Pilot Study of Oxytocin and microRNA Identification in NAF, Serum, and Tissue in Women With Breast Cancer

What Was Tested

In this phase 2 trial, researchers set out to test Oxytocin.

The purpose of this study is to examine the genetic material called microRNA of three types of specimens from women with breast cancer.

It had 1 arm (groups): Oxytocin (experimental).

The registry classes the interventions as drug.

More on the Plan

Vast majority of breast cancers arise from ductal epithelium.

Ductal cells can be collected through the nipple orifice very early in breast cancer development.

The nipple aspirate fluid (NAF) can be used to identify biomarkers that predict risk of breast cancer.

To date, the biomarkers identified in nipple aspirate fluid (NAF) have limited utility due to the large volume of NAF required for data analysis.

Who Took Part

The registry lists 8 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: Clinical diagnosis of Ductal carcinoma in situ (DCIS) or invasive breast cancer. Candidate for breast conserving surgery or mastectomy.

The full record lists 2 inclusion and 3 exclusion criteria; among the exclusions: pregnant women; prior breast cancer diagnosis; adverse reaction to oxytocin in the past.

How the Study Was Run

It was run as a single-group and open-label study.

Nothing was hidden in this open-label Oxytocin study: the participants and staff both knew the treatment.

Everyone received the same intervention, so there was no separate comparison group inside the trial.

It started in 2015-01-30 with completion listed for 2017-01-18.

It ran at 1 site in United States.

Its stated primary purpose is basic science.

What Was Measured

The main thing measured (primary outcome): Percentage of Patients With Detection of microRNA in NAF, Serum, or Tissue (time frame: 3 years).

It also tracked 1 secondary outcome, for example Percentage of Patients With Collection of ≥ 5 μL of Nipple Aspirate Fluid.

What This Means in Plain Language

Put simply, this is a phase 2 trial of Oxytocin in 8 people.

Its size is small, so on its own it can only give an early look.

It ended early (terminated); results are posted on the registry, and this page does not restate them.

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