Invasive Breast Cancer, tumor size >= 1 cm (NOT inflammatory breast cancer), no clues of metastatic disease, no multicentric breast cancer
Conditions
Interventions
Pharmaceutical Form: Tablet
INN or Proposed INN: ANASTROZOLE
CAS Number: 120511731
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 1-
Pharmaceutical Form: Tablet
I
Sponsors
NKI-AVL
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Patients with proven invasive adenocarcinoma of the breast • Any tumor with a size = 1cm (NOT inflammatory breast cancer) • WHO-performance score 0 or 1 • Written informed consent 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: • Clues of metastatic disease by clinical examination according to most recent NABON guidelines • Multicentric breast cancer • Inflammatory breast cancer • Hormone replacement during the last 12 months • Already planned date for surgery within the next 2 weeks • Any psychological, familial, sociological or geographical condition potentially hampering adequate informed consent or compliance with the study protocol • Patient’s refusal to undergo a core biopsy procedure of the primary tumor before the start of treatment NB: a concomitant malignancy within the last five years is not an exclusion criterium, because survival is not the primary endpoint. Just as prior invasive breast cancer or DCIS within the last 15 years is not an exclusion criterium.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To investigate prospectively how the "TAMRO-profile" performs in a pre-operative treatment setting. And to investigate the correlation between phospho-PKA in combination with phospho-Serine305 and tamoxifen resistance.;Secondary Objective: • Comparison of changes in gene expression after different endocrine treatment exposures • Correlation of SNPs in CYP450 sequences with drug toxicity and downregulation of Ki67 • Change in ER expression after different treatment regimens • Correlation of gene and protein expression patterns with DFS (after 5 years and 10 years) • To assess a clinical response/ size reduction the (reduction in) size will be documented by palpation. ;Primary end point(s): Primary endpoints are change in tumor cell proliferation and induced apoptosis. These parameters will be measured on sequential baseline and surgical samples: proliferation by (change in) Ki67 expression and Cyclin A, apoptosis by the TUNEL assay. Drug induced changes in gene expression profile will be correlated with the immunohistochemical parameters. | — |
Countries
Netherlands
Outcome results
None listed