Clinical Trials /

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

NCT02540330

Description:

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.

Related Conditions:
  • Breast Carcinoma
Recruiting Status:

Recruiting

Phase:

Phase 2

Trial Eligibility

Document

PK Study of Pre-Surgical Intramuscular and Intraductal <span class="go-doc-concept go-doc-intervention">Fulvestrant</span> in Women With Invasive <span class="go-doc-concept go-doc-disease">Breast Cancer</span> or DCIS Undergoing Mastectomy

Title

  • Brief Title: PK Study of Pre-Surgical Intramuscular and Intraductal Fulvestrant in Women With Invasive Breast Cancer or DCIS Undergoing Mastectomy
  • 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
  • Clinical Trial IDs

    NCT ID: NCT02540330

    ORG ID: ATOS-2015-007

    Trial Conditions

    Female Breast Carcinoma

    Female Ductal Carcinoma In Situ

    Trial Interventions

    Drug Synonyms Arms
    Fulvestrant Faslodex Intramuscular Fulvestrant, Intraductal Fulvestrant

    Trial Purpose

    This is an open-label, non-randomized pharmacokinetic study of pre-surgical fulvestrant in
    women scheduled for mastectomy. Eligible subjects will be identified with breast cancer or
    DCIS, specifically mastectomy. The first 6 subjects will be treated with intramuscular
    fulvestrant. The subsequent 24 subjects 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. Subjects that receive
    fulvestrant will undergo serial blood draws to determine fulvestrant blood concentration
    levels.

    Detailed Description

    Trial Arms

    Name Type Description Interventions
    Intramuscular Fulvestrant Active Comparator 500mg fulvestrant administered intramuscularly Fulvestrant
    Intraductal Fulvestrant Experimental up to 500mg fulvestrant administered intraductally Fulvestrant

    Eligibility 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
    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/l

    - Platelets 100,000/l

    - 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

    Minimum Eligible Age: 18 Years

    Maximum Eligible Age: N/A

    Eligible Gender: Female

    Primary Outcome Measures

    number and severity of adverse events per CTCAE v4.0

    Secondary Outcome Measures

    Trial Keywords