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

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.

Conditions

  • Female Breast Carcinoma
  • Female Ductal Carcinoma In Situ

Eligibility

Eligible Ages
Over 18 Years
Eligible Genders
Female
Accepts Healthy Volunteers
No

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:
  8. Absolute neutrophil count (ANC) ≥ 1500/μl
  9. Platelets ≥ 100,000/μl
  10. Hemoglobin ≥ 9.0 g/dl
  11. Creatinine ≤ 2 times upper limit of normal
  12. Bilirubin ≤ 2 times upper limit of normal
  13. Transaminases (AST/SGOT and ALT/SGPT) ≤ 2.5 times upper limit of normal
  14. Able to sign informed consent
  15. Willing to use effective contraception for at least 28-days post study drug administration.

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:
  5. Subjects with bleeding diatheses, thrombocytopenia or current anticoagulant use
  6. Subjects with a known hypersensitivity to fulvestrant or any of its formulation components including castor oil, alcohol, benzyl alcohol, and benzyl benzoate.
  7. Several hepatic impairments, define as Child-Pugh Class C or worse
  8. Prior breast surgery which interrupts communication of the ductal systems with the nipple
  9. Diagnosis of triple-negative or ER-negative breast cancer
  10. Non-Ductal Pathology: Lobular or Colloid type presence
  11. Subjects scheduled to undergo nipple sparing mastectomy
  12. Prior radiation to the breast or chest wall
  13. Pregnant or lactating
  14. Impaired renal function
  15. Impaired cardiac function or history of cardiac problems
  16. Poor nutritional state (as determined by clinician)
  17. Depressed bone marrow
  18. Presence of serious infection
  19. Presence of ascites (as determined by clinician)
  20. Presence of pleural effusion
  21. Allergies to Lidocaine or Novocain
  22. Allergies to imaging dyes

Study Design

Phase
Phase 2
Study Type
Interventional
Allocation
Non-Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Active Comparator
Intramuscular Fulvestrant
500mg fulvestrant administered intramuscularly
  • Drug: Fulvestrant
    Other names:
    • Faslodex
Experimental
Intraductal Fulvestrant
up to 500mg fulvestrant administered intraductally
  • Drug: Fulvestrant
    Other names:
    • Faslodex

Recruiting Locations

Montefiore Medical Center
New York, New York 10461
Contact:
ameriangel M Roman
714-405-8578
aromaner@montefiore.org

More Details

Status
Recruiting
Sponsor
Atossa Genetics, Inc.

Study Contact

Steven C Quay, MD, PhD
206.419.4873
steven.quay@atossagenetics.com