A Pre-Surgical PK Study of IM and Intraductally Delivered Fulvestrant (007)

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2016 by Atossa Genetics, Inc.
Sponsor:
Information provided by (Responsible Party):
Atossa Genetics, Inc.
ClinicalTrials.gov Identifier:
NCT02540330
First received: August 28, 2015
Last updated: October 18, 2016
Last verified: October 2016
  Purpose
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.

Condition Intervention Phase
Female Breast Carcinoma
Female Ductal Carcinoma In Situ
Drug: Fulvestrant
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: An Open Label, Phase 2 Pharmacokinetic Study of Pre-Surgical Intramuscular and Intraductal Fulvestrant in Women With Invasive Breast Cancer or DCIS Undergoing Mastectomy or Lumpectomy

Resource links provided by NLM:


Further study details as provided by Atossa Genetics, Inc.:

Primary Outcome Measures:
  • number and severity of adverse events per CTCAE v4.0 [ Time Frame: 4 weeks ]

Estimated Enrollment: 30
Study Start Date: March 2016
Estimated Study Completion Date: September 2017
Estimated Primary Completion Date: March 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Intramuscular Fulvestrant
500mg fulvestrant administered intramuscularly
Drug: Fulvestrant
Other Name: Faslodex
Experimental: Intraductal Fulvestrant
up to 500mg fulvestrant administered intraductally
Drug: Fulvestrant
Other Name: Faslodex

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Female
  2. 18 years of age or older
  3. Scheduled to undergo non-nipple sparing mastectomy for Invasive Breast Cancer or DCIS within 1 month
  4. Pathological diagnosis of Invasive Ductal Breast Cancer or Ductal Carcinoma in Situ requiring mastectomy
  5. Estrogen Receptor-positive pathology
  6. ECOG performance scale of 0-1
  7. Adequate organ function as defined by the following criteria:

    • Absolute neutrophil count (ANC) ≥ 1500/μl
    • Platelets ≥ 100,000/μl
    • Hemoglobin ≥ 9.0 g/dl
    • Creatinine ≤ 2 times upper limit of normal
    • Bilirubin ≤ 2 times upper limit of normal
    • Transaminases (AST/SGOT and ALT/SGPT) ≤ 2.5 times upper limit of normal
  8. Able to sign informed consent

Exclusion Criteria:

  1. Diagnosis of inflammatory breast carcinoma
  2. Concurrent treatment with another anti-estrogen
  3. Presence of an infection including ulcerations and fungal infections in the breast to be studied
  4. Any condition contraindicating fulvestrant administration:

    • Subjects with bleeding diatheses, thrombocytopenia or current anticoagulant use
    • Subjects with a known hypersensitivity to fulvestrant or any of its formulation components including castor oil, alcohol, benzyl alcohol, and benzyl benzoate.
    • Several hepatic impairments, define as Child-Pugh Class C or worse
  5. Prior breast surgery which interrupts communication of the ductal systems with the nipple
  6. Diagnosis of triple-negative or ER-negative breast cancer
  7. Non-Ductal Pathology: Lobular or Colloid type presence
  8. Subjects scheduled to undergo nipple sparing mastectomy
  9. Prior radiation to the breast or chest wall
  10. Pregnant or lactating
  11. Impaired renal function
  12. Impaired cardiac function or history of cardiac problems
  13. Poor nutritional state (as determined by clinician)
  14. Depressed bone marrow
  15. Presence of serious infection
  16. Presence of ascites (as determined by clinician)
  17. Presence of pleural effusion
  18. Allergies to Lidocaine or Novocain
  19. Allergies to imaging dyes
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02540330

Contacts
Contact: Stephen Quay, MD, PhD 206.419.4873 steven.quay@atossagenetics.com
Contact: Janet R Rea, MSPH 206-799-7186 janet.rea@atossagenetics.com

Locations
United States, New York
Columbia University Breast Center Recruiting
New York, New York, United States, 10032
Contact: Sheldon M Feldman, MD    212-305-1534      
Principal Investigator: Sheldon M Feldman, MD, FACS         
Sponsors and Collaborators
Atossa Genetics, Inc.
  More Information

Responsible Party: Atossa Genetics, Inc.
ClinicalTrials.gov Identifier: NCT02540330     History of Changes
Other Study ID Numbers: ATOS-2015-007 
Study First Received: August 28, 2015
Last Updated: October 18, 2016
Individual Participant Data  
Plan to Share IPD: Undecided

Additional relevant MeSH terms:
Carcinoma
Breast Neoplasms
Carcinoma in Situ
Carcinoma, Ductal
Carcinoma, Intraductal, Noninfiltrating
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases
Adenocarcinoma
Neoplasms, Ductal, Lobular, and Medullary
Fulvestrant
Estradiol
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Estrogen Receptor Antagonists
Estrogen Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Estrogens
Hormones

ClinicalTrials.gov processed this record on January 19, 2017