Evaluation of the Effects of Pasireotide LAR Administration on Lymphocele Prevention after Axillary Node Dissection for Breast Cancer: Results of a Randomized Non-Comparative Phase 2 Study.

Chéreau E, Uzan C, Boutmy-Deslandes E, Zohar S, Bézu C, Mazouni C, Garbay JR, Daraï E, Rouzier R

PloS one9 Jun 2016Cited by 6 (Europe PMC)

PMID27280398PMCIDPMC4900597DOI10.1371/journal.pone.0156096PepBankPUB-27280398

Summary

ObjectiveThe aim of this study was to assess the efficacy (response rate centered on 80%) of a somatostatin analog with high affinity for 4 somatostatin receptors in reducing the postoperative incidence of symptomatic lymphocele formation following total mastectomy with axillary lymph node dissection.SettingThis prospective, double-blind, randomised, placebo-controlled, phase 2 trial was conducted in two secondary care centres.ParticipantsAll female patients for whom mastectomy and axillary lymph node dissection were indicated were eligible for the study, including patients who had received neo-adjuvant chemotherapy. Main exclusion criteria were related to diabetes, cardiac insufficiency, disorder of cardiac conduction or hepatic failure.InterventionsPatients were randomised to receive one injection of either prolonged-release pasireotide 60 mg or placebo (physiological serum), which were administered intramuscularly 7 to 10 days before the scheduled surgery. The study was conducted in a double-blind manner.Primary and secondary outcome measuresThe primary outcome measure was the percentage of patients who did not develop post-operative axillary symptomatic lymphoceles during the 2 postoperative months. Secondary endpoints were the total quantity of lymph drained, duration and daily volume of drainage and aspirated volumes of lymph.ResultsNinety-one patients were randomised. Ninety patients were evaluable: 42 patients received pasireotide, and 48 patients received placebo. The mean estimated response rate were 62.4% (95% Credibility Interval [CrI]: 48.6%-75.3%) in the treatment group and 50.2% (95% CrI: 37.6%-62.8%) in the placebo group. Overall safety was comparable across groups, and one serious adverse event occurred. In the treatment group, one patient with known insulin-depe*ndent diabetes required hospitalization for hyperglycaemia.ConclusionsWith this phase 2 preliminary study, even if our results indicate a trend towards a reduction in symptomatic lymphocele, pre-operative injection of pasireotide failed to achieve a response rate centered on 80%. Pharmacokinetics analysis suggests that effect of pasireotide could be optimised.Trial registrationClinicalTrials.gov NCT01356862.

CC BYText from Europe PMC. Highlighted sentences are the source of results.

Results from this study3

3 results from studies that gave the peptide. 3 results from people.

