Pasireotide LAR Administration in Lymphocele Prevention After Axillary Node Dissection for Breast Cancer (SOM 230)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2011 by Alliance Pour La Recherche en Cancerologie.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Alliance Pour La Recherche en Cancerologie
ClinicalTrials.gov Identifier:
NCT01356862
First received: May 18, 2011
Last updated: May 19, 2011
Last verified: May 2011
  Purpose

The principal morbidity following axillary node dissection within the scope of breast cancer surgery is the post-operative development of lymphocele. According to the literature, incidence can vary from 4 to 89% depending on the type of surgery, whether or not a drain is inserted or a compression dressing applied and the time at which the drain is removed… In our experience, the incidence is 40% [IGR (Gustave Roussy Institute) data focusing on 70 patients between November 2008 and February 2009]

Encouraging results in terms of reducing postoperative lymphoceles as well as drainage duration and volume using Octreotide have been recorded in two recent studies. A new molecule developed by Novartis Laboratories, namely pasireotide, is a somatostatin analog possessing strong affinity for several somatostatin receptors (30 to 40 times greater for sst1 and sst5, 5 times greater for sst3 and equivalent for sst2)

The purpose of this trial is to assess the efficacy of a pre-surgical injection of pasireotide LAR in reducing the postoperative incidence of symptomatic lymphoceles following axillary node dissection.

The secondary objectives are to assess the efficacy of prolonged release pasireotide on the duration of postoperative drainage, the daily drainage volume, the total drainage volume, the number of repeated lymphocele aspirations and the volume, the total volume of lymph aspirated, the incidence of postoperative febrile episodes, the length of hospital stay, and the length of time to onset of adjuvant chemotherapy. It is also to assess the safety of prolonged release pasireotide.

The primary objective of this study is to assess the efficacy of a preoperative prolonged release pasireotide injection in the reduction in the incidence of symptomatic, postoperative axillary lymphoceles following mastectomy-axillary node dissection.


Condition Intervention Phase
Breast Cancer
Drug: PASIREOTIDE
Drug: PLACEBO
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Prevention
Official Title: Evaluation of the Effect of Pasireotide LAR Administration in the Lymphocele Prevention After Axillary Node Dissection for Breast Cancer

Resource links provided by NLM:


Further study details as provided by Alliance Pour La Recherche en Cancerologie:

Primary Outcome Measures:
  • aspirations global volume of lymphoceles [ Time Frame: 1 to 32 days after surgery ] [ Designated as safety issue: Yes ]
    the patients ratio who did not have post-operative axillary symptomatic lymphoceles defined as the absence of aspiration or a unique or iterative aspirations global volume of lymphoceles inferior to 60cc inclusive (≤) in the 28 days after the intervention or a systematic aspiration volume at the 28th day inferior to 120cc inclusive (≤).


Estimated Enrollment: 90
Study Start Date: September 2010
Estimated Study Completion Date: July 2012
Estimated Primary Completion Date: April 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: PASIREOTIDE
INTRAMUSCULAR INJECTION OF PASIREOTIDE 60 MG
Drug: PASIREOTIDE
One INTRAMUSCULAR INECTION OF PASIREOTIDE 60 MG 10 TO 7 DAYS BEFORE SURGERY
Other Name: PASIREOTIDE
Placebo Comparator: PLACEBO
INTRAMUSCULAR INJECTION OF PLACEBO
Drug: PLACEBO
ONE INJECTION OF PLACEBO 10 TO 7 DAYS BEFORE SURGERY
Other Name: PLACEBO

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Female patient aged 18 years or over.
  • Patient understands French.
  • Patient covered by the French national health insurance system.
  • Any female patient scheduled for breast surgery with mastectomy and axillary node dissection indicated at the pre-surgical stage.

Exclusion Criteria:

  • Patient under the age of 18 years.
  • Patient who does not understand French.
  • Patient not covered by the French national health insurance system.
  • Patient exhibiting one or more contraindications to anesthesia and surgery.
  • Patient with a contra-indication to pasireotide
  • Refusal by the patient
  • Scheduled sentinel node procedure
  • Abnormal coagulation or curative anticoagulant treatment
  • Women of child-bearing potential without effective contraception,
  • Pregnant or breast-feeding women
  • Poorly controlled diabetes (HbA1c > 8%)
  • History of radiotherapy
  • Recurrent breast cancer
  • Patient with a congestive cardiac insufficiency (NYHA category III or IV), an instable angina pectoris, sustained ventricular tachycardia or ventricular fibrillation episodes or history of myocardial infarction during the last 6 months.
  • Patient presenting an extension of QT interval (QT corrected according to the Fridericia formula (QTcF)) at the screening or baseline (predose) > 450msec
  • History of syncope or family history of sudden death or significant cardiac arrhythmia
  • Risk factors for torsades de pointes: hypokaliaemia, hypomagnesaemia, known structural or ischaemic cardiac disease, bradycardia (HR<55/min) or high grade AV block
  • Concomitant disease that could prolong QT or increase exposure to the study medication including dehydration, renal or hepatic impairment
  • Concomitant medication known to increase the QT interval
  • Patient with an hepatic pathology such as cirrhosis, chronic hepatitis active or persistent, or an elevation of ALAT rate, ASAT rate twice higher than the normal superior limit (NSL)
  • Patient having leucocytes < 3x109/L, Hb < 90% LIN, platelets < 100x109/L
  • Patient having a pathology or medical history susceptible to interfere with the realization of the study or results evaluation according to the judgment of the investigator or the study monitor
  • Patient participating to another clinical trial with another molecule in study during the month before the first dose
  • Known oversensitivity to somatostatine analogs or another component of prolonged release pasireotide or prolonged release octreotide formulations.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01356862

Contacts
Contact: stephane PROVENT 0033156017578 stephane.provent@tnn.aphp.fr
Contact: roman rouzier, PHD 0033156017571 roman.rouzier@tnn.aphp.fr

Locations
France
Tenon Hospital Recruiting
Paris, France, 75020
Principal Investigator: roman rouzier, PHD         
Institut Gustave ROUSSY Recruiting
Villejuif, France, 94805
Contact: Catherine UZAN, PHD    0033142116668    Catherine.UZAN@igr.fr   
Sub-Investigator: Chafika MAZOUNI, PHD         
Sponsors and Collaborators
Alliance Pour La Recherche en Cancerologie
  More Information

No publications provided

Responsible Party: Pr ROMAN ROUZIER, APREC
ClinicalTrials.gov Identifier: NCT01356862     History of Changes
Other Study ID Numbers: APREC-S-2010-01
Study First Received: May 18, 2011
Last Updated: May 19, 2011
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
France: Committee for the Protection of Personnes

Keywords provided by Alliance Pour La Recherche en Cancerologie:
mastectomy
axillary node dissection
adjuvant or neoadjuvant

Additional relevant MeSH terms:
Breast Neoplasms
Lymphocele
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Cysts
Lymphatic Diseases

ClinicalTrials.gov processed this record on July 24, 2014