Flag of the European Union

EU Clinical Trials Register

Help

Clinical trials

The European Union Clinical Trials Register allows you to search for protocol and results information on:

interventional clinical trials that were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC

clinical trials conducted outside the EU/EEA that are linked to European paediatric-medicine development

EU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly accessible through the
Clinical Trials Information System (CTIS).

The EU Clinical Trials Register currently displays 43871 clinical trials with a EudraCT protocol, of which 7290 are clinical trials conducted with subjects less than 18 years old. The register also displays information on 18700 older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

Phase 1 trials conducted solely on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).

Examples: Cancer AND drug name. Pneumonia AND sponsor name.
How to search [pdf]

Advanced Search:

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

< Back to search results

Clinical Trial Results:
Phase III trial of LHRH analog administration during chemotherapy to reduce ovarian failure following chemotherapy in early stage, hormone-receptor negative breast cancer.

Summary
EudraCT number	2006-002600-33
Trial protocol	BE IT HU
Global end of trial date	20 Jan 2017

Results information
Results version number	v1(current)
This version publication date	15 Dec 2022
First version publication date	15 Dec 2022
Other versions

Trial Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information

Collapse all Expand all

Trial information

Top of page

Sponsor protocol code

IBCSG 34-05/SWOG 0230/ POEMS

ISRCTN number

-

US NCT number

NCT00068601

WHO universal trial number (UTN)

-

Sponsor organisation name

IBCSG

Sponsor organisation address

Effingerstrasse 40, Bern, Switzerland, 3008

Public contact

IBCSG Coordinating Center, International Breast Cancer Study Group (IBCSG), +41 31 511 94 00, regulatoryoffice@ibcsg.org

Scientific contact

IBCSG Coordinating Center, International Breast Cancer Study Group (IBCSG), +41 31 511 94 00, regulatoryoffice@ibcsg.org

Is trial part of an agreed paediatric investigation plan (PIP)

No

Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?

No

Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?

No

Analysis stage

Interim

Date of interim/final analysis

22 Jan 2014

Is this the analysis of the primary completion data?

Yes

Primary completion date

22 Jan 2014

Global end of trial reached?

Yes

Global end of trial date

20 Jan 2017

Was the trial ended prematurely?

Yes

Main objective of the trial

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 analog during chemotherapy in premenopausal women with early stage, hormone-receptor negative breast cancer

Protection of trial subjects

Participating institutions’ ethics committees or Institutional Review Boards approved the trial according to local laws and regulations. All patients gave written informed consent, and the trial was performed in compliance with the Helsinki Declaration. The Data Safety and Monitoring Board reviewed the data from this research throughout the study.

Background therapy

-

Evidence for comparator

-

Actual start date of recruitment

13 Feb 2004

Long term follow-up planned

Yes

Long term follow-up rationale

Safety, Efficacy

Long term follow-up duration

5 Years

Independent data monitoring committee (IDMC) involvement?

Yes

Number of subjects enrolled per country

Country: Number of subjects enrolled

Hungary: 31

Country: Number of subjects enrolled

Italy: 8

Country: Number of subjects enrolled

Australia: 37

Country: Number of subjects enrolled

New Zealand: 21

Country: Number of subjects enrolled

United States: 152

Country: Number of subjects enrolled

Canada: 1

Country: Number of subjects enrolled

Switzerland: 7

Worldwide total number of subjects

257

EEA total number of subjects

39

Number of subjects enrolled per age group

In utero

0

Preterm newborn - gestational age < 37 wk

0

Newborns (0-27 days)

0

Infants and toddlers (28 days-23 months)

0

Children (2-11 years)

0

Adolescents (12-17 years)

0

Adults (18-64 years)

257

From 65 to 84 years

0

85 years and over

0

Subject disposition

Top of page

Recruitment details

A total of 257 patients were randomized between February 2004 and May 2011.

Screening details

The trial used a web-based randomization system.

Period 1 title

Overall Study

Is this the baseline period?

