A PILOT STUDY TESTING THE FEASIBILITY OF TWO DIFFERENTS REGIMENS INCORPORATING DOSE-DENSE DOCETAXEL AND CAPECITABINE-ORAL VINORELBINE IN THE ADJUVANT TREATMENT OF EARLY BREAST CANCER PATIENTS - DOSE DENSE DOCETAXE

AZIENDA USL 4 PRATO0 个研究点开始时间: 2009年9月3日最近更新: 2012年3月19日

研究概览

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•WRITTEN INFORMED CONSENT HISTOLOGICAL DIAGNOSIS OF POORLY HORMONE-SENSITIVE OR HORMONE- RESISTANT INFILTRATING BREAST CARCINOMA STAGE I OR II DISEASE AGE BETWEEN 18 AND 70 ECOG PERFORMANCE STATUS 0-1 NORMAL HEMATO-CHEMISTRY TESTS : ANC ≥ 1,500 MM3, PLT ≥ 100.000 MM3, HB ≥ 10 G/DL; GOT/GPT/ALKALINE PHOSPHATASE/ TOTAL BILIRUBIN ≤ 1.5 N; CREATININE ≤ 1 N NORMAL LEFT VENTRICULAR EJECTION FRACTION NEGATIVE PREGNANCY TEST (ONLY IN WOMEN OF CHILDBEARING AGE) CONSISTENT AND CORRECT USE OF ADEQUATE NON-HORMONAL METHODS OF BIRTH CONTROL (BARRIER METHODS OR INTRAUTERINE DEVICE) IN WOMEN OF CHILDBEARING AGE ALL SCREENING PROCEDURES OUTLINED IN THE PROTOCOL HAVE BEEN COMPLETED
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range

•o PRESENCE OF RELEVANT CO-MORBIDITIES WHICH MIGHT POTENTIALLY INCREASE THE RISK OF TREATMENT RELATED TOXICITIES o HISTORY OF RELEVANT CARDIAC DISEASES o PREGNANT OR LACTATING WOMEN o ANY FORM OF PRE-OPERATIVE BREAST CANCER TREATMENT o FACTORS OR DISEASES LIMITING CORRECT ADMINISTRATION OF ORAL THERAPIES o DEMENTIA, ALTERED MENTAL STATUS, OR ANY PSYCHIATRIC CONDITION THAT COULD PROHIBIT THE UNDERSTANDING OR RENDERING OF INFORMED CONSENT o CONCURRENT ANTI-CANCER THERAPIES OTHER THAN STUDY DRUGS o CONCURRENT TREATMENT WITH ORAL OR INTRAVENOUS STEROIDS o CONCURRENT TREATMENT WITH AN INVESTIGATIONAL AGENT OR PARTICIPATION IN ANY INVESTIGATIONAL DRUG STUDY WITHIN 4 WEEKS PRECEDING TREATMENT START. o MALE PATIENTS

发起方

AZIENDA USL 4 PRATO