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

NCT01356862 | Completed Phase 2 DMC

• 1 other identifier: APREC-S-2010-01
• Study Type: interventional
• Target: 91
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Breast Cancer

Keywords

mastectomy; axillary node dissection; adjuvant or neoadjuvant

Outcome Measures

Primary Outcomes (1)

• aspirations global volume of lymphoceles

  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 (≤).

  1 to 32 days after surgery

Study Arms (2)

PASIREOTIDE

EXPERIMENTAL

INTRAMUSCULAR INJECTION OF PASIREOTIDE 60 MG

Drug: PASIREOTIDE

PLACEBO

PLACEBO COMPARATOR

INTRAMUSCULAR INJECTION OF PLACEBO

Drug: PLACEBO

Interventions

PASIREOTIDE DRUG

One INTRAMUSCULAR INECTION OF PASIREOTIDE 60 MG 10 TO 7 DAYS BEFORE SURGERY

PASIREOTIDE

PLACEBO DRUG

ONE INJECTION OF PLACEBO 10 TO 7 DAYS BEFORE SURGERY

PLACEBO

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Alliance Pour La Recherche en Cancerologie: lead

Study Sites (2)

Tenon Hospital

Paris, France, 75020, France

Location

Institut Gustave ROUSSY

Villejuif, France, 94805, France

Location

Related Publications (1)

• Chereau E, Uzan C, Boutmy-Deslandes E, Zohar S, Bezu C, Mazouni C, Garbay JR, Darai E, Rouzier R. 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. PLoS One. 2016 Jun 9;11(6):e0156096. doi: 10.1371/journal.pone.0156096. eCollection 2016.

  PMID: 27280398 DERIVED

MeSH Terms

Conditions

Breast Neoplasms

Interventions

pasireotide

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 18, 2011
• First Posted: May 20, 2011
• Study Start: September 1, 2010
• Primary Completion: October 1, 2012
• Study Completion: January 1, 2013
• Last Updated: January 25, 2017

Record last verified: 2017-01

Locations

FR (2)