No

Allocation method

Randomised - controlled

Blinding used

Not blinded

Are arms mutually exclusive

No

Arm 1

Arm description

Patients receive cyclophosphamide-containing chemotherapy alone. cyclophosphamide: Part of planned chemotherapy regimen

Arm type

Active comparator

Investigational medicinal product name

cyclophosphamide

Investigational medicinal product code

Other name

Pharmaceutical forms

Powder for solution for injection/infusion

Routes of administration

Intravenous use

Dosage and administration details

The patient's planned treatment must include 3 to 8 months or cycles of an alkylating agent containing post-operative or pre-operative chemotherapy regimen that can be anthracycline-based or non-anthracycline-based. Examples of anthracycline-based regimens include: AC (3 months or 4 cycles), CAF (6 months/cycles), TAC (6 months/cycles), CEF (6 months/cycles), and AC followed by a taxane (6 to 8 months or cycles). An example of non-anthracycline-based regimen is CMF (6 months).

Arm 2

Arm description

Patients receive goserelin subcutaneously once every 4 weeks beginning 1 week before start of cyclophosphamide-containing chemotherapy. Treatment continues until completion of chemotherapy in the absence of disease progression or unacceptable toxicity. cyclophosphamide: Part of planned chemotherapy regimen goserelin acetate: Given subcutaneously

Arm type

Experimental

Investigational medicinal product name

goserelin acetate

Investigational medicinal product code

Other name

Pharmaceutical forms

Implant

Routes of administration

Subcutaneous use

Dosage and administration details

Goserelin acetate, 3.6 mg implant. Goserelin is administered once every 4 weeks for duration of chemotherapy

Number of subjects in period 1	Arm 1	Arm 2
Started	131	126
Completed	69	66
Not completed	62	60
Ineligible	11	13
Consent withdrawn by subject	5	4
Missing primary outcome data	30	34
Death	11	3
Lost to Follow-up	3	2
Not evaluable: hysterectomy/oophorectomy	2	4

Period 2 title

ITT analysis

Is this the baseline period?

Yes ^[1]

Allocation method

Randomised - controlled

Blinding used

Not blinded

Are arms mutually exclusive

Yes

Arm 1

Arm description

Patients receive cyclophosphamide-containing chemotherapy alone. cyclophosphamide: Part of planned chemotherapy regimen

Arm type

Active comparator

Investigational medicinal product name

cyclophosphamide

Investigational medicinal product code

Other name

Pharmaceutical forms

Powder for solution for injection/infusion

Routes of administration

Intravenous use

Dosage and administration details

The patient's planned treatment must include 3 to 8 months or cycles of an alkylating agent containing post-operative or pre-operative chemotherapy regimen that can be anthracycline-based or non-anthracycline-based. Examples of anthracycline-based regimens include: AC (3 months or 4 cycles), CAF (6 months/cycles), TAC (6 months/cycles), CEF (6 months/cycles), and AC followed by a taxane (6 to 8 months or cycles). An example of non-anthracycline-based regimen is CMF (6 months).

Arm 2

Arm description

Patients receive goserelin subcutaneously once every 4 weeks beginning 1 week before start of cyclophosphamide-containing chemotherapy. Treatment continues until completion of chemotherapy in the absence of disease progression or unacceptable toxicity. cyclophosphamide: Part of planned chemotherapy regimen goserelin acetate: Given subcutaneously

Arm type

Experimental

Investigational medicinal product name

goserelin acetate

Investigational medicinal product code

Other name

Pharmaceutical forms

Implant

Routes of administration

Subcutaneous use

Dosage and administration details

Goserelin acetate, 3.6 mg implant. Goserelin is administered once every 4 weeks for duration of chemotherapy

Notes
[1] - Period 1 is not the baseline period. It is expected that period 1 will be the baseline period.
Justification: Baseline characteristics were only reported for Intention-to-treat population

Number of subjects in period 2 ^[2]	Arm 1	Arm 2
Started	113	105
Completed	113	105

Notes
[2] - The number of subjects reported to be in the baseline period are not the same as the worldwide number enrolled in the trial. It is expected that these numbers will be the same.
Justification: Intention-to-treat population excludes 24 pts that were ineligible, 9 pts that withdrew consent and 6 pts that were not evaluable due to hysterectomy/oophorectomy

Baseline characteristics

Top of page

Reporting group title

Arm 1

Reporting group description

Patients receive cyclophosphamide-containing chemotherapy alone. cyclophosphamide: Part of planned chemotherapy regimen

Reporting group title

Arm 2

Reporting group description

Patients receive goserelin subcutaneously once every 4 weeks beginning 1 week before start of cyclophosphamide-containing chemotherapy. Treatment continues until completion of chemotherapy in the absence of disease progression or unacceptable toxicity. cyclophosphamide: Part of planned chemotherapy regimen goserelin acetate: Given subcutaneously