01HumanRandomized controlled trialEfficacy outcome
After mastectomy and axillary dissection, estimated lymphocele-free response was 62.4% with pasireotide versus 50.2% with placebo, which the authors describe as a trend that did not reach the 80% target response rate.
In plain wordsAfter mastectomy, the estimated share without symptomatic lymphoceles was 62.4% with pasireotide and 50.2% with placebo, a trend short of the 80% target.
Peptide
Pasireotide
Outcome
IncreaseAbsence of symptomatic lymphocele
Study
n = 90
Comparator
Placebo
Analysis
Primary
Outcome group
Postoperative Complications · Whole body
Studied dose
60 mg, one injection · intramuscular · single injection 7 to 10 days before surgeryAs given in this study (human).
Measurements
Estimated response
62.4%
pasireotide
95% CrI
48.6 to 75.3%
pasireotide
Estimated response
50.2%
placebo
95% CrI
37.6 to 62.8%
placebo
Source sentences
Summary
The mean estimated response rate were 62.4% (95% Credibility Interval [CrI]: 48.6%-75.3%) in the treatment group and 50.2% (95% CrI: 37.6%-62.8%) in the placebo group.
5 context sentences(design, population, supporting numbers)
Summary · context
With this phase 2 preliminary study, even if our results indicate a trend towards a reduction in symptomatic lymphocele, pre-operative injection of pasireotide failed to achieve a response rate centered on 80%.
Summary · context
The primary outcome measure was the percentage of patients who did not develop post-operative axillary symptomatic lymphoceles during the 2 postoperative months.
Summary · context
All female patients for whom mastectomy and axillary lymph node dissection were indicated were eligible for the study, including patients who had received neo-adjuvant chemotherapy.
Summary · context
Patients were randomised to receive one injection of either prolonged-release pasireotide 60 mg or placebo (physiological serum), which were administered intramuscularly 7 to 10 days before the scheduled surgery.
Summary · context
Ninety patients were evaluable: 42 patients received pasireotide, and 48 patients received placebo.
Show in the study text Report a problemFND-2728039801
02HumanRandomized controlled trialSafety outcome
In mastectomy and axillary dissection patients, overall safety was comparable between pasireotide and placebo.
In plain wordsIn mastectomy and axillary dissection patients, overall safety was comparable between pasireotide and placebo.
Peptide
Pasireotide
Outcome
No significant changeOverall safety
Study
n = 90
Comparator
Placebo
Outcome group
Adverse events · Whole body
Studied dose
60 mg, one injection · intramuscular · single injection 7 to 10 days before surgeryAs given in this study (human).
Source sentences
Summary
Overall safety was comparable across groups, and one serious adverse event occurred.
3 context sentences(design, population, supporting numbers)
Summary · context
All female patients for whom mastectomy and axillary lymph node dissection were indicated were eligible for the study, including patients who had received neo-adjuvant chemotherapy.
Summary · context
Patients were randomised to receive one injection of either prolonged-release pasireotide 60 mg or placebo (physiological serum), which were administered intramuscularly 7 to 10 days before the scheduled surgery.
Summary · context
Ninety patients were evaluable: 42 patients received pasireotide, and 48 patients received placebo.
Show in the study text Report a problemFND-2728039802
03HumanNon-randomized trialSafety outcome
In the pasireotide group after mastectomy and axillary dissection, one patient with insulin-dependent diabetes required hospitalization for hyperglycaemia.
In plain wordsIn the pasireotide group after mastectomy and axillary dissection, one patient with insulin-dependent diabetes needed hospital treatment for high blood glucose.
Peptide
Pasireotide
Outcome
Not applicableHospitalization for hyperglycaemia
Study
n = 42
Outcome group
Adverse events · Whole body
Studied dose
60 mg, one injection · intramuscular · single injection 7 to 10 days before surgeryAs given in this study (human).
Source sentences
Summary
In the treatment group, one patient with known insulin-depe*ndent diabetes required hospitalization for hyperglycaemia.
3 context sentences(design, population, supporting numbers)
Summary · context
All female patients for whom mastectomy and axillary lymph node dissection were indicated were eligible for the study, including patients who had received neo-adjuvant chemotherapy.
Summary · context
Patients were randomised to receive one injection of either prolonged-release pasireotide 60 mg or placebo (physiological serum), which were administered intramuscularly 7 to 10 days before the scheduled surgery.
Summary · context
Ninety patients were evaluable: 42 patients received pasireotide, and 48 patients received placebo.
Show in the study text Report a problemFND-2728039803

AI wrote and checked these results. AI can make mistakes, so check important results against the source.

Registered trials1

Trials this study reports on, or that list this study as a reference. Registry data from ClinicalTrials.gov.

1 trial · 1 completed · source ClinicalTrials.gov (opens in a new tab)

CompletedPhase 2NCT01356862

Pasireotide LAR Administration in Lymphocele Prevention After Axillary Node Dissection for Breast Cancer

Alliance Pour La Recherche en Cancerologien = 91Sept 2010 to Jan 2013

Breast Cancer

Trial page ClinicalTrials.govUpdated 25 Jan 2017

Version history

PepBank keeps every version of the data on this study. Status changes from Retraction Watch, Europe PMC and Crossref are listed with their source.

Version 2Current
28 Oct 2026, 02:03 UTC
Study results updated
Version 1
27 Oct 2026, 16:34 UTC
First added · source update from Europe PMC

Subjects

Terms as the source lists them.

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