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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:	EUCTR2005-003434-18-IT
Date of registration:	30/11/2006
Prospective Registration:	No
Primary sponsor:	IBCSG
Public title:	Phase III Trial Evaluating the Role of Adjuvant Pegylated Liposomal Doxorubicin PLD, Caelyx, Doxil for Women age 66 years or older with Endocrine Nonresponsive Breast Cancer Who Are NOT Suitable for Being Offered a Standard Chemotherapy Regimen
Scientific title:	Phase III Trial Evaluating the Role of Adjuvant Pegylated Liposomal Doxorubicin PLD, Caelyx, Doxil for Women age 66 years or older with Endocrine Nonresponsive Breast Cancer Who Are NOT Suitable for Being Offered a Standard Chemotherapy Regimen
Date of first enrolment:	27/12/2005
Target sample size:	1300
Recruitment status:	Not Recruiting
URL:	https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2005-003434-18
Study type:	Interventional clinical trial of medicinal product
Study design:	Controlled: yes 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: yes Placebo: no Other: no
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	France	Hungary	Italy	Slovenia	Sweden

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:
F.1.2 Adults (18-64 years) no
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

Endocrine Nonresponsive Breast Cancer in Women age 66 years or older Who Are NOT Suitable for Being Offered a Standard Chemotherapy Regimen
MedDRA version: 8.1 Level: PT Classification code 10057654 Term: Breast cancer female

Intervention(s)

Trade Name: CAELYX*INFUS 1FL 2MG/ML 25ML
Pharmaceutical Form: Solution for infusion
INN or Proposed INN: Doxorubicin
CAS Number: 25316-40-9
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 2-

Trade Name: ENDOXAN BAXTER*50CPR RIV 50MG
Pharmaceutical Form: Tablet
INN or Proposed INN: Cyclophosphamide
CAS Number: 6055-19-2
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 50-

Trade Name: METHOTREXATE*25CPR 2,5MG
Pharmaceutical Form: Tablet
INN or Proposed INN: Methotrexate
CAS Number: 6055-19-2
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 2.5-

Primary Outcome(s)

Secondary Objective:

Primary end point(s):

Main Objective:

Secondary Outcome(s)

Secondary ID(s)

IBCSG 32-05

2005-003434-18-SE

Source(s) of Monetary Support

Secondary Sponsor(s)

Ethics review

Status: Approved
Approval date: 07/09/2005
Contact:

Results

Results available:	Yes
Date Posted:	17/03/2021
Date Completed:	31/12/2011
URL:	https://www.clinicaltrialsregister.eu/ctr-search/trial/2005-003434-18/results

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