Reporting group values	Arm 1	Arm 2	Total
Number of subjects	113	105	218
Age categorical
Units: Subjects
In utero	0	0	0
Preterm newborn infants (gestational age < 37 wks)	0	0	0
Newborns (0-27 days)	0	0	0
Infants and toddlers (28 days-23 months)	0	0	0
Children (2-11 years)	0	0	0
Adolescents (12-17 years)	0	0	0
Adults (18-64 years)	0	0	0
From 65-84 years	113	105	218
85 years and over	0	0	0
Years	0	0	0
Age continuous
Number analyzed
Units: years
median (full range (min-max))	38.7 (25.1 to 49.9)	37.6 (26.1 to 48.6)	-
Gender categorical
Units: Subjects
Female	113	105	218
Male	0	0	0

Subject analysis set title

Overall Number of Baseline Participants

Subject analysis set type

Full analysis

Subject analysis set description

Patients who are both eligible and evaluable

Subject analysis sets values	Overall Number of Baseline Participants
Number of subjects	218
Age categorical
Units: Subjects
In utero	0
Preterm newborn infants (gestational age < 37 wks)	0
Newborns (0-27 days)	0
Infants and toddlers (28 days-23 months)	0
Children (2-11 years)	0
Adolescents (12-17 years)	0
Adults (18-64 years)	0
From 65-84 years	218
85 years and over	0
Years	0
Age continuous
Number analyzed
Units: years
median (full range (min-max))	37.7 (25.1 to 49.9)
Gender categorical
Units: Subjects
Female	218
Male	0

End points

Top of page

Reporting group title

Arm 1

Reporting group description

Patients receive cyclophosphamide-containing chemotherapy alone. cyclophosphamide: Part of planned chemotherapy regimen

Reporting group title

Arm 2

Reporting group description

Patients receive goserelin subcutaneously once every 4 weeks beginning 1 week before start of cyclophosphamide-containing chemotherapy. Treatment continues until completion of chemotherapy in the absence of disease progression or unacceptable toxicity. cyclophosphamide: Part of planned chemotherapy regimen goserelin acetate: Given subcutaneously

Reporting group title

Arm 1

Reporting group description

Patients receive cyclophosphamide-containing chemotherapy alone. cyclophosphamide: Part of planned chemotherapy regimen

Reporting group title

Arm 2

Reporting group description

Patients receive goserelin subcutaneously once every 4 weeks beginning 1 week before start of cyclophosphamide-containing chemotherapy. Treatment continues until completion of chemotherapy in the absence of disease progression or unacceptable toxicity. cyclophosphamide: Part of planned chemotherapy regimen goserelin acetate: Given subcutaneously

Subject analysis set title

Overall Number of Baseline Participants

Subject analysis set type

Full analysis

Subject analysis set description

Patients who are both eligible and evaluable

Primary: Rate of Premature Ovarian Failure at 2 Years

Top of page

End point title

Rate of Premature Ovarian Failure at 2 Years

End point description

Ovarian failure at two years is defined as amenorrhea (absence of menstrual bleeding) for the preceding six months AND the presence of follicle-stimulating hormone (FSH) in the post-menopausal range.

End point type

Primary

End point timeframe

2 years

End point values	Arm 1	Arm 2
Number of subjects analysed	69	66
Units: Participants	15	5

stratified logistic-regression analysis

Comparison groups

Arm 2 v Arm 1

Number of subjects included in analysis

135

Analysis specification

Pre-specified

Analysis type

P-value

= 0.04

Method

t-test, 2-sided

Parameter type

Odds ratio (OR)

Point estimate

0.3

Confidence interval

level

95%

sides

2-sided

lower limit

0.09

upper limit

0.97

Adverse events

Top of page

Timeframe for reporting adverse events

Only adverse events related to hormonal effects and serious adverse events that occurred during chemotherapy with or without goserelin were routinely assessed, with assessment according to the Common Terminology Criteria for Adverse Events, version 3

Assessment type

Systematic

Dictionary name

CTCAE

Dictionary version

3.0

Reporting group title

Arm 1

Reporting group description

Patients receive cyclophosphamide-containing chemotherapy alone. cyclophosphamide: Part of planned chemotherapy regimen

