Patients with inflammatory or locally advanced operable breast cancer MedDRA version: 6.1 Level: PT Classification code 10021980
Conditions
Sponsors
ROCHE
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients with histologically proven stage III, or inflammatory breast cancer Female patients >18 years ER/PgR positive or negative and HER-2 negative patients No treatment with previous chemotherapy/endocrine therapy Performance status 0-1 (ECOG scale) No evidence of distant metastatic disease No other primary tumors within the last 5 years prior to enrolment, except for adequately treated carcinoma in situ of the cervix or basal cell skin cancer. No significant concomitant illness such as diabetes, cardiovascular, renal, or neurological impairments Absence of psychiatric illness undermining a correct understanding of the treatment program WBC >3,000/mm3; Neutrophils >2,000/mm3; Platelets >100,000/mm3; Haemoglobin >9 g/dL AST, ALT, gamma-GT 2+ proteinuria on dipstick urinalysis at baseline, should undergo a 24-hour urine collection and must demonstrate 60 ml/min (actual or calculated by Cockcroft-Gault method) The use of full-dose oral or parenteral anticoagulants is permitted as long as the INR, or appropriate monitoring test is within therapeutic limits and the patient has been on a stable dose of anticoagulants for at least two weeks at the time of enrolment. Patients not receiving anti coagulant medication must have an INR =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Primary breast cancer with histology other than adenocarcinoma. Primary breast carcinoma with any stage other than III. Patients with other non-malignant uncontrolled systemic diseases that would preclude trial entry in the opinion of the investigator. History or evidence or inherited bleeding diathesis or coagulopathy with the risk of bleeding Chronic daily treatment with aspirin (>325 mg/day) or clopidogrel (>75 mg/day) Serious non-healing wound, peptic ulcer, or bone fracture Major surgical procedure, open biopsy or significant traumatic injury within 28 days prior to enrolment, or minor surgical procedures, within 24 hours prior to enrolment History of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within 6 months of enrolment Clinical grade greater than or equal to 2 peripheral neuropathy Pregnant or lactating females. Serum pregnancy test to be assessed within 7 days prior to study treatment start, or within 14 days with a confirmatory urine pregnancy test within 7 days prior to study treatment start. Patients who are receiving other investigational drugs
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To determine the rate of pathological complete responses (pCR);Secondary Objective: - To determine the objective response rate (RR), disease-free interval (DFI), overall survival (OS), and rate of breast conservative surgery (BCS). - To evaluate the safety of this regimen.;Primary end point(s): Rate of pathological complete responses | — |
Countries
Italy
Outcome results
None listed