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Clinical Trial Results:
Evaluation de l'efficacité et de la tolérance du Lanreotide LP 90 mg versus placebo dans la diminution de la lyphorrhée post curage axillaire dans les cancers du sein.

Summary
EudraCT number	2007-003576-19
Trial protocol	FR
Global end of trial date	23 Jun 2011

Results information
Results version number	v1(current)
This version publication date	01 Jun 2021
First version publication date	01 Jun 2021
Other versions
Summary report(s)	2007-003576-19_results

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

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Trial information

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Sponsor protocol code

I07015

ISRCTN number

US NCT number

NCT00630695

WHO universal trial number (UTN)

Sponsor organisation name

CHU de Limoges

Sponsor organisation address

2 Avenue Martin Luther King, Limoges, France, 87042

Public contact

Pr Yves AUBARD, CHU de lImoges, 33 550552109, yves.aubard@unilim.fr

Scientific contact

Pr Yves AUBARD, CHU de lImoges, 33 550552109, yves.aubard@unilim.fr

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

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

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

Analysis stage

Final

Date of interim/final analysis

23 Jun 2011

Is this the analysis of the primary completion data?

Global end of trial reached?

Yes

Global end of trial date

23 Jun 2011

Was the trial ended prematurely?

Main objective of the trial

To assess the efficacy of Lanreotide Autogel 90 mg PR to prevent lymphorrhea after axillary dissection in breast cancer.

Protection of trial subjects

The study was in compliance with the ethical principles derived from the Declaration of Helsinki and in compliance with all International Conference on Harmonization (ICH) Good Clinical Practice (GCP) Guidelines. All the local regulatory requirements pertinent to safety of trial subjects were followed. The patients were included after transparent information on the interests and risks associated with the research. Consent was systematically obtained after information, answers to patients' questions and a period of reflection. In addition to the scheduled visits, patients were invited to contact the service before these visits, in case of problems, regardless of the date, especially in the event of the appearance of painful axillary effusion or the appearance of side effects of treatment (diarrhea, abdominal pain ...).

Background therapy

Evidence for comparator

Actual start date of recruitment

01 Apr 2008

Long term follow-up planned

Independent data monitoring committee (IDMC) involvement?

Number of subjects enrolled per country

Country: Number of subjects enrolled

France: 147

Worldwide total number of subjects

147

EEA total number of subjects

147

Number of subjects enrolled per age group

In utero

Preterm newborn - gestational age < 37 wk

Newborns (0-27 days)

Infants and toddlers (28 days-23 months)

Children (2-11 years)

Adolescents (12-17 years)

Adults (18-64 years)

133

From 65 to 84 years

85 years and over

Subject disposition

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Recruitment details

All patients were recruited at CHU limoges Hospital between april 2008 and december 2010.

Screening details

Eligibility criteria: the patients included were over-18- year-old women with breast cancer who had to undergo axillary lymph node dissection (AD) either alone or with either lumpectomy or mastectomy. Exclusion criteria were diabetes mellitus with insulinotherapy, cyclosporin treatment, kidney failure and pregnancy. T

Period 1 title

Overall trial (overall period)

Is this the baseline period?

Yes

Allocation method

Randomised - controlled

Blinding used

Double blind

Roles blinded

Subject, Investigator

Blinding implementation details

Treatment group received one deep subcutaneous (sc) 0.3 ml injection of Lanreotide Autogel 90 mg PR (Somatuline)) and the control group received one sc injection of 0.3 ml saline preparation using the same protocol. Because lanreotide and placebo look different, only the nurse who gave the injection knew what was injected. This nurse was excluded from both patient follow up and data measurements.

Are arms mutually exclusive

Yes

LANREOTIDE

Arm description

In this expirimental group, patients received one deep subcutaneous (sc) 0.3 ml injection of Lanreotide Autogel 90 mg PR (Somatuline)

Arm type

Experimental

Investigational medicinal product name

LANREOTIDE

Investigational medicinal product code

Other name

Somatoline

Pharmaceutical forms

Injection

Routes of administration

Subcutaneous use

Dosage and administration details

0.3 ml injection of Lanreotide Autogel 90 mg PR

Placebo

Arm description

Placebo group received one sc injection of 0.3 ml saline preparation

Arm type

Placebo

Investigational medicinal product name

Placebo

Investigational medicinal product code

Other name

Pharmaceutical forms

Solution for injection

Routes of administration

Subcutaneous use

Dosage and administration details

One sc injection of 0.3 ml saline preparation

Number of subjects in period 1	LANREOTIDE	Placebo
Started	73	74
Completed	72	73
Not completed	1	1
Protocol deviation	1	1

Baseline characteristics

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Reporting group title

LANREOTIDE

Reporting group description

In this expirimental group, patients received one deep subcutaneous (sc) 0.3 ml injection of Lanreotide Autogel 90 mg PR (Somatuline)

