NCT02127073

Brief Summary

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
8

participants targeted

Target at below P25 for phase_2 breast-cancer

Timeline
Completed

Started Jan 2015

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 28, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 30, 2014

Completed
9 months until next milestone

Study Start

First participant enrolled

January 30, 2015

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 18, 2017

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 18, 2017

Completed
6.1 years until next milestone

Results Posted

Study results publicly available

November 9, 2023

Completed
Last Updated

November 9, 2023

Status Verified

November 1, 2023

Enrollment Period

2 years

First QC Date

April 28, 2014

Results QC Date

October 16, 2023

Last Update Submit

November 7, 2023

Conditions

Breast CancerDuctal Carcinoma in Situ

Keywords

Breast cancerDuctal carcinoma in situ (DCIS)Oxytocin

Outcome Measures

Primary Outcomes (1)

  • Percentage of Patients With Detection of microRNA in NAF, Serum, or Tissue

    3 years

Secondary Outcomes (1)

  • Percentage of Patients With Collection of ≥ 5 μL of Nipple Aspirate Fluid

    3 years

Study Arms (1)

Oxytocin

EXPERIMENTAL

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

Drug: Intranasal Oxytocin

Interventions

Intranasal OxytocinDRUG

Intranasal spray, one spray or 4 IU of oxytocin will be administered into each nostril of each patient about 15-30 minutes before NAF collection

Also known as: Syntocinon Spray
Oxytocin

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Columbia University Medical Center

New York, New York, 10032, United States

Location

MeSH Terms

Conditions

Breast NeoplasmsCarcinoma, Intraductal, Noninfiltrating

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue DiseasesAdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeBreast Carcinoma In SituCarcinoma in SituNeoplasms, Ductal, Lobular, and Medullary

Results Point of Contact

Title
Dr. Sheldon Feldman, Chief Breast Surgery and Breast Surgery Oncology
Organization
Montefiore Medical Center
sfeldman@montefiore.org
929-246-6300

Study Officials

  • Sheldon Feldman, MD

    Montefiore Medical Center

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 28, 2014

First Posted

April 30, 2014

Study Start

January 30, 2015

Primary Completion

January 18, 2017

Study Completion

September 18, 2017

Last Updated

November 9, 2023

Results First Posted

November 9, 2023

Record last verified: 2023-11

Locations

US(1)