancer Services
Columbus, Ohio, United States, 43215
Veterans Affairs Medical Center - Dayton
Dayton, Ohio, United States, 45428
United States, Pennsylvania
Bryn Mawr Hospital
Bryn Mawr, Pennsylvania, United States, 19010
CCOP - MainLine Health
Wynnewood, Pennsylvania, United States, 19096
Frank M. and Dorothea Henry Cancer Center at Geisinger Wyoming Valley Medical Center
Wilkes-Barre, Pennsylvania, United States, 18711
Lankenau Cancer Center at Lankenau Hospital
Wynnewood, Pennsylvania, United States, 19096
Geisinger Medical Group
State College, Pennsylvania, United States, 16801
Geisinger Medical Center
Danville, Pennsylvania, United States, 17822-0001
Paoli Memorial Hospital
Paoli, Pennsylvania, United States, 19301-1792
Reading Hospital and Medical Center
Reading, Pennsylvania, United States, 19612-6052
St. Joseph Medical Center
Reading, Pennsylvania, United States, 19604
St. Luke's Hospital Cancer Center
Bethlehem, Pennsylvania, United States, 18015
United States, South Dakota
Avera Cancer Institute
Sioux Falls, South Dakota, United States, 57105
Medical X-Ray Center, PC
Sioux Falls, South Dakota, United States, 57105
Sioux Valley Hospital and University of South Dakota Medical Center
Sioux Falls, South Dakota, United States, 57117-5039
United States, Tennessee
Vanderbilt-Ingram Cancer Center
Nashville, Tennessee, United States, 37232
United States, Texas
CCOP - Scott and White Hospital
Temple, Texas, United States, 76508
United States, Wisconsin
Dean Medical Center - Fish Hatchery
Madison, Wisconsin, United States, 53715
Green Bay Oncology, Limited - Oconto Falls
Oconto Falls, Wisconsin, United States, 54154
Green Bay Oncology, Limited - Sturgeon Bay
Sturgeon Bay, Wisconsin, United States, 54235
St. Vincent Hospital Regional Cancer Center
Green Bay, Wisconsin, United States, 54307-3508
Green Bay Oncology, Limited at St. Vincent Hospital
Green Bay, Wisconsin, United States, 54301-3526
Gundersen Lutheran Cancer Center at Gundersen Lutheran Medical Center
La Crosse, Wisconsin, United States, 54601
Marshfield Clinic - Marshfield Center
Marshfield, Wisconsin, United States, 54449
St. Mary's Hospital Medical Center - Green Bay
Green Bay, Wisconsin, United States, 54303
Green Bay Oncology, Limited at St. Mary's Hospital
Green Bay, Wisconsin, United States, 54303
Sponsors and Collaborators
Eastern Cooperative Oncology Group
North Central Cancer Treatment Group
Investigators
Study Chair: Stacy L. Moulder, MD H. Lee Moffitt Cancer Center and Research Institute
Investigator: Joseph A. Sparano, MD Albert Einstein College of Medicine of Yeshiva University
Study Chair: Edith A. Perez, MD Mayo Clinic
  More Information

Additional Information:
Publications:
Moulder SL, Wang M, Gradishar W, et al.: A phase II trial of trastuzumab, weekly ixabepilone and carboplatin (TIC) in patients with HER2/neu-positive (HER2+) metastatic breast cancer (MBC): a trial coordinated by the Eastern Cooperative Oncology Group (E2103). [Abstract] American Society of Clinical Oncology 2007 Breast Cancer Symposium, 7-8 September 2007, San Francisco, California A-152, 2007.

Study ID Numbers: CDR0000350220, ECOG-E2103, NCCTG-E2103
Study First Received: February 10, 2004
Last Updated: February 6, 2009
ClinicalTrials.gov Identifier: NCT00077376     History of Changes
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
stage IV breast cancer
recurrent breast cancer
male breast cancer

Additional relevant MeSH terms:
Molecular Mechanisms of Pharmacological Action
Skin Diseases
Antineoplastic Agents
Epothilones
Mitosis Modulators
Breast Neoplasms
Carboplatin
Antimitotic Agents
Pharmacologic Actions
Neoplasms
Neoplasms by Site
Therapeutic Uses
Tubulin Modulators
Trastuzumab
Breast Diseases

ClinicalTrials.gov processed this record on November 27, 2009