Reporting group title

Placebo

Reporting group description

Placebo group received one sc injection of 0.3 ml saline preparation

Reporting group values	LANREOTIDE	Placebo	Total
Number of subjects	73	74	147
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)	68	65	133
From 65-84 years	4	8	12
85 years and over	1	1	2
Gender categorical
Units: Subjects
Female	73	74	147
Male	0	0	0

End points

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Reporting group title

LANREOTIDE

Reporting group description

In this expirimental group, patients received one deep subcutaneous (sc) 0.3 ml injection of Lanreotide Autogel 90 mg PR (Somatuline)

Reporting group title

Placebo

Reporting group description

Placebo group received one sc injection of 0.3 ml saline preparation

Primary: Postoperative lymphorrhea volume

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End point title

Postoperative lymphorrhea volume

End point description

End point type

Primary

End point timeframe

At day 4 postoperative

End point values	LANREOTIDE	Placebo
Number of subjects analysed	72	73
Units: Volume
arithmetic mean (standard deviation)	330 ± 182	383 ± 230

Mann Whitney test

Comparison groups

LANREOTIDE v Placebo

Number of subjects included in analysis

145

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.18 ^[1]

Method

Wilcoxon (Mann-Whitney)

Confidence interval

Notes
[1] - Not statistically significant ( p= 0.18).

Secondary: Postoperative reduction of lymphorrhea volume

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End point title

Postoperative reduction of lymphorrhea volume

End point description

End point type

Secondary

End point timeframe

At 15 day postoperative

End point values	LANREOTIDE	Placebo
Number of subjects analysed	70	71
Units: Volume(ml)
number (not applicable)	317.5	407

Mann Whitney test.

Comparison groups

LANREOTIDE v Placebo

Number of subjects included in analysis

141

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.26

Method

Wilcoxon (Mann-Whitney)

Confidence interval

Secondary: Postoperative reduction of lymphorrhea volume

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End point title

Postoperative reduction of lymphorrhea volume

End point description

End point type

Secondary

End point timeframe

At 30 day posteoperative

End point values	LANREOTIDE	Placebo
Number of subjects analysed	68	69
Units: Volume (ml)
number (not applicable)	327.5	407

Mann Whitney test.

Comparison groups

LANREOTIDE v Placebo

Number of subjects included in analysis

137

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.26

Method

Wilcoxon (Mann-Whitney)

Confidence interval

Secondary: Postoperative reduction of lymphorrhea volume

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End point title

Postoperative reduction of lymphorrhea volume

End point description

End point type

Secondary

End point timeframe

At 180 days posteoperative

End point values	LANREOTIDE	Placebo
Number of subjects analysed	62	63
Units: Volume (ml)
number (not applicable)	317.5	403

Mann Whitney test.

Comparison groups

LANREOTIDE v Placebo

Number of subjects included in analysis

125

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.2

Method

Wilcoxon (Mann-Whitney)

Confidence interval

Adverse events

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Timeframe for reporting adverse events

Adverse events were assessed fron inclusion til 30 days after treatment injection.

