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Randomized Phase II of Ixabepilone Alone and Ixabepilone Plus Cetuximab as First-Line Treatment for Female Subjects With Triple Negative Locally Advanced Non-resectable and/or Metastatic Breast Cancer
This study is currently recruiting participants.
Verified by Bristol-Myers Squibb, July 2009
First Received: March 5, 2008   Last Updated: September 2, 2009   History of Changes
Sponsored by: Bristol-Myers Squibb
Information provided by: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT00633464
  Purpose

The purpose of this study is to estimate the response rate of ixabepilone monotherapy, and the combination if ixabepilone plus cetuximab as first-line treatment of female subjects with triple negative locally advanced non-resectable and/or metastatic breast cancer


Condition Intervention Phase
Triple Negative Locally Advanced Non-resectable Breast Cancer
Metastatic Breast Cancer
 Drug: ixabepilone
Drug: ixabepilone+cetuximab
 Phase II

Study Type: Interventional
Study Design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
Official Title: Randomized Phase II of Ixabepilone Alone and Ixabepilone Plus Cetuximab as First-Line Treatment for Female Subjects With Triple Negative (ER, PR, Her2 Negative) Locally Advanced Non-resectable and/or Metastatic Breast Cancer

Resource links provided by NLM:

Genetics Home Reference related topics: breast cancer
MedlinePlus related topics: Breast Cancer Cancer
Drug Information available for: Cetuximab Ixabepilone
U.S. FDA Resources

Further study details as provided by Bristol-Myers Squibb:

Primary Outcome Measures:
  • Objective Response Rate [ Time Frame: The subject will have an OR if their best overall response during the study is either a Complete Response or a Partial Response according to the RECIST criteria ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Progression free survival [ Time Frame: The time in days from randomization until the first date of documented progressive disease (PD) or death from any cause without prior documentation of progression ] [ Designated as safety issue: No ]
  • Time to response [ Time Frame: The time in days from first dosing until measurement criteria are first met for PR or CR (whichever is recorded first) ] [ Designated as safety issue: No ]
  • Duration of response [ Time Frame: the period measured in days from the time that measurement critiera are first met for CR or PR (whichever is recorded first) until the first date of documented progressive disease or death from any cause wihtout prior documentation of progression ] [ Designated as safety issue: No ]

Estimated Enrollment: 80
Study Start Date: June 2008
Estimated Study Completion Date: January 2012
Estimated Primary Completion Date: January 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
A: Experimental Drug: ixabepilone
Solution, IV, 40 mg/m2, 3-week cycle, study will be completed once all subjects have progressed or 15 months after the Last Patient First Visit, which ever comes first
B: Experimental Drug: ixabepilone+cetuximab
Solution, IV, loading dose 400 mg/m2 then 250mg/m2, weekly, study will be completed once all subjects have progressed or 15 months after the Last Patient First Visit, which ever comes first

  Eligibility

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

Inclusion Criteria:

  • Female subjects with triple negative (ER, PR, HER2 negative) locally advanced non-resectable and/or metastatic breast cancer
  • Prior adjuvant or neoadjuvant anthracycline-based chemotherapy

Exclusion Criteria:

  • Tumors that are FISH positive or IHC 3+
  • Neuropathy > Grade 1
  • Prior systemic therapy for metastatic disease
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00633464

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
Austria
Local Institution Recruiting
Innsbruck, Austria, 6020
Contact: Site 016            
Local Institution Recruiting
Graz, Austria, 8036
Contact: Site 017            
Local Institution Recruiting
Wien, Austria, 1090
Contact: Site 019            
Czech Republic
Local Institution Recruiting
Prague 5, Czech Republic, 150 06
Contact: Site 046            
Local Institution Recruiting
Praha 2, Czech Republic, 128 08
Contact: Site 021            
Local Institution Recruiting
Brno, Czech Republic, 656 53
Contact: Site 020            
France
Local Institution Recruiting
Dijon Cedex, France, 21079
Contact: Site 024            
Local Institution Recruiting
Paris Cedex 13, France, 75651
Contact: Site 005            
Local Institution Recruiting
Bayonne, France, 64100
Contact: Site 006            
Local Institution Recruiting
Lyon, France, 69008
Contact: Site 007            
Local Institution Recruiting
Saint Herblain Cedex, France, 44805
Contact: Site 022            
Local Institution Recruiting
Toulouse Cedex, France, 31052
Contact: Site 004            
Local Institution Recruiting
Saint Brieuc, France, 22015
Contact: Site 034            
Greece
Local Institution Recruiting
Thessaloniki, Greece, 54642
Contact: Site 013            
Local Institution Recruiting
Thessaloniki, Greece, 54642
Contact: Site 014            
Italy
Local Institution Recruiting
Lecce, Italy, 73100
Contact: Site 011            
Local Institution Recruiting
Napoli, Italy, 80131
Contact: Site 029            
Local Institution Recruiting
Napoli, Italy, 80131
Contact: Site 030            
Poland
Local Institution Recruiting
Gdansk, Poland, 80-211
Contact: Site 002            
Local Institution Recruiting
Warszawa, Poland, 00-909
Contact: Site 031            
Local Institution Recruiting
Olsztyn, Poland, 10-513
Contact: Site 044            
Spain
Local Institution Recruiting
Barcelona, Spain, 08221
Contact: Site 025            
Local Institution Recruiting
Barcelona, Spain, 08208
Contact: Site 027            
Local Institution Recruiting
Barcelona, Spain, 08036
Contact: Site 028            
Sponsors and Collaborators
Bristol-Myers Squibb
Investigators
Study Director: Bristol-Myers Squibb 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: http://www.fda.gov/MEDWATCH/safety.htm  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Bristol-Myers Squibb ( Study Director )
Study ID Numbers: CA163-139
Study First Received: March 5, 2008
Last Updated: September 2, 2009
ClinicalTrials.gov Identifier: NCT00633464     History of Changes
Health Authority: France: Afssaps - French Health Products Safety Agency

Study placed in the following topic categories:
Skin Diseases
Epothilones
Tubulin Modulators
Cetuximab
 Breast Neoplasms
Antimitotic Agents
Breast Diseases

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

ClinicalTrials.gov processed this record on September 10, 2009



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