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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT02540330
Recruitment Status : Recruiting
First Posted : September 3, 2015
Last Update Posted : April 12, 2018
Information provided by (Responsible Party):
Atossa Genetics, Inc.

August 28, 2015
September 3, 2015
April 12, 2018
March 2016
December 2018   (Final data collection date for primary outcome measure)
  • Safety and Tolerability of Two Delivery methods [ Time Frame: Up to 4 weeks ]
    Compare the number and severity of adverse events per CTCAE v4.0
  • Compare the pathological effects between the 2 routes of administration [ Time Frame: Up to 4 weeks ]
    Determine the pathological effects, specifically changes in Ki67, ER/PgR expression between the pre-fulvestrant biopsy and the post-fulvestrant surgical specimen.
number and severity of adverse events per CTCAE v4.0 [ Time Frame: 4 weeks ]
Complete list of historical versions of study NCT02540330 on Archive Site
Compare fulvestrant levels by route of administration [ Time Frame: Up to 4 weeks ]
Compare the tissue and circulating levels of fulvestrant following a single dose administered either intramuscularly or intraductallly
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A Pre-Surgical PK Study of IM and Intraductally Delivered Fulvestrant
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
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.
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Phase 2
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
  • Female Breast Carcinoma
  • Female Ductal Carcinoma In Situ
Drug: Fulvestrant
Other Name: Faslodex
  • Active Comparator: Intramuscular Fulvestrant
    500mg fulvestrant administered intramuscularly
    Intervention: Drug: Fulvestrant
  • Experimental: Intraductal Fulvestrant
    up to 500mg fulvestrant administered intraductally
    Intervention: Drug: Fulvestrant
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*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Same as current
December 2018
December 2018   (Final data collection date for primary outcome measure)

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
  9. 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:

    • 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
Sexes Eligible for Study: Female
18 Years and older   (Adult, Senior)
Contact: Stephen Quay, MD, PhD 206.419.4873
Contact: Janet R Rea, MSPH 206-799-7186
United States
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Plan to Share IPD: Undecided
Atossa Genetics, Inc.
Atossa Genetics, Inc.
Not Provided
Not Provided
Atossa Genetics, Inc.
April 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP