(ER+) Breast Cancer MedDRA version: 23.0 Level: LLT Classification code 10070575 Term: Estrogen receptor positive breast cancer System Organ Class: 100000004864
Conditions
Sponsors
Medical University of Innsbruck
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Ability of subject to understand character and individual consequences of clinical trial • postmenopausal women, postmenopausal status is defined either by: • Prior bilateral oophorectomy or • amenorrhea for 12 or more months • only women that receive an aromatase inhibitor as their standard treatment after surgery will be eligible for the Trial • ER+, breast cancer, first diagnosed • breast cancers with a tumor size >/= cT1c. • Not legally incapacitated • Written informed consent (must be available before enrolment in the trial) 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 40 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 10
Exclusion criteria
Exclusion criteria: • prior breast cancer specific therapy • inflammatory cancers • Any medical condition (e.g. substance abuse) that may, in the clinical judgement of the investigator, independently influence the subject’s outcome during this study • known hypersensitivity to anastrozole or to any of the excipients • Participation in other clinical trials using investigational drug planned, during the active treatment phase • Not being able to comprehend the German language • Previously included in this trial (no patient may be included more than once) • Current infection of any kind, at the time of treatment start • Inflammation including autoimmune disease and active allergy • Breast feeding • Pregnancy • Osteoporosis • Severe hepatic or renal impairment
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Comparison of kynurenine concentration before and after 21 days treatment with Anastrozole ;Secondary Objective: • Association between MESI networks & marker panels and biological/pathological responses • percent change in Ki67 expression from baseline to the surgical tissue 3 weeks after the start of treatment with Anastrozole; • effect of Anastrozole on peripheral blood mononuclear cells (PBMC) • clinical response of the breast tumor to therapy as assessed by histopathology; • response of the breast tumor as evaluated by ultrasound assessment before surgery and after 3 weeks of treatment with Anastrozole. ;Primary end point(s): kynurenine concentration ;Timepoint(s) of evaluation of this end point: at day 1 and after 21 days treatment with Anastrozole | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): • association between MESI networks & marker panels and biological/pathological responses • percent change in Ki67 expression from baseline to the surgical tissue after 3 weeks of treatment with Anastrozole • effect of Anastrozole on peripheral blood mononuclear cells (PBMC) • clinical response of the breast tumor to therapy as assessed by histopathology at EOS • response of the breast tumor as evaluated by ultrasound assessment before surgery after 3 weeks of treatment with Anastrozole ;Timepoint(s) of evaluation of this end point: • from baseline and after 3 weeks of treatment with Anastrozole | — |
Countries
Austria
Contacts
Public ContactPI
Medical University of Innsbruck
Outcome results
None listed