A Phase II Combination of Trastuzumab and Ixabepilone Versus Trastuzumab and Docetaxel in Patients With Advanced and/or Metastatic Breast Cancer - Full Text View

Sponsored by:	Bristol-Myers Squibb
Information provided by:	Bristol-Myers Squibb
ClinicalTrials.gov Identifier:	NCT00490646

Purpose

Randomized Phase II of Ixabepilone Plus Trastuzumab vs. Docetaxel Plus Trastuzumab in Female Subjects with Her2+ Locally Advanced and/or Metastatic Breast Cancer

Condition	Intervention	Phase
Metastatic Breast Cancer	Drug: Ixabepilone & Trastuzumab Drug: Docetaxel & Trastuzumab	Phase II

Genetics Home Reference related topics: breast cancer

MedlinePlus related topics: Breast Cancer Cancer

Drug Information available for: Docetaxel Ixabepilone Trastuzumab

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	Randomized Phase II of Ixabepilone Plus Trastuzumab vs. Docetaxel Plus Trastuzumab in Female Subjects With Her2+ Locally Advanced and/or Metastatic Breast Cancer

Further study details as provided by Bristol-Myers Squibb:

Primary Outcome Measures:

Objective response rate [ Time Frame: 6 months after LPFV and end of study ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Progression-free survival [ Time Frame: at end of study ] [ Designated as safety issue: No ]
Duration of response [ Time Frame: at end of study ] [ Designated as safety issue: No ]
Time to response [ Time Frame: at end of study ] [ Designated as safety issue: No ]
Safety [ Time Frame: at end of study ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	80
Study Start Date:	February 2008
Estimated Study Completion Date:	November 2012
Estimated Primary Completion Date:	November 2012 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental	Drug: Ixabepilone & Trastuzumab Infusion, I.V., Ixabepilone 40mg/m², trastuzumab 2mg/kg (loading dose=4mg/kg), cycle = 21days, duration of combination therapy approx 10 cycles. Trastuzumab might continue up to 38 months
2: Active Comparator	Drug: Docetaxel & Trastuzumab Infusion, I.V., docetaxel 100mg/m², trastuzumab 2mg/kg (loading dose=4mg/kg), cycle = 21days, duration of combination therapy approx 10 cycles. Trastuzumab might continue up to 38 months

Eligibility

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

Criteria

Inclusion Criteria:

Locally advanced or metastatic HER2+ breast cancer
Measurable disease
LVEF ≥50%

Exclusion Criteria:

Prior chemo or trastuzumab for MBC
Relapse within 1 year after (neo)adjuvant taxane or trastuzumab
Neuropathy > grade 1
Significant cardiovascular disease
Any brain metastases

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00490646

Contacts

Contact: For participation information at a USA site use a phone number below. For site information outside the USA please email:		Clinical.Trials@bms.com
Contact: First line of email MUST contain NCT# & Site#. Only trial sites that are recruiting have contact information at this time.

Locations

France
Local Institution	Recruiting
Grenoble, France, 38028
Contact: Site 003
Local Institution	Recruiting
St Priest En Jarez, France, 42271
Contact: Site 004
Local Institution	Recruiting
Caen, France, F-14076
Contact: Site 005
Local Institution	Recruiting
Toulouse, France, 31078
Contact: Site 021
Local Institution	Recruiting
Le Havre, France, 76000
Contact: Site 027
Local Institution	Not yet recruiting
Montbeliard, France, 25000
Contact: Site 028
Local Institution	Not yet recruiting
Strasbourg, France, 67085
Contact: Site 029
Greece
Local Institution	Recruiting
Athens, Greece, 11522
Contact: Site 015
Local Institution	Recruiting
Pireaus, Greece, 18537
Contact: Site 016
Local Institution	Recruiting
Athens, Greece, 12462
Contact: Site 026
Italy
Local Institution	Recruiting
Modena, Italy, 41100
Contact: Site 007
Local Institution	Recruiting
Sora, Italy, 03039
Contact: Site 008
Local Institution	Recruiting
Brescia, Italy, 25123
Contact: Site 009
Local Institution	Recruiting
Bologna, Italy, 40138
Contact: Site 020
Local Institution	Not yet recruiting
Napoli, Italy, 80131
Contact: Site 030
Spain
Local Institution	Recruiting
Jaen, Spain, 23007
Contact: Site 017
Local Institution	Recruiting
Madrid, Spain, 28007
Contact: Site 019
Local Institution	Not yet recruiting
Madrid, Spain, 28034
Contact: Site 031
Turkey
Local Institution	Recruiting
Izmir, Turkey, 35100
Contact: Site 022
Local Institution	Recruiting
Izmir, Turkey, 35340
Contact: Site 023
Local Institution	Recruiting
Ankara, Turkey, 06100
Contact: Site 024
Local Institution	Recruiting
Ankara, Turkey, 06500
Contact: Site 025

Sponsors and Collaborators

Bristol-Myers Squibb

Investigators

Study Director:

Bristol-Myers Squibb

More Information

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

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

Responsible Party:	Bristol-Myers Squibb ( Study Director )
Study ID Numbers:	CA163-140, Eudract No: 2007-000721-21
Study First Received:	June 21, 2007
Last Updated:	January 6, 2009
ClinicalTrials.gov Identifier:	NCT00490646
Health Authority:	Italy: Ministry of Health

Keywords provided by Bristol-Myers Squibb:

Locally advanced and/or metastatic breast cancer

Study placed in the following topic categories:

Docetaxel
Skin Diseases
Epothilones

Trastuzumab
Breast Neoplasms
Breast Diseases

Additional relevant MeSH terms:

Neoplasms
Neoplasms by Site
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Therapeutic Uses

Mitosis Modulators
Tubulin Modulators
Antimitotic Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 14, 2009