Breast Cancer Clinical Trial
A Pre-Surgical PK Study of IM and Intraductally Delivered Fulvestrant
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.
Full 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.
Eligibility Criteria
Inclusion Criteria:
Female
18 years of age or older
Scheduled to undergo non-nipple sparing mastectomy for Invasive Breast Cancer or DCIS
Pathological diagnosis of Invasive Ductal Breast Cancer or Ductal Carcinoma in Situ requiring mastectomy or lumpectomy
Estrogen Receptor-positive pathology
ECOG performance scale of 0-1
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
Able to sign informed consent
Willing to use effective contraception for at least 100 days post study drug administration.
Exclusion Criteria:
Concurrent treatment with another anti-estrogen
Presence of an active infection requiring systemic therapy
The following conditions contra-indicating fulvestrant administration:
Subjects with bleeding diatheses, thrombocytopenia or current anticoagulant use (excluding aspirin and anti-inflammatories)
Subjects with a known hypersensitivity to fulvestrant or any of its formulation components including castor oil, alcohol, benzyl alcohol, and benzyl benzoate.
Severe hepatic impairment.
Prior surgery on the ipsilateral breast which interrupts communication of the ductal systems with the nipple
Prior radiation to the breast
Pregnant or lactating
Impaired cardiac function or history of cardiac problems of NYHA Class 111 and IV
Poor nutritional state as indicated by a BMI below 20.
Presence of serious infection not controlled with systemic therapy
History of allergies to Lidocaine or Novocain
Concurrent participation in an experimental drug study
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There are 2 Locations for this study
Baltimore Maryland, 21205, United States
New York New York, 10461, United States
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