Clinical Trials Register

Summary
EudraCT Number:	2020-003960-22
Sponsor's Protocol Code Number:	WOO2
National Competent Authority:	Austria - BASG
Clinical Trial Type:	EEA CTA
Trial Status:	Completed
Date on which this record was first entered in the EudraCT database:	2020-10-13
Trial results	View results

Index
A. PROTOCOL INFORMATION
B. SPONSOR INFORMATION
C. APPLICANT IDENTIFICATION
D. IMP IDENTIFICATION
D.8 INFORMATION ON PLACEBO
E. GENERAL INFORMATION ON THE TRIAL
F. POPULATION OF TRIAL SUBJECTS
G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
P. END OF TRIAL

Expand All Collapse All

A. Protocol Information

A.1

Member State Concerned

Austria - BASG

A.2

EudraCT number

2020-003960-22

A.3

Full title of the trial

Prospective Window of opportunity trial of 3 weeks neoadjuvant Anastrozole in Postmenopausal Women with Estrogen receptor positive (ER+) Breast Cancer

Prospektive Studie für 3-wöchentliches, neoadjuvantes Anastrozol bei postmenopausalen Frauen mit Östrogenrezepetor-positivem Brustkrebs

A.3.1

Title of the trial for lay people, in easily understood, i.e. non-technical, language

Prospective trial of 3 weeks neoadjuvant Anastrozole in Postmenopausal Women with Estrogen receptor positive (ER+) Breast Cancer

Prospektive Studie für neoadjuvantes Anastrozol bei postmenopausalen Frauen mit Östrogenrezepetor-positivem Brustkrebs

A.4.1

Sponsor's protocol code number

WOO2

A.7

Trial is part of a Paediatric Investigation Plan

A.8

EMA Decision number of Paediatric Investigation Plan

B. Sponsor Information
B.Sponsor: 1
B.1.1	Name of Sponsor	Medical University of Innsbruck
B.1.3.4	Country	Austria
B.3.1 and B.3.2	Status of the sponsor	Non-Commercial
B.4 Source(s) of Monetary or Material Support for the clinical trial:
B.4.1	Name of organisation providing support	EU Commission
B.4.2	Country	Austria
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	Medical University of Innsbruck
B.5.2	Functional name of contact point	PI
B.5.3	Address:
B.5.3.1	Street Address	Anichstraße 35
B.5.3.2	Town/ city	Innsbruck
B.5.3.3	Post code	6020
B.5.3.4	Country	Austria
B.5.6	E-mail	Daniel.Egle@tirol-kliniken.at

D. IMP Identification
D.IMP: 1
D.1.2 and D.1.3	IMP Role	Test
D.2	Status of the IMP to be used in the clinical trial
D.2.1	IMP to be used in the trial has a marketing authorisation	Yes
D.2.1.1.1	Trade name	Anastrozol
D.2.1.1.2	Name of the Marketing Authorisation holder	AstraZeneca
D.2.1.2	Country which granted the Marketing Authorisation	Austria
D.2.5	The IMP has been designated in this indication as an orphan drug in the Community	No
D.2.5.1	Orphan drug designation number
D.3 Description of the IMP
D.3.1	Product name	Anastrozol
D.3.4	Pharmaceutical form	Film-coated tablet
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Oral use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	ANASTROZOLE
D.3.9.1	CAS number	120511-73-1
D.3.9.3	Other descriptive name	Arimidex
D.3.9.4	EV Substance Code	SUB05502MIG
D.3.10	Strength
D.3.10.1	Concentration unit	mg milligram(s)
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	1
D.3.11 The IMP contains an:
D.3.11.1	Active substance of chemical origin	Yes
D.3.11.2	Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)	No
	The IMP is a:
D.3.11.3	Advanced Therapy IMP (ATIMP)	No
D.3.11.3.1	Somatic cell therapy medicinal product	No
D.3.11.3.2	Gene therapy medical product	No
D.3.11.3.3	Tissue Engineered Product	No
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	No
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	No
D.3.11.4	Combination product that includes a device, but does not involve an Advanced Therapy	No
D.3.11.5	Radiopharmaceutical medicinal product	No
D.3.11.6	Immunological medicinal product (such as vaccine, allergen, immune serum)	No
D.3.11.7	Plasma derived medicinal product	No
D.3.11.8	Extractive medicinal product	No
D.3.11.9	Recombinant medicinal product	No
D.3.11.10	Medicinal product containing genetically modified organisms	No
D.3.11.11	Herbal medicinal product	No
D.3.11.12	Homeopathic medicinal product	No
D.3.11.13	Another type of medicinal product	No

D.8 Information on Placebo

E. General Information on the Trial

E.1 Medical condition or disease under investigation

E.1.1

Medical condition(s) being investigated

(ER+) Breast Cancer

E.1.1.1

Medical condition in easily understood language

Hormone dependent breast cancer

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	23.0
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

E.1.3

Condition being studied is a rare disease

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

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.

E.2.3

Trial contains a sub-study

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 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)

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
• 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

E.5 End points

E.5.1

Primary end point(s)

kynurenine concentration

E.5.1.1

Timepoint(s) of evaluation of this end point

at day 1 and after 21 days treatment with Anastrozole

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

E.6 and E.7 Scope of the trial

E.6

Scope of the trial

E.6.1

Diagnosis

E.6.2

Prophylaxis

E.6.3

Therapy

E.6.4

Safety

E.6.5

Efficacy

E.6.6

Pharmacokinetic

Yes

E.6.7

Pharmacodynamic

Yes

E.6.8

Bioequivalence

E.6.9

Dose response

E.6.10

Pharmacogenetic

E.6.11

Pharmacogenomic

E.6.12

Pharmacoeconomic

E.6.13

Others

E.7

Trial type and phase

E.7.1

Human pharmacology (Phase I)

Yes

E.7.1.1

First administration to humans

E.7.1.2

Bioequivalence study

E.7.1.3

Other

Yes

E.7.1.3.1

Other trial type description

basic scientific research; Investigate biological effects of treatment in biological samples

E.7.2

Therapeutic exploratory (Phase II)

Yes

E.7.3

Therapeutic confirmatory (Phase III)

E.7.4

Therapeutic use (Phase IV)

E.8 Design of the trial

E.8.1

Controlled

E.8.1.1

Randomised

E.8.1.2

Open

Yes

E.8.1.3

Single blind

E.8.1.4

Double blind

E.8.1.5

Parallel group

E.8.1.6

Cross over

E.8.1.7

Other

E.8.2

Comparator of controlled trial

E.8.2.1

Other medicinal product(s)

E.8.2.2

Placebo

E.8.2.3

Other

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

E.8.5

The trial involves multiple Member States

E.8.6 Trial involving sites outside the EEA

E.8.6.1

Trial being conducted both within and outside the EEA

E.8.6.2

Trial being conducted completely outside of the EEA

E.8.7

Trial has a data monitoring committee

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

LVLS

E.8.9 Initial estimate of the duration of the trial

E.8.9.1

In the Member State concerned years

E.8.9.1

In the Member State concerned months

E.8.9.1

In the Member State concerned days

F. Population of Trial Subjects

F.1 Age Range

F.1.1

Trial has subjects under 18

F.1.1.1

In Utero

F.1.1.2

Preterm newborn infants (up to gestational age < 37 weeks)

F.1.1.3

Newborns (0-27 days)

F.1.1.4

Infants and toddlers (28 days-23 months)

F.1.1.5

Children (2-11years)

F.1.1.6

Adolescents (12-17 years)

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:

F.2 Gender

F.2.1

Female

Yes

F.2.2

Male

F.3 Group of trial subjects

F.3.1

Healthy volunteers

F.3.2

Patients

Yes

F.3.3

Specific vulnerable populations

F.3.3.1

Women of childbearing potential not using contraception

F.3.3.2

Women of child-bearing potential using contraception

F.3.3.3

Pregnant women

F.3.3.4

Nursing women

F.3.3.5

Emergency situation

F.3.3.6

Subjects incapable of giving consent personally

F.3.3.7

Others

F.4 Planned number of subjects to be included

F.4.1

In the member state

F.5

Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)

The treatment will be followed by the standard of care in respect to the postoperative tumor board recommendation.

G. Investigator Networks to be involved in the Trial

N. Review by the Competent Authority or Ethics Committee in the country concerned

Competent Authority Decision

Authorised

Date of Competent Authority Decision

2020-11-19

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2021-03-15

P. End of Trial
P.	End of Trial Status	Completed
P.	Date of the global end of the trial	2023-06-09

Select Country:	Select Age Range:
Select Trial Status:	Select Trial Phase:
Select Gender:
Select Date Range: to
Select Rare Disease:
IMP with orphan designation in the indication
Orphan Designation Number:
Results Status:
Clear advanced search filters

Austria
Belgium
Bulgaria
Croatia
Cyprus
Czechia
Denmark
Estonia
Finland
France
Germany
Greece
Hungary
Iceland
Ireland
Italy
Latvia
Liechtenstein
Lithuania
Luxembourg
Malta
Netherlands
Norway
Poland
Portugal
Romania
Slovakia
Slovenia
Spain
Sweden
United Kingdom
Outside EU/EEA

Clinical trials