BREAST CANCER MedDRA version: 9.1 Level: SOC Classification code 10038604
Conditions
Sponsors
AZIENDA USL 4 PRATO
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Secondary Objective: --;Primary end point(s): TREATMENT-RELATED TOXICITY FOR EACH REGIMEN;Main Objective: PRIMARY: TO ASSESS THE FEASIBILITY OF THE FOLLOWING REGIMENS IN THE ADJUVANT TREATMENT OF BREAST CANCER PATIENTS : REGIMEN 1 : EPIRUBICIN-CYCLOPHOSPHAMIDE (EC) X 4 CYCLES FOLLOWED BY DOSE-DENSE DOCETAXEL X 4 CYCLES + G-CSF (2 DOSE-LEVELS) REGIMEN 2 : CAPECITABINE-ORAL VINORELBINE X 4 CYCLES FOLLOWED BY DOSE-DENSE DOCETAXEL X 4 CYCLES + G-CSF (2 DOSE-LEVELS) LONG-TERM AIM : TO TEST THESE REGIMENS IN THE CONTEXT OF A PHASE III MULTICENTER TRIAL EVALUATING THE INTERACTION BETWEEN TUMOR PROLIFERATION STATUS AND ANTHRACYCLINES OR DOSE-DENSE DOCETAXEL ACTIVITY IN EARLY BREAST CANCER PATIENTS WITH ENDOCRINE-RESISTANT DISEASE | — |
Countries
Italy
Outcome results
None listed