A Pre-Surgical PK Study of IM and Intraductally Delivered Fulvestrant
| Status: | Recruiting |
|---|---|
| Conditions: | Breast Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 4/17/2018 |
| Start Date: | March 2016 |
| End Date: | December 2018 |
| Contact: | Stephen Quay, MD, PhD |
| Email: | steven.quay@atossagenetics.com |
| Phone: | 206.419.4873 |
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.
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.
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
We found this trial at
1
site
New York, New York 10467
Principal Investigator: Sheldon M Feldman, MD, FACS
Phone: 714-405-8578
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