Patients with primary breast cancer MedDRA version: 9.1 Level: LLT Classification code 10006187
Conditions
Sponsors
ISTITUTO SCIENTIFICO ROMAGNOLO PER LO STUDIO E LA CURA DEI TUMORI
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: •Patients must have histologically or cytologically confirmed primary breast cancer •Age =18 and 4 positive axillary nodes or high-risk breast cancer with 1cm and two or more of the following are present: histologic grade 3, Ki67>30%, estrogen receptor (ER) negativity, or lymphovascular invasion [39] •Adequate hematological, hepatic and renal function, as follows: hemoglobin = 9 g/dl, absolute neutrophil count =1,500/?L, platelets =100,000/?L, total bilirubin =1.5 x ULN, alkaline phosphatase, AST(SGOT) and ALT(SGPT) = 2.5 x ULN (= 5 x ULN if liver metastases present), serum creatinine = 1.5 x ULN or calculated creatinine clearance >50 mL/min. Either INR or APTT =65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: •Metastatic disease •Participation in another clinical trial with any investigational agents within 30 days prior to study screening. •Contraindications or hypersensitivity to study drugs; •Past (less than 10 years) or current history of malignant neoplasms, except for curatively treated 1) basal and squamous cell carcinoma of the skin or 2) carcinoma in situ of the cervix. NOTE: Patients with a prior malignancy diagnosed greater than 10 years in the past who have been curatively treated with surgery ONLY, WITHOUT radiation therapy or systemic therapy (chemotherapy or endocrine) are eligible for the study. Patients with any prior diagnosis of invasive breast cancer or melanoma, at any time, are excluded from this study. •Serious cardiac illness or medical conditions including but not confined to: History of documented congestive heart failure (CHF) or systolic dysfunction (LVEF 180mm Hg or diastolic >100mm Hg); •Other concurrent serious diseases that may interfere with planned treatment including severe pulmonary conditions/illness; •Malabsorption syndrome, any disease significantly affecting gastrointestinal function, or resection of the stomach or small bowel, or persons unable to swallow oral medication. Subjects with ulcerative colitis are also excluded; • Pregnant, lactating or women of childbearing potential without a negative pregnancy test – urine or serum, within 7 days prior to randomization, irrespective of the method of contraception used, including tubal ligation. • Women of childbearing potential, including women whose last menstrual period was <12 months ago (unless surgically sterile) who are unable or unwilling to use adequate contraceptive measures during study treatment. (adequate contraceptive measures are intra-uterine device, barrier method - condoms, diaphragm - also in conjunction with spermicidal jelly, or total abstinence. Oral, injectable or implant hormonal contraceptives are not allowed on this study)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Secondary Objective: toxicities, relapse free survival, overall survival;Primary end point(s): feasability of regimen;Main Objective: To assess the feasibility of neoadjuvant/adjuvant dose density regimen | — |
Countries
Italy
Outcome results
None listed