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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:	EUCTR2006-002600-33-IT
Date of registration:	13/06/2007
Prospective Registration:	No
Primary sponsor:	IBCSG
Public title:	Phase III trial of LHRH analog administration during chemotherapy to reduce ovarian failure following chemotherapy in early stage, hormone-receptor negative breast cancer. - ND
Scientific title:	Phase III trial of LHRH analog administration during chemotherapy to reduce ovarian failure following chemotherapy in early stage, hormone-receptor negative breast cancer. - ND
Date of first enrolment:	04/10/2006
Target sample size:	416
Recruitment status:	Not Recruiting
URL:	https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2006-002600-33
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: no Placebo: no Other: yes Other specify the comparator: NO TREATMENT
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:
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Email:
Affiliation:

Name:
Address:
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Key inclusion & exclusion criteria

Inclusion criteria:
Premenopausal women with histologically confirmed diagnosis of operable stage I, II or IIA invasive breast cancer. Patients who have completed surgery must have pathologic stage I, II or IIIA disease. Patients to be treated in the preoperative setting may be stage clinically but must have operable disease. Patients with bilateral synchronous invasive breast cancer diagnosed within a month of each other are eligible only if both primary tumors are hormone receptor negative. Tumors must be both estrogen and progesterone receptors negative. Patient's age 18-50 years
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
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion criteria:
No prior malignancy is allowed except for adequately treated basal or squamous cell skin cancer, is situ cancer or other cancer for which the patient has been disease free for 5 years after treatment with curative intent. Pregnant or nursing women. Prior cytotoxic chemotherapy for breast cancer or for any condition.

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

Health Condition(s) or Problem(s) studied

breast cancer
MedDRA version: 6.1 Level: PT Classification code 10057654

Intervention(s)

Trade Name: ZOLADEX 3,6*SC 1SIR DEPOT 3,6M
Product Name: GOSERELIN
Pharmaceutical Form: Implant
INN or Proposed INN: Goserelin
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 3.6-

Primary Outcome(s)

Primary end point(s): rate of ovarian failure at 2 years fron chemotherapy defined as amenorrhea for 6 months and FSH levels in the post-menopausal range

Main Objective: to compare the rate of premature ovarian failure at two years following standard adjuvant chemotherapy or neoadjuvant chemotherapy with or without the addition of ovarian suppression with a LHRH aqnalog during chemotherapy in premenopausal women with early stage, hormone-receptor negative breast cancer

Secondary Objective: to compare the rate of ovarian dysfunction at one and two years following standard adjuvant chemotherapy or neoadjuvant chemotherapy with or without ovarian suppression and to evaluate ovarian reserve in the 2 groups

Secondary Outcome(s)

Secondary ID(s)

2006-002600-33-BE

IBCSG 34-05/SWOG 0230

Source(s) of Monetary Support

Secondary Sponsor(s)

Ethics review

Status: Approved
Approval date: 04/10/2006
Contact:

Results

Results available:
Date Posted:
Date Completed:
URL:

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