E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
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E.1.1.1 | Medical condition in easily understood language |
Hormon dependent breast cancer |
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E.1.1.2 | Therapeutic area | Diseases [C] - Cancer [C04] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 20.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10070575 |
E.1.2 | Term | Estrogen receptor positive breast cancer |
E.1.2 | System Organ Class | 100000004864 |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
Comparison of kynurenine concentration before and after 21 days treatment with Anastrozole |
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E.2.2 | Secondary objectives of the trial |
• 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.
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal 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
• amenorrhea for 12 or more months
• 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)
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E.4 | Principal 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
• Participation in other clinical trials or observation period of competing trials, respectively
• missing written informed consent
• missing understanding of German language
• Previously included in this trial (no patient may be included more than once)
• Current infection of any kind
• Inflammation including autoimmune disease and active allergy
• Breast feeding
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E.5 End points |
E.5.1 | Primary end point(s) |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
at day 1 and after 21 days treatment with Anastrozole |
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E.5.2 | 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
|
|
E.5.2.1 | Timepoint(s) of evaluation of this end point |
• from baseline and after 3 weeks of treatment with Anastrozole |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | No |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | Yes |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | No |
E.8.1.1 | Randomised | No |
E.8.1.2 | Open | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | No |
E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 4 |
E.8.9.1 | In the Member State concerned months | 9 |
E.8.9.1 | In the Member State concerned days | |