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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.

Register:	EUCTR
Last refreshed on:	21 December 2021
Main ID:	EUCTR2005-001893-28-IT
Date of registration:	26/04/2007
Prospective Registration:	No
Primary sponsor:	IBCSG
Public title:	A RANDOMIZED PHASE III TRIAL OF EXEMESTANE VERSUS ANASTROZOLE IN POSTMENOPAUSAL WOMEN WITH RECEPTOR POSITIVE PRIMARY BREAST CANCER
Scientific title:	A RANDOMIZED PHASE III TRIAL OF EXEMESTANE VERSUS ANASTROZOLE IN POSTMENOPAUSAL WOMEN WITH RECEPTOR POSITIVE PRIMARY BREAST CANCER
Date of first enrolment:	20/09/2005
Target sample size:	170
Recruitment status:	Not Recruiting
URL:	https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2005-001893-28
Study type:	Interventional clinical trial of medicinal product
Study design:	Controlled: no Randomised: yes Open: yes Single blind: no Double blind: no Parallel group: yes Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: Placebo: Other: Number of treatment arms in the trial: 2
Phase:	Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): no Therapeutic confirmatory - (Phase III): yes Therapeutic use (Phase IV): no

Countries of recruitment
Belgium	Hungary	Italy

Contacts

Name:
Address:
Telephone:
Email:
Affiliation:

Name:
Address:
Telephone:
Email:
Affiliation:

Key inclusion & exclusion criteria

Inclusion criteria:
Are the trial subjects under 18? no
Number of subjects for this age range: 0
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:

Age minimum:
Age maximum:
Gender:
Female: yes
Male: no

Health Condition(s) or Problem(s) studied

HORMONE RESPONSIVE BREAST CANCER IN POST MENOPAUSAL WOMEN
MedDRA version: 14.1 Level: PT Classification code 10057654 Term: Breast cancer female System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Therapeutic area: Diseases [C] - Cancer [C04]

Intervention(s)

Trade Name: AROMASIN*30CPR RIV 25MG
Pharmaceutical Form: Coated tablet
INN or Proposed INN: Exemestane
CAS Number: 107868-30-4
Concentration unit: mg milligram(s)
Concentration number: 25-

Trade Name: ARIMIDEX*28CPR 1MG
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: Anastrozole
CAS Number: 120511-73-1
Concentration unit: mg milligram(s)
Concentration number: 1-

Primary Outcome(s)

Main Objective:

Secondary Objective:

Primary end point(s):

Secondary Outcome(s)

Secondary ID(s)

IBCSG30-04

2005-001893-28-HU

Source(s) of Monetary Support

Secondary Sponsor(s)

Ethics review

Status: Approved
Approval date: 25/05/2005
Contact:

Results

Results available:	Yes
Date Posted:	07/02/2020
Date Completed:	31/10/2013
URL:	https://www.clinicaltrialsregister.eu/ctr-search/trial/2005-001893-28/results

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