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

Montefiore Medicine Academic Health System

Status and phase: Terminated; Phase 2

Conditions: Breast Cancer; Ductal Carcinoma in Situ

Treatments: Drug: Intranasal Oxytocin

Study type: Interventional

Funder types: Other

Identifiers

NCT02127073

AAAL5203

Details and patient eligibility

About

The purpose of this study is to examine the genetic material called microRNA of three types of specimens from women with breast cancer. The study also seeks to examine the effectiveness of using a new agent called oxytocin to increase the amount of nipple fluid that can be collected during surgery.

Full description

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. Recent studies show intranasal oxytocin's utility in enhancing the yield of nipple aspirate fluid (NAF) among healthy, non-lactating female patients as well as those at high risk for breast cancer. This capability is crucial for the analysis of various markers associated with breast disease and cancer such as microRNAs. The primary aim of the study is to determine whether the microRNA profile characterization is feasible with the collection of tissue, serum and NAF in patients with in situ and invasive breast cancer. Intranasal oxytocin will be used to enhance fluid yielding of the NAF.

Enrollment: 8 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Clinical diagnosis of Ductal carcinoma in situ (DCIS) or invasive breast cancer
• Candidate for breast conserving surgery or mastectomy

Exclusion criteria

• Pregnant women
• Prior Breast Cancer diagnosis
• Adverse reaction to Oxytocin in the past

Trial design

Primary purpose: Basic Science

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

8 participants in 1 patient group

Oxytocin

Experimental group

Description:

Subjects would receive 4 IU of intranasal oxytocin; one spray in each nostril, single-use.

Treatment:

Drug: Intranasal Oxytocin