Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 2 of 7 for:    atossa

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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02540330
Recruitment Status : Terminated (Business decision)
First Posted : September 3, 2015
Results First Posted : April 5, 2022
Last Update Posted : April 5, 2022
Sponsor:
Information provided by (Responsible Party):
Atossa Genetics, Inc.

Brief Summary:
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 or disease Intervention/treatment Phase
Female Breast Carcinoma Female Ductal Carcinoma In Situ Drug: Fulvestrant Phase 2

Detailed Description:
This is an open-label, non-randomized pharmacokinetic study of pre-surgical fulvestrant in women scheduled for mastectomy or lumpectomy. Eligible subjects will be identified upon admission to the institution for surgical management of breast cancer or DCIS, specifically mastectomy or lumpectomy. There will be 5 groups, each consisting of 6 subjects. The first subject of each group will receive fulvestrant administered intramuscularly and the next 5 subjects will receive fulvestrant intraductally. Subjects where at least 1 suitable duct is identified may undergo nipple aspiration in order to facilitate duct identification and intraductal infusion of a fulvestrant accompanied by imaging (saline+ ultrasound). A maximum of 5 ducts will receive intraductal infusion of fulvestrant. Across all ducts, the total dose will not exceed 500 mg (10 mL). All subjects will be monitored for systemic and local adverse events during the procedure, immediately following the procedure, within 30 minutes, 1 hour, 4 hours and by phone following discharge on Days +1 and +2, +7, and pre-operative. Subsequent to mastectomy or lumpectomy, subjects will be assessed for systemic adverse events until discharge. Subjects that receive fulvestrant will undergo serial blood draws to determine fulvestrant blood concentration levels.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 3 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (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
Actual Study Start Date : March 2016
Actual Primary Completion Date : August 13, 2020
Actual Study Completion Date : August 13, 2020

Resource links provided by the National Library of Medicine

Drug Information available for: Fulvestrant

Arm Intervention/treatment
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




Primary Outcome Measures :
  1. Safety and Tolerability of Two Delivery Methods [ Time Frame: Up to 4 weeks ]
    Number of adverse events per CTCAE v4.0 after treatment with fulvestrant by route of administration



Information from the National Library of Medicine

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, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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
  4. Pathological diagnosis of Invasive Ductal Breast Cancer or Ductal Carcinoma in Situ requiring mastectomy or lumpectomy
  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 100 days post study drug administration.

Exclusion Criteria:

  1. Concurrent treatment with another anti-estrogen
  2. Presence of an active infection requiring systemic therapy
  3. The following conditions contra-indicating fulvestrant administration:

    1. Subjects with bleeding diatheses, thrombocytopenia or current anticoagulant use (excluding aspirin and anti-inflammatories)
    2. Subjects with a known hypersensitivity to fulvestrant or any of its formulation components including castor oil, alcohol, benzyl alcohol, and benzyl benzoate.
    3. Severe hepatic impairment.
  4. Prior surgery on the ipsilateral breast which interrupts communication of the ductal systems with the nipple
  5. Prior radiation to the breast
  6. Pregnant or lactating
  7. Impaired cardiac function or history of cardiac problems of NYHA Class 111 and IV
  8. Poor nutritional state as indicated by a BMI below 20.
  9. Presence of serious infection not controlled with systemic therapy
  10. History of allergies to Lidocaine or Novocain
  11. Concurrent participation in an experimental drug study

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02540330


Locations
Layout table for location information
United States, Maryland
The Johns Hopkins School of Medicine
Baltimore, Maryland, United States, 21205
United States, New York
Montefiore Medical Center
New York, New York, United States, 10461
Sponsors and Collaborators
Atossa Genetics, Inc.
Investigators
Layout table for investigator information
Study Chair: Steven C Quay Atossa Therapeutics, Inc.
  Study Documents (Full-Text)

Documents provided by Atossa Genetics, Inc.:
Layout table for additonal information
Responsible Party: Atossa Genetics, Inc.
ClinicalTrials.gov Identifier: NCT02540330    
Other Study ID Numbers: ATOS-2015-007
First Posted: September 3, 2015    Key Record Dates
Results First Posted: April 5, 2022
Last Update Posted: April 5, 2022
Last Verified: March 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for 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
Breast Carcinoma In Situ
Fulvestrant
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Estrogen Receptor Antagonists
Estrogen Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs