A Trial of the ForeCYTE Breast Aspirator for Cytological Testing of Nipple Aspirate Fluid in Women 30-55 Years Old

A Single-arm, Multi-center Trial of the ForeCYTE Breast Aspirator for Sample Collection and Cytological Testing of Nipple Aspirate Fluid in Women 30-55 Years of Age

The purpose of this study is to measure the performance of the ForeCYTE Breast Aspirator for the collection and processing of Nipple Aspirate Fluid (NAF) specimens for cytology. Including collecting, processing and shipping samples, training staff, processing samples, sample interpretation and accurate and timely reporting in a manner resembling routine clinical use. The study will include a subset of patients who are known carriers of a BRCA germline mutation. NAF from this subset will be submitted for molecular testing in addition to cytology.

Study Overview

• Status: Withdrawn
• Conditions: Breast Cancer, Preneoplastic Conditions, BRCA
• Intervention / Treatment: Device: ForeCYTE Breast Aspirator

• Study Type: Interventional
• Phase: Phase 3

Contacts and Locations

Study Locations

• Israel
  • Lower Galilee
    • Poriya, Lower Galilee, Israel, 15208
      • The Baruch Padeh Medical Center
  • Upper Galilee
    • Zefat, Upper Galilee, Israel, 13100
      • Ziv Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years to 55 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

1. Healthy, female, age 30-55 years, from whom bi-lateral specimens can be obtained.

   The following additional considerations apply:

   • Women with prior mastectomy/lumpectomy may be considered for NAF-collection in the contralateral (non-operated) breast only if they were:

     • Stage I or Stage II at the time of surgery;
     • Have completed any and all hormonal therapy, chemotherapy, or targeted therapy at least one year prior to inclusion;
     • Are considered disease-free (NED- No Evidence of Disease) at the time of study entry;
   • Women under the age 30 may be enrolled if they are within 10 years of the age at diagnosis of breast cancer in a first-degree relative. No subject under the age of 21 may be enrolled.
2. Any woman for whom NAF-cytology testing is considered to be beneficial by her physician. This includes, but is not limited to women with first- and/or second degree relatives with breast- or ovarian cancer. Known presence of a BRCA-1 or BRCA-2 germline mutation is allowed but not required. If known, any such mutation will be noted on the Case Report Form. The protocol does not provide for testing of women without known germ-line mutations.
3. Non-lactating and non-pregnant.
4. Good general health as determined by medical history, breast disease/cancer history, and clinical breast exam.
5. Willing to give informed consent and follow study procedures as directed.

Exclusion Criteria

1. Medical condition/psychiatric conditions making subjects a poor candidate for study, as determined by the Principal Investigator.
2. Pregnancy or suspicion of pregnancy.
3. Open cutaneous wounds or atopic dermatitis in the area of the nipple-areolar complex.
4. No or inverted nipple on the breast unfit for fluid collection, or significant prior surgery in the area of the nipple-areolar complex.
5. Participation in an investigational drug or device study less than 30 days prior to enrollment in this study.
6. Pregnancy, childbirth, or lactation less than 90 days prior to enrollment in this study.
7. Acute illness, including taking antibiotics, analgesics, antipyretics and/or cold medications less than 7 days prior to enrollment in this study.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Screening
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: ForeCYTE Breast Aspirator - Nipple Aspirate Fluid Collection; Nipple Aspirate is collected using the ForeCYTE Breast Aspirator	Device: ForeCYTE Breast Aspirator

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
NAF cytological classification(s), according to the modified King Classification.	1 day (single time point)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The IBIS (Tyrer-Cuzick) risk score (10-year and lifetime breast cancer risk estimate.		1 day (single time point)
Safety, as reported by adverse events experienced after NAF collection with ForeCYTE Breast Aspirator		1 day (single time point)
micro-RNA (subgroup analysis of BRCA mutation carriers only)	development of micro-RNA panel that signals the transition to breast cancer	1 day (single time point)

Collaborators and Investigators

• Sponsor: Atossa Therapeutics, Inc.
• Investigators: Study Director: Jelle Kylstra, Atossa Therapeutics, Inc.

Study record dates

Study Major Dates

• Study Start: September 1, 2015
• Primary Completion (Anticipated): December 1, 2015
• Study Completion (Anticipated): March 1, 2016

Study Registration Dates

• First Submitted: September 1, 2015
• First Submitted That Met QC Criteria: September 2, 2015
• First Posted (Estimate): September 3, 2015

Study Record Updates

• Last Update Posted (Estimate): January 25, 2016
• Last Update Submitted That Met QC Criteria: January 21, 2016
• Last Verified: January 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Precancerous Conditions
• Other Study ID Numbers: GCP005