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Sponsored by: |
Bristol-Myers Squibb |
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Information provided by: | Bristol-Myers Squibb |
ClinicalTrials.gov Identifier: | NCT00633464 |
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 |
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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 |
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 |
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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
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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
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Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
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. |
Austria | |
Local Institution | Not yet recruiting |
Voecklabruck, Austria, 4840 | |
Contact: Site 015 | |
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 |
Brno, Czech Republic, 656 53 | |
Contact: Site 020 | |
Local Institution | Recruiting |
Praha 2, Czech Republic, 128 08 | |
Contact: Site 021 | |
Local Institution | Not yet recruiting |
Prague 5, Czech Republic, 150 06 | |
Contact: Site 046 | |
France | |
Local Institution | Recruiting |
Toulouse Cedex, France, 31052 | |
Contact: Site 004 | |
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 |
Dijon Cedex, France, 21079 | |
Contact: Site 024 | |
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 |
Napoli, Italy, 80131 | |
Contact: Site 030 | |
Local Institution | Recruiting |
Napoli, Italy, 80131 | |
Contact: Site 029 | |
Local Institution | Recruiting |
Lecce, Italy, 73100 | |
Contact: Site 011 | |
Poland | |
Local Institution | Recruiting |
Gdansk, Poland, 80-211 | |
Contact: Site 002 | |
Local Institution | Not yet recruiting |
Warszawa, Poland, 00-909 | |
Contact: Site 031 | |
Local Institution | Not yet 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 |
Study Director: | Bristol-Myers Squibb | Bristol-Myers Squibb |
Responsible Party: | Bristol-Myers Squibb ( Study Director ) |
Study ID Numbers: | CA163-139 |
Study First Received: | March 5, 2008 |
Last Updated: | May 6, 2009 |
ClinicalTrials.gov Identifier: | NCT00633464 History of Changes |
Health Authority: | France: Afssaps - French Health Products Safety Agency |
Skin Diseases Epothilones Tubulin Modulators Cetuximab |
Breast Neoplasms Antimitotic Agents Breast Diseases |
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 |