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Sponsored by: |
Consorzio Oncotech |
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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 |
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Breast Cancer |
Drug: Ixabepilone |
Phase II |
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 |
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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 | |
Università Federico II | |
Napoli, Italy, 80131 | |
Istituto Regina Elena | |
Roma, Italy, 00100 | |
Italy, BG | |
Azienza Osped.Treviglio - Caravaggio | |
Treviglio, BG, Italy, 24047 | |
Italy, BN | |
Azienda Ospedaliera G. Rummo | |
Benevento, BN, Italy, 82100 | |
Italy, CB | |
Ospedale Civile di Campobasso - A. Cardarelli | |
Campabasso, CB, Italy, 86100 | |
Italy, CH | |
Ospedale civile Renzetti di Lanciano | |
Lanciano, CH, Italy, 66034 | |
Italy, CO | |
Azienda Ospedaliera S. Anna | |
Como, CO, Italy, 22100 | |
Italy, CT | |
Azienda Ospedaliera Nesina Garibaldi | |
Catania, CT, Italy, 95124 | |
Italy, GE | |
I.S.T. - Istituto Nazionale per la Ricerca sul Cancro | |
Genova, GE, Italy, 16131 | |
Italy, MC | |
Presidio Ospedaliero di Macerata | |
Mecerata, MC, Italy, 62100 | |
Italy, Milano | |
I.R.C.C.S. Multimedica - Casa di Cura Accreditata | |
Sesto San Giovanni, Milano, Italy, 20099 | |
Italy, PG | |
Azienda Ospedaliera R. Silvestrini | |
Perugia, PG, Italy, 06132 | |
Italy, SS | |
Azienda Ospedaliera SS. Annunziata | |
Sassari, SS, Italy, 07100 | |
Italy, Verona | |
Ospedale S. Cuore Don Calabria | |
Negrar, Verona, Italy, 37024 |
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 |
Study First Received: | September 11, 2008 |
Last Updated: | September 11, 2008 |
ClinicalTrials.gov Identifier: | NCT00751868 |
Health Authority: | Italy: Ministry of Health |
breast cancer Clinical T score >=2 ER negative breast cancer, independently from PgR and HER2 status Females between 18 and 70 years |
ECOG performance status 0-1 No prior treatment for breast cancer excluding therapy for DCIS Histological documented diagnosis of breast cancer by incisional biopsy |
Naphazoline Oxymetazoline Skin Diseases Guaifenesin Phenylephrine Fluorouracil |
Epothilones Breast Neoplasms Phenylpropanolamine Cyclophosphamide Epirubicin Breast Diseases |
Neoplasms Neoplasms by Site Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Therapeutic Uses |
Mitosis Modulators Tubulin Modulators Antimitotic Agents Pharmacologic Actions |