Know Cancer

or
forgot password

A Phase II, Multicenter, Randomized, Open-Label Study Comparing Eribulin Mesylate and Ixabepilone in Causing or Exacerbating Neuropathy in Patients With Advanced Breast Cancer


Phase 2
18 Years
N/A
Open (Enrolling)
Female
Breast Cancer

Thank you

Trial Information

A Phase II, Multicenter, Randomized, Open-Label Study Comparing Eribulin Mesylate and Ixabepilone in Causing or Exacerbating Neuropathy in Patients With Advanced Breast Cancer

Inclusion Criteria


Inclusion criteria:

1. Female subjects with confirmed locally recurrent or metastatic carcinoma of the breast
who have received prior taxane therapy and at least one prior cytotoxic chemotherapy
regimen for advanced disease.

Exclusion criteria:

1. Subjects who have received prior ixabepilone therapy.

2. Subjects with prior participation in an eribulin clinical study, even if not assigned
to eribulin treatment.

3. Subjects with pre-existing neuropathy Grade greater than or equal to 2.

4. Subjects with a history of diabetes mellitus Type 1 or 2.

5. Subjects with bilateral mastectomy which included bilateral axillary lymph node
dissection.

6. Subjects with missing digits required for vibration assessment.

7. Subjects with any other concurrent diseases or conditions that would be expected to
interfere with neuropathy assessments, which may include vitamin deficiency, sequelae
of cerebrovascular disease, thyroid insufficiency, lumbar or cervical radiculopathy,
or alcoholic or inflammatory neuropathy.

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Percent of subjects with neuropathy adverse events (AEs) graded according to NCI CTCAE (version 3.0) and coded according to the current version of Medical Dictionary for Regulatory Activities (MedDRA).

Outcome Time Frame:

Neuropathy assessments are performed at the start of Cycles 2-6 and subsequently at every third cycle, end-of-treatment visit, and post-treatment follow-up.

Safety Issue:

Yes

Authority:

United States: Food and Drug Administration

Study ID:

E7389-G000-209

NCT ID:

NCT00879086

Start Date:

March 2009

Completion Date:

Related Keywords:

  • Breast Cancer
  • Breast Cancer
  • Oncology
  • Breast Neoplasms

Name

Location

Queens Cancer Center of Queens HospitalJamaica, New York  11432
Virginia Oncology AssociatesNewport News, Virginia  23606
Montefiore Medical CenterBronx, New York  10467-2490
Ocala Oncology CenterOcala, Florida  34474
Hematology Oncology AssociatesAtlantis, Florida  33462
Lone Star OncologyAustin, Texas  78759
Tyler Cancer CenterTyler, Texas  75702
Northern Utah AssociatesOgden, Utah  84403
Comprehensive Cancer CenterGlendale, California  91204
Henry Ford Health SystemsDetroit, Michigan  48202
Hematology Oncology Associates of IllinoisSkokie, Illinois  60077
North Texas Regional Cancer CenterPlano, Texas  75075
Robert R. Carroll, MD, PAGainesville, Florida  32605
Hematology and Oncology SpecialistsNew Orleans, Louisiana  70115
Texas Oncology, PADallas, Texas  75246-2006
Decatur Memorial HospitalDecatur, Illinois  62526
Central Indiana Cancer CentersIndianapolis, Indiana  46227
Texas Cancer Center at Medical CityDallas, Texas  75230
Josephine Ford Cancer CenterDetroit, Michigan  48202
Hematology Oncology Associates of Treasure CoastPort St. Lucie, Florida  34952
University of Southern CaliforniaLos Angeles, California  90033
Washington County HospitalHagerstown, Maryland  21740
Northwest Cancer CenterHouston, Texas  77042
Maryland Oncology Hematology, PAColumbia, Maryland  21044
Summit Medical GroupSummit, New Jersey  07901
Northwest Cancer SpecialistsPortland, Oregon  97225
Henry Ford Medical Center-FairlaneDearborn, Michigan  48126
South Texas Institute of CancerCorpus Christi, Texas  78405
Cancer Center of North CarolinaRaleigh, North Carolina  27614
Medical Specialists of the Palm BeachesLake Worth, Florida  33454
Northern AZ Hematology and Oncology AssociatesSedona, Arizona  86336
Healing Hands Oncology and Medical CareHawthorne, California  90250
Comprehensive Cancer Care Specialist of BocaBoca Raton, Florida  33428
Oncology and Hematology Associates of West BrowardTamarac, Florida  33321
Heartland Oncology HematologyCouncil Bluffs, Iowa  51503
Metairie Institute of Comprehensive HealthMetairie, Louisiana  70006
Henry Ford Medical Center FarmingtonWest Bloomfield, Michigan  48322
Joan Knechel Cancer CenterMt. Arlington, New Jersey  07856
Saint Vincent's Comprehensive Cancer CenterNew York, New York  10011
Weil Cornell Breast CenterNew York, New York  10065
Charleston Hematology Oncology Associates PACharleston, North Carolina  29403
Northwest Cancer Specialists HoytPortland, Oregon  97213-2996
Northwest Cancer Specialists Rose QuarterPortland, Oregon  97227
Texas Oncology-Sammons Cancer CenterDallas, Texas  75246
Texas Oncology, PA BedfordHouston, Texas  76033
Northwest Cancer Care Specialists, P.C.Vancouver, Washington  98686
Northwest Cancer Specialist VancouverVancouver, Washington  98684