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Sponsored by: |
Consorzio Oncotech |
Information provided by: | Consorzio Oncotech |
ClinicalTrials.gov Identifier: | NCT00751868 |
The purpose of this study is to assess the feasibility of Ixabepilone (4 cycles) administered every 14 days with the support of G-CSF sequentially to the combination of Fluorouracil, Epirubicin and Cyclophosphamide (4 cycles) administered every 14 days with the support of G-CSF.
To evaluate the efficacy (in terms of pathologic Complete Responses in the breast and in the axilla), the dose reduction rate, the median treatment delay and the discontinuation rate due to toxicity of the regimen.
Condition | Intervention | Phase |
Breast Cancer |
Drug: Ixabepilone |
Phase II |
Genetics Home Reference related topics: | breast cancer |
MedlinePlus related topics: | Breast Cancer Cancer |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
Official Title: | NEO-ADIXERN (NEO-ADjuvant IXabepilone in ER-Negative Breast Cancer). A Feasibility Study of Dose-Dense FEC With G-CSF Support Followed by Dose-Dense Ixabepilone With G-CSF Support as Neoadjuvant Chemotherapy in ER-Negative Breast Cancer |
Estimated Enrollment: | 48 |
Study Start Date: | September 2008 |
Estimated Study Completion Date: | September 2009 |
Estimated Primary Completion Date: | May 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
1: Experimental
A goal of 48 patients will be enrolled in this study by 16 Italian centres of the GIM (Gruppo Italiano Mammella) Group. Subjects must meet all of the inclusion criteria and none of the exclusion criteria to be enrolled in the study
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Drug: Ixabepilone
Ixabepilone is administered as 3-hour intravenous infusion (iv) at the dose of 40 mg/mq, every 14 days for 4 cycles (with G-CSF support), sequentially to Fluorouracil 600 mg/mq as intravenous (iv) infusion, Epirubicin 90 mg/mq as intravenous (iv) bolus and Cyclophosphamide 600 mg/mq as intravenous (iv) infusion every 14 days for 4 cycles (with G-CSF support)
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Ages Eligible for Study: | 18 Years to 70 Years |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Italy | |||||
Ist. Nazionale per lo Studio e la Cura dei Tumori - Fondazione Pascale | |||||
Napoli, Italy, 80131 | |||||
Sub-Investigator: Andrea AD De Matteis, Doctor | |||||
Università Federico II | Not yet recruiting | ||||
Napoli, Italy, 80131 | |||||
Sub-Investigator: Sabino SD De Placido, Doctor | |||||
Istituto Regina Elena | Not yet recruiting | ||||
Roma, Italy, 00100 | |||||
Sub-Investigator: Francesco FC Cognetti, Doctor | |||||
Italy, BG | |||||
Azienza Osped.Treviglio - Caravaggio | Not yet recruiting | ||||
Treviglio, BG, Italy, 24047 | |||||
Sub-Investigator: Sandro SB Barni, Doctor | |||||
Italy, BN | |||||
Azienda Ospedaliera G. Rummo | Not yet recruiting | ||||
Benevento, BN, Italy, 82100 | |||||
Sub-Investigator: Bruno BD Daniele, Doctor | |||||
Italy, CB | |||||
Ospedale Civile di Campobasso - A. Cardarelli | Not yet recruiting | ||||
Campabasso, CB, Italy, 86100 | |||||
Sub-Investigator: Sante SR Romito, Doctor | |||||
Italy, CH | |||||
Ospedale civile Renzetti di Lanciano | Not yet recruiting | ||||
Lanciano, CH, Italy, 66034 | |||||
Sub-Investigator: Antonio AN Nuzzo, Doctor | |||||
Italy, CO | |||||
Azienda Ospedaliera S. Anna | Not yet recruiting | ||||
Como, CO, Italy, 22100 | |||||
Sub-Investigator: Monica MG Giordano, Doctor | |||||
Italy, CT | |||||
Azienda Ospedaliera Nesina Garibaldi | Not yet recruiting | ||||
Catania, CT, Italy, 95124 | |||||
Sub-Investigator: Roberto RB Bordonaro, Doctor | |||||
Italy, GE | |||||
I.S.T. - Istituto Nazionale per la Ricerca sul Cancro | Not yet recruiting | ||||
Genova, GE, Italy, 16131 | |||||
Sub-Investigator: Lucia LD Del Mastro, Doctor | |||||
Italy, MC | |||||
Presidio Ospedaliero di Macerata | Not yet recruiting | ||||
Mecerata, MC, Italy, 62100 | |||||
Sub-Investigator: Luciano LL Latini, Doctor | |||||
Italy, Milano | |||||
I.R.C.C.S. Multimedica - Casa di Cura Accreditata | Not yet recruiting | ||||
Sesto San Giovanni, Milano, Italy, 20099 | |||||
Sub-Investigator: Ornella OG Gottardi, Doctor | |||||
Italy, PG | |||||
Azienda Ospedaliera R. Silvestrini | Not yet recruiting | ||||
Perugia, PG, Italy, 06132 | |||||
Sub-Investigator: Lucio LC Crinò, Doctor | |||||
Italy, SS | |||||
Azienda Ospedaliera SS. Annunziata | Not yet recruiting | ||||
Sassari, SS, Italy, 07100 | |||||
Sub-Investigator: Antonio AC Contù, Doctor | |||||
Italy, Verona | |||||
Ospedale S. Cuore Don Calabria | Not yet recruiting | ||||
Negrar, Verona, Italy, 37024 | |||||
Principal Investigator: Marco MV Venturini, Doctor |
Consorzio Oncotech |
Principal Investigator: | Marco MV Venturini, Doctor | Ospedale Sacro Cuore - Dipartimento di Oncologia Medica |
Responsible Party: | Ospedale S. Cuore Don Calabria - Negrar Verona ( Marco Venturini ) |
Study ID Numbers: | GIM9-NEO-ADIXERN |
First Received: | September 11, 2008 |
Last Updated: | September 11, 2008 |
ClinicalTrials.gov Identifier: | NCT00751868 |
Health Authority: | Italy: Ministry of Health |
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