MedTrace Logo

A Pre-Surgical PK Study of IM and Intraductally Delivered Fulvestrant

NCT02540330 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 3

Last updated 2024-04-03

Study results available
· View outcomes & findings →

Summary

This is an open-label, non-randomized pharmacokinetic study of fulvestrant in women scheduled for mastectomy or lumpectomy. Eligible subjects will be identified with breast cancer or DCIS. The first subject of each of five groups will receive fulvestrant intramuscularly. The subsequent 5 subjects of each group will receive fulvestrant by intraductal instillation. All subjects will be monitored for systemic and local adverse events during the procedure, and following the procedure until mastectomy or lumpectomy. Subjects that receive fulvestrant will undergo serial blood draws to determine fulvestrant blood concentration levels.

Conditions

  • Female Breast Carcinoma
  • Female Ductal Carcinoma In Situ

Interventions

DRUG

Fulvestrant

Sponsors & Collaborators

  • Atossa Therapeutics, Inc.

    lead INDUSTRY

Principal Investigators

  • Steven C Quay · Atossa Therapeutics, Inc.

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-03-31
Primary Completion
2020-08-13
Completion
2020-08-13
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02540330 on ClinicalTrials.gov