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Phase II Randomized Trial of Weekly and Every 3-week Ixabepilone in Metastatic Breast Cancer (MBC) Patients


Phase 2
18 Years
N/A
Not Enrolling
Female
Metastatic Breast Cancer

Thank you

Trial Information

Phase II Randomized Trial of Weekly and Every 3-week Ixabepilone in Metastatic Breast Cancer (MBC) Patients


Inclusion Criteria:



- Has MBC that is measurable by RECIST or has nonmeasurable disease with serum CA27.29
(or CA15.3) ≥ 50

- Has Human Epidermal Growth Factor Receptor 2 (HER2) negative breast cancer

- Prior chemotherapy is permitted with no limit on the number of prior regimens

- Two weeks or more have elapsed since last chemotherapy or radiation treatment

- Has an Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) of 0-2

- Is female, ≥ 18 yrs of age

- Protocol defined appropriate laboratory values

- Negative pregnancy test within 7 calendar days prior to registration

- Has signed a patient informed consent

Exclusion Criteria:

- Had prior treatment with ixabepilone or other epothilones

- Has HER2+ disease

- Has a known, prior, severe (National Cancer Institute Common Terminology Criteria
Adverse Events [NCI CTCAE] Grade 3-4) history of hypersensitivity reaction to a drug
formulated in Cremophor ® EL (polyoxyethylated castor oil)

- Is receiving concurrent immunotherapy, hormonal therapy or radiation therapy

- Is receiving concurrent investigational therapy or has received such therapy within
the past 30 days

- Has peripheral neuropathy > Grade 1

- Has evidence of central nervous system (CNS) involvement requiring radiation or
steroid treatment. Participants with stable brain metastases who are off steroids at
least 2 weeks are eligible

- Is pregnant or breast feeding

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:

Progression-Free Survival (PFS) at 6 Months (6-month PFS Rate): Proportion of Participants Progression Free at 6 Months

Outcome Description:

PFS at 6 months was defined as proportion of participants who neither progressed nor died before 6 months. Computed using Kaplan-Meier estimates.

Outcome Time Frame:

From the date of randomization to 6-months on study

Safety Issue:

No

Principal Investigator

Bristol-Myers Squibb

Investigator Role:

Study Director

Investigator Affiliation:

Bristol-Myers Squibb

Authority:

United States: Food and Drug Administration

Study ID:

CA163-132

NCT ID:

NCT00593827

Start Date:

May 2008

Completion Date:

August 2010

Related Keywords:

  • Metastatic Breast Cancer
  • Breast Neoplasms

Name

Location

Ocala Oncology Center Ocala, Florida  34474
Cancer Centers of the Carolinas Greenville, South Carolina  29605
Missouri Cancer Associates Columbia, Missouri  65201
Southwest Cancer Care Poway, California  92064
New Mexico Cancer Care Associates Santa Fe, New Mexico  87505-7670
Tyler Cancer Center Tyler, Texas  75702
Cancer Care Northwest Spokane, Washington  99202
Hope Center Terre Haute, Indiana  47809
New York Oncology Hematology, P.C. Albany, New York  12208
Interlakes Oncology & Hematology, P.C. Rochester, New York  14623
Texas Oncology Dallas, Texas  
Texas Oncology, PA Dallas, Texas  75246-2006
Florida Cancer Institute New Port Richey, Florida  34652
Central Indiana Cancer Centers Indianapolis, Indiana  46227
Minnesota Oncology Hematology, P.A. Minneapolis, Minnesota  55407
Texas Cancer Center at Medical City Dallas, Texas  75230
Hematology Oncology Associates Phoenix, Arizona  85012
Arch Medical Services, INC. St. Louis, Missouri  63142
Texas Cancer Center Abilene, Texas  79606
Longview Cancer Center Longview, Texas  75601
Texas Cancer Center of Mesquite Mesquite, Texas  75150
Comprehensive Cancer Center of Nevada Las Vegas, Nevada  89109
Raleigh Hematology Oncology Associates Cary, North Carolina  27511
Northern Arizona Hematology & Oncology Associates Sedona, Arizona  86336
Deke Slayton Cancer Center Webster, Texas  77589
Puget Sound Cancer Centers Edmonds, Washington  98026
Northwest Cancer Specialists, PC Vancouver, Washington  98684
Maryland Oncology Hematology, P.A. Columbia, Maryland  21044
Texas Cancer Center - Sherman Sherman, Texas  75090-0504
Oncology & Hematology Associates of Southwest Virginia, Inc. Salem, Virginia  24153
Cancer Care & Hematology Specialists of Chicagoland Niles, Illinois  60714
Yakima Valley Memorial Hospital/North Star Lodge Yakima, Washington  98902
Texas Oncology Cancer Care and Research Center Waco, Texas  76712
South Texas Cancer Center Corpus Christi, Texas  78405
Kansas City Cancer Center, LLC Kansas City, Missouri  64131
Texas Oncology - Odessa Odessa, Texas  79761
Regional Cancer Care Durham, North Carolina  27704
Birmingham Hematology & Oncology Associates Llc Birmingham, Alabama  35205
Arizona Oncology Associates D.B.A. Hematology Oncology Tucson, Arizona  85704
Cancer Centers Of Florida, P.A Ocoee, Florida  34761
Alliance Hematology Oncology, Pa Westminster, Maryland  21157
Hematology-Oncology Assoc. Of Northern Nj, Pa Morristown, New Jersey  NJ
Texas Oncology-Central Austin Cancer Center Austin, Texas  78731
Mamie Mcfaddin Ward Cancer Center Texas Oncology Beaumont, Texas  77702
Texas Oncology/Methodist Charlton Cancer Ctr Dallas, Texas  75237
Baylor Sammons Cancer Ctr Dallas, Texas  75246
Texas Oncology Sammons Cancer Center Dallas, Texas  75246
Texas Oncology - Lake Vista Cancer Center Lewisville, Texas  75067
Paris Regional Cancer Center Lab Paris, Texas  75460
Texas Oncology Cancer Center - Sugar Land Sugar Land, Texas  77479
Evergreen Hematology And Oncology Spokane, Washington  99218