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

What Was Tested

This registered phase 2 trial tested Pasireotide.

The principal morbidity following axillary node dissection within the scope of breast cancer surgery is the post-operative development of lymphocele.

It had two arms (groups): PASIREOTIDE (experimental) and PLACEBO (placebo comparator).

INTRAMUSCULAR INJECTION OF PLACEBO.

The registry classes the interventions as drug.

More on the Plan

The principal morbidity following axillary node dissection within the scope of breast cancer surgery is the postoperative development of lymphocele following the removal of an axillary drain.

This may be a source of pain, repeated aspiration, infection and delayed local healing.

Pasireotide, a somatostatin analog under evaluation and possessing a high affinity for somatostatine receptors (30 to 40 times greater for sst1 and sst5 receptors, 5 times greater for sst3 and equivalent for sst2) is an attractive molecule in this indication.

It can inhibit gastrointestinal endocrine and exocrine secretion and has an anti-inflammatory action (1).

Who Took Part

The registry lists 91 actual participants took part.

It was open to women only aged from 18 years with no upper age limit.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: 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.

The full record lists 4 inclusion and 24 exclusion criteria; among the exclusions: patient under the age of 18 years; patient who does not understand french; patient not covered by the french national health insurance system.

How the Study Was Run

It was run as a randomized, parallel-group and triple-blind study.

The participants were allocated by chance, so the Pasireotide group and the comparison group should start out alike.

The Pasireotide group and the comparison group ran side by side rather than switching.

Neither the participants nor the staff measuring them knew who was on Pasireotide, so expectations could not easily colour the readings.

Those kept unaware of assignments: participant, care provider and investigator.

It started in 2010-09 with completion listed for 2012-10.

It ran at 2 sites in France (2).

Its stated primary purpose is prevention.

What Was Measured

Primary outcome: aspirations global volume of lymphoceles (time frame: 1 to 32 days after surgery).

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of Pasireotide in 91 people.

The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Pasireotide compound page, all human trials.