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.



Eligible Ages
Over 18 Years
Eligible Genders
Accepts Healthy Volunteers

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 2
Study Type
Intervention Model
Parallel Assignment
Primary Purpose
None (Open Label)

Arm Groups

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

Recruiting Locations

Montefiore Medical Center
New York, New York 10461
ameriangel M Roman

More Details

Atossa Genetics, Inc.

Study Contact

Steven C Quay, MD, PhD


Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.