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

• Status: Terminated
• Trial end date: 2020-08-13
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Atossa Genetics, Inc.
• Treatments: Estradiol; Fulvestrant

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/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