Assessment type

Systematic

Dictionary name

MedDRA

Dictionary version

14.0

Reporting group title

Overall trial

Reporting group description

Serious adverse events	Overall trial
Total subjects affected by serious adverse events
subjects affected / exposed	18 / 147 (12.24%)
number of deaths (all causes)	2
number of deaths resulting from adverse events	2
Injury, poisoning and procedural complications
Phlebitis
subjects affected / exposed	1 / 147 (0.68%)
occurrences causally related to treatment / all	0 / 1
deaths causally related to treatment / all	0 / 0
Vascular disorders
Subclavian vein thrombosis
subjects affected / exposed	1 / 147 (0.68%)
occurrences causally related to treatment / all	0 / 1
deaths causally related to treatment / all	0 / 0
Pulmonary embolism
subjects affected / exposed	1 / 147 (0.68%)
occurrences causally related to treatment / all	0 / 1
deaths causally related to treatment / all	0 / 0
Hemorrhage
subjects affected / exposed	1 / 147 (0.68%)
occurrences causally related to treatment / all	0 / 1
deaths causally related to treatment / all	0 / 0
Epistaxis
subjects affected / exposed	1 / 147 (0.68%)
occurrences causally related to treatment / all	0 / 1
deaths causally related to treatment / all	0 / 0
Cardiac disorders
Fibrillation ventricular
subjects affected / exposed	1 / 147 (0.68%)
occurrences causally related to treatment / all	0 / 1
deaths causally related to treatment / all	0 / 0
Cardiac failure
subjects affected / exposed	1 / 147 (0.68%)
occurrences causally related to treatment / all	0 / 1
deaths causally related to treatment / all	0 / 0
Surgical and medical procedures
Exeresis
subjects affected / exposed	1 / 147 (0.68%)
occurrences causally related to treatment / all	0 / 1
deaths causally related to treatment / all	0 / 0
Haematoma drainage
subjects affected / exposed	1 / 147 (0.68%)
occurrences causally related to treatment / all	0 / 1
deaths causally related to treatment / all	0 / 0
Abscess breast drainage
subjects affected / exposed	1 / 147 (0.68%)
occurrences causally related to treatment / all	0 / 1
deaths causally related to treatment / all	0 / 0
General disorders and administration site conditions
General physical health deterioration
subjects affected / exposed	2 / 147 (1.36%)
occurrences causally related to treatment / all	0 / 2
deaths causally related to treatment / all	0 / 1
Depressive symptom
subjects affected / exposed	1 / 147 (0.68%)
occurrences causally related to treatment / all	0 / 1
deaths causally related to treatment / all	0 / 0
Gastrointestinal disorders
Gastrointestinal obstruction
subjects affected / exposed	1 / 147 (0.68%)
occurrences causally related to treatment / all	0 / 1
deaths causally related to treatment / all	0 / 1
ACUTE CHOLECYSTITIS
subjects affected / exposed	1 / 147 (0.68%)
occurrences causally related to treatment / all	0 / 1
deaths causally related to treatment / all	0 / 0
GASTRO-DUODENAL ULCER
subjects affected / exposed	1 / 147 (0.68%)
occurrences causally related to treatment / all	0 / 1
deaths causally related to treatment / all	0 / 0
Respiratory, thoracic and mediastinal disorders
Distress respiratory
subjects affected / exposed	1 / 147 (0.68%)
occurrences causally related to treatment / all	0 / 1
deaths causally related to treatment / all	0 / 0
Musculoskeletal and connective tissue disorders
Radius fracture
subjects affected / exposed	1 / 147 (0.68%)
occurrences causally related to treatment / all	0 / 1
deaths causally related to treatment / all	0 / 0
Infections and infestations
Breast infection
subjects affected / exposed	1 / 147 (0.68%)
occurrences causally related to treatment / all	0 / 1
deaths causally related to treatment / all	0 / 0
Diverticulitis of colon
subjects affected / exposed	1 / 147 (0.68%)
occurrences causally related to treatment / all	0 / 1
deaths causally related to treatment / all	0 / 0

Frequency threshold for reporting non-serious adverse events: 5%

Non-serious adverse events	Overall trial
Total subjects affected by non serious adverse events
subjects affected / exposed	27 / 147 (18.37%)
Gastrointestinal disorders
Diarrhoea
subjects affected / exposed	11 / 147 (7.48%)
occurrences all number	11
Vomiting
subjects affected / exposed	7 / 147 (4.76%)
occurrences all number	7
Nausea
subjects affected / exposed	9 / 147 (6.12%)
occurrences all number	9

More information

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Were there any global substantial amendments to the protocol? No

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 reported

http://www.ncbi.nlm.nih.gov/pubmed/2270375

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Clinical trials

Clinical Trial Results:
Evaluation de l'efficacité et de la tolérance du Lanreotide LP 90 mg versus placebo dans la diminution de la lyphorrhée post curage axillaire dans les cancers du sein.

Trial information

Trial information

Subject disposition

Subject disposition

Baseline characteristics

Baseline characteristics

End points

End points

Primary: Postoperative lymphorrhea volume

Primary: Postoperative lymphorrhea volume

Secondary: Postoperative reduction of lymphorrhea volume

Secondary: Postoperative reduction of lymphorrhea volume

Secondary: Postoperative reduction of lymphorrhea volume

Secondary: Postoperative reduction of lymphorrhea volume

Secondary: Postoperative reduction of lymphorrhea volume

Secondary: Postoperative reduction of lymphorrhea volume

Adverse events

Adverse events

More information

Substantial protocol amendments (globally)

Interruptions (globally)

Limitations and caveats

Online references

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Clinical trials

Clinical Trial Results: Evaluation de l'efficacité et de la tolérance du Lanreotide LP 90 mg versus placebo dans la diminution de la lyphorrhée post curage axillaire dans les cancers du sein.

Trial information

Trial information

Subject disposition

Subject disposition

Baseline characteristics

Baseline characteristics

End points

End points

Primary: Postoperative lymphorrhea volume

Primary: Postoperative lymphorrhea volume

Secondary: Postoperative reduction of lymphorrhea volume

Secondary: Postoperative reduction of lymphorrhea volume

Secondary: Postoperative reduction of lymphorrhea volume

Secondary: Postoperative reduction of lymphorrhea volume

Secondary: Postoperative reduction of lymphorrhea volume

Secondary: Postoperative reduction of lymphorrhea volume

Adverse events

Adverse events

More information

Substantial protocol amendments (globally)

Interruptions (globally)

Limitations and caveats

Online references

More information

Clinical Trial Results:
Evaluation de l'efficacité et de la tolérance du Lanreotide LP 90 mg versus placebo dans la diminution de la lyphorrhée post curage axillaire dans les cancers du sein.