Patient with early and locally advanced triple negative (ER, PgR and HER2 negative) breast cancer MedDRA version: 9.1 Level: LLT Classification code 10006187
Conditions
Sponsors
AZIENDA OSPEDALIERA POLICLINICO DI MODENA
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: ? Age ?18 years and 2+ proteinuria on dipstick urinalysis at baseline, should undergo a 24-hour urine collection and must demostrate =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: ? Presence of distant metastases ? Patients receiving any others investigational agents ? Major surgical procedure, open biopsy or significant traumatic injury within 28 days prior to randomization, or anticipation of the need for major surgery during the course of the study treatment, or minor surgical procedures within 24 hours prior to randomization ? History of allergic reactions attributed to compounds of similar chemical or biologic composition used in the study ? Uncontrolled intercurrent illness including, but not limited, to uncontrolled hypertension (systolic >150 mmHg and/or diastolic >100 mmHg)ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, symptomatic peripheral neuropathy, or psychiatric illness/social situations that would limit compliance with study requirements ? Serious non-healing wound, peptic ulcer, or bone fracture ? History of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within 6 months of randomization ? Pregnant women are excluded from this study because of the potential for teratogenic or abortifacient effects of agents included in this trial. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother, breastfeeding must be discontinued.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess the activity of this regimen in terms of pathological complete remission (pCR) rate;Secondary Objective: • To evaluate the safety of the combination • To evaluate the percentage of breast conservative surgery • To assess the objective response rate (clinical complete response plus partial response) • To estimate the time to disease progression and the overall survival • To assess the changes in Ki-67 index , EGFR pathway inhibition, and the effect of therapy on other markers characterizing triple negative disease diseases • To study the gene expression profile predicting pathological complete response and the change in gene expression profile with therapy • To study the correlation of VEGF genotype (SNPs) with response, toxicity outcome • To study the possibility of early response assessment with contrast-enhanced dynamics MRI.;Primary end point(s): ? The pathological Complete Response, defined by complete absence of infiltrating tumor cells in the breast and in lymph nodes, will be evaluated according to the criteria of Miller and Payne. Miller-Payne scale: Grade 1 No change or some alteration to individual malignant cell, but no reduction in overall cellularity Grade 2 A minor loss in tumor cells (up to 30%) Grade 3 Between an estimated 30 and 90% reduction in tumor cells Grade 4 Marked disappearance of tumor cells, with only small cluster or dispersed cell remaining (more than 90% loss) Grade 5 No malignant identifiable cells. DCIS may be present. ? To assess the safety profile, nature, incidence and severity of adverse events (AEs) and serious adverse events (SAEs) will be collected. Incidence of and reasons for study drug dose interruption or reduction and discontinuation will be collected ? The rate of conservative surgery will be calculated as the percent difference between the number of conservative surgical procedures feasible at study entry and the number of the conservative procedures performed after primary therapy ? The obje | — |
Countries
Italy
Outcome results
None listed