Novel Epothilone Plus Capecitabine Versus Capecitabine Alone in Patients With Advanced Breast Cancer - Full Text View

Sponsor:	Bristol-Myers Squibb
Information provided by:	Bristol-Myers Squibb
ClinicalTrials.gov Identifier:	NCT00080301

Purpose

The purpose of this clinical research study is to learn if BMS-247550 added to the approved therapy of capecitabine is better than capecitabine alone in shrinking or slowing the growth of the cancer in women with metastatic breast cancer who are resistant to taxane and received anthracycline chemotherapy. The safety of this treatment will also be studied.

Condition	Intervention	Phase
Breast Cancer Metastases	Drug: Ixabepilone + Capecitabine Drug: Capecitabine	Phase III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	A Phase III Trial of Novel Epothilone BMS-247550 Plus Capecitabine Versus Capecitabine Alone in Patients With Advanced Breast Cancer Previously Treated With or Resistant to an Anthracycline and Who Are Taxane Resistant

Resource links provided by NLM:

Genetics Home Reference related topics: breast cancer

MedlinePlus related topics: Breast Cancer Cancer

Drug Information available for: Capecitabine Ixabepilone

U.S. FDA Resources

Further study details as provided by Bristol-Myers Squibb:

Primary Outcome Measures:

Progression-Free Survival (PFS) Per Independent Radiology Review Committee (IRRC) [ Time Frame: based on assessments every 6 weeks while on treatment until documented disease progression/unacceptable toxicity ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Overall Response Rate (ORR) Per IRRC [ Time Frame: based on assessments every 6 weeks while on treatment until documented disease progression/unacceptable toxicity ] [ Designated as safety issue: No ]
Duration of Response Per IRRC [ Time Frame: based on assessments every 6 weeks while on treatment until documented disease progression/unacceptable toxicity ] [ Designated as safety issue: No ]
Time to Response Per IRRC [ Time Frame: based on assessments every 6 weeks while on treatment until documented disease progression/unacceptable toxicity ] [ Designated as safety issue: No ]
Overall Survival (OS) [ Time Frame: from date of randomization until death ] [ Designated as safety issue: No ]
Treatment-Related Safety Summary [ Time Frame: safety was assessed on a continual basis every cycle while on-treatment and every 4 weeks post treatment until toxicities resolved or were deemed irreversible. ] [ Designated as safety issue: Yes ]
Symptom Assessment Score Changes From Baseline for Functional Assessment of Cancer Therapy-Breast Symptom Index (FBSI) [ Time Frame: Baseline and prior to each 21-day cycle of treatment, and at first posttreatment follow-up assessment. ] [ Designated as safety issue: No ]

Enrollment:	752
Study Start Date:	September 2003
Study Completion Date:	March 2008
Primary Completion Date:	November 2006 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
A: Experimental	Drug: Ixabepilone + Capecitabine Ixabepilone - Intravenous Solution, IV 40mg/m², Day 1 every 21 days, Until progression/unacceptable toxicity Capecitabine (Active Comparator) - Tablet, Oral, 2000 mg/m², Bid Days 1-14 every 21 days, Until progression/unacceptable toxicity
B: Active Comparator	Drug: Capecitabine Tablet, Oral, 2500 mg/m², Bid Days 1-14 every 21 days, Until progression/unacceptable toxicity

Eligibility

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

Criteria

Patients must have received either 2 or 3 prior chemotherapy regimens including adjuvant or neoadjuvant therapy.
Prior treatment must have included both an anthracycline (i.e., doxorubicin or epirubicin) and a taxane (i.e., paclitaxel or docetaxel).
Patients must have received a minimum cumulative dose of anthracycline or must be resistant to an anthracycline.
Patients must be resistant to taxane therapy.
Patients may not have any history of brain and/or leptomeningeal metastases.
Patients may not have CTC Grade 2 or greater neuropathy (motor or sensory).
Patients may have not have had prior treatment with an epothilone and/or capecitabine (i.e., Xeloda)

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00080301

Show 154 Study Locations

Sponsors and Collaborators

Bristol-Myers Squibb

Investigators

Study Director:

Bristol-Myers Squibb

More Information

Additional Information:

BMS Clinical Trials Disclosure This link exits the ClinicalTrials.gov site

For FDA Safety Alerts and Recalls refer to the following link www.fda.gov/MEDWATCH/safety.htm This link exits the ClinicalTrials.gov site

Phrma website - CSR synopsis This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Bristol-Myers Squibb ( Study Director )
Study ID Numbers:	CA163-046
Study First Received:	March 26, 2004
Results First Received:	May 1, 2009
Last Updated:	July 2, 2009
ClinicalTrials.gov Identifier:	NCT00080301 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Bristol-Myers Squibb:

Metastatic Breast Cancer

Additional relevant MeSH terms:

Antimetabolites
Capecitabine
Antimetabolites, Antineoplastic
Immunologic Factors
Molecular Mechanisms of Pharmacological Action
Skin Diseases
Antineoplastic Agents
Epothilones
Mitosis Modulators
Physiological Effects of Drugs
Breast Neoplasms
Antimitotic Agents

Immunosuppressive Agents
Pharmacologic Actions
Neoplasms
Neoplastic Processes
Neoplasms by Site
Pathologic Processes
Therapeutic Uses
Fluorouracil
Tubulin Modulators
Neoplasm Metastasis
Breast Diseases

ClinicalTrials.gov processed this record on November 09, 2009