Reporting group title

Arm 2

Reporting group description

Patients receive goserelin subcutaneously once every 4 weeks beginning 1 week before start of cyclophosphamide-containing chemotherapy. Treatment continues until completion of chemotherapy in the absence of disease progression or unacceptable toxicity. cyclophosphamide: Part of planned chemotherapy regimen goserelin acetate: Given subcutaneously

Serious adverse events	Arm 1	Arm 2
Total subjects affected by serious adverse events
subjects affected / exposed	9 / 111 (8.11%)	4 / 103 (3.88%)
number of deaths (all causes)	17	8
number of deaths resulting from adverse events	0	0
Gastrointestinal disorders
Diarrhea G3
subjects affected / exposed	0 / 111 (0.00%)	1 / 103 (0.97%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Abdominal pain and fever
subjects affected / exposed	1 / 111 (0.90%)	0 / 103 (0.00%)
occurrences causally related to treatment / all	1 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Infections and infestations
Febrile neutropenia
subjects affected / exposed	5 / 111 (4.50%)	3 / 103 (2.91%)
occurrences causally related to treatment / all	7 / 7	1 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
Septic shock
subjects affected / exposed	0 / 111 (0.00%)	1 / 103 (0.97%)
occurrences causally related to treatment / all	0 / 0	1 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Infection with normal ANC
subjects affected / exposed	1 / 111 (0.90%)	0 / 103 (0.00%)
occurrences causally related to treatment / all	1 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Infection with Grade 3 or 4 neutrophils - catheter related
subjects affected / exposed	1 / 111 (0.90%)	0 / 103 (0.00%)
occurrences causally related to treatment / all	1 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Infection prothesis site R breast
subjects affected / exposed	1 / 111 (0.90%)	0 / 103 (0.00%)
occurrences causally related to treatment / all	1 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0

Frequency threshold for reporting non-serious adverse events: 1%

Non-serious adverse events	Arm 1	Arm 2
Total subjects affected by non serious adverse events
subjects affected / exposed	27 / 111 (24.32%)	50 / 103 (48.54%)
Vascular disorders
Hot flashes
subjects affected / exposed	17 / 111 (15.32%)	33 / 103 (32.04%)
occurrences all number	17	33
Thromboembolism
subjects affected / exposed	0 / 111 (0.00%)	1 / 103 (0.97%)
occurrences all number	0	1
Nervous system disorders
Headache
subjects affected / exposed	2 / 111 (1.80%)	12 / 103 (11.65%)
occurrences all number	2	12
General disorders and administration site conditions
Fatigue
subjects affected / exposed	1 / 111 (0.90%)	2 / 103 (1.94%)
occurrences all number	1	2
Gastrointestinal disorders
Diarrhea
subjects affected / exposed	2 / 111 (1.80%)	0 / 103 (0.00%)
occurrences all number	2	0
Reproductive system and breast disorders
Irregular menses
subjects affected / exposed	2 / 111 (1.80%)	7 / 103 (6.80%)
occurrences all number	2	7
Vaginal dryness
subjects affected / exposed	9 / 111 (8.11%)	12 / 103 (11.65%)
occurrences all number	9	12
Skin and subcutaneous tissue disorders
Sweating
subjects affected / exposed	7 / 111 (6.31%)	10 / 103 (9.71%)
occurrences all number	7	10
Psychiatric disorders
Decrease in libido
subjects affected / exposed	6 / 111 (5.41%)	9 / 103 (8.74%)
occurrences all number	6	9
Agitation
subjects affected / exposed	5 / 111 (4.50%)	6 / 103 (5.83%)
occurrences all number	5	6
Anxiety
subjects affected / exposed	4 / 111 (3.60%)	9 / 103 (8.74%)
occurrences all number	4	9
Depression
subjects affected / exposed	3 / 111 (2.70%)	9 / 103 (8.74%)
occurrences all number	3	9
Musculoskeletal and connective tissue disorders
Joint pain
subjects affected / exposed	2 / 111 (1.80%)	0 / 103 (0.00%)
occurrences all number	2	0
Muscle pain
subjects affected / exposed	2 / 111 (1.80%)	1 / 103 (0.97%)
occurrences all number	2	1

More information

Top of page

Were there any global substantial amendments to the protocol? Yes

15 Dec 2010

Inclusion of eligibility data on the Prestudy Form

Were there any global interruptions to the trial? No

Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.

None

http://www.ncbi.nlm.nih.gov/pubmed/25738668

For support, Contact us.

The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

European Medicines Agency © 1995-Sun May 05 13:18:49 CEST 2024 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands