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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

August 28, 2015
October 18, 2016
March 2016
March 2017   (Final data collection date for primary outcome measure)
number and severity of adverse events per CTCAE v4.0 [ Time Frame: 4 weeks ]
Same as current
Complete list of historical versions of study NCT02540330 on ClinicalTrials.gov Archive Site
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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.
Not Provided
Interventional
Phase 2
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: 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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
30
September 2017
March 2017   (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

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)
No
Contact: Stephen Quay, MD, PhD 206.419.4873 steven.quay@atossagenetics.com
Contact: Janet R Rea, MSPH 206-799-7186 janet.rea@atossagenetics.com
United States
 
 
NCT02540330
ATOS-2015-007
No
Not Provided
Undecided
Not Provided
Atossa Genetics, Inc.
Atossa Genetics, Inc.
Not Provided
Not Provided
Atossa Genetics, Inc.
October 2016

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