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:

Terminated

Phase:

Phase 2

Trial Eligibility

Document

Title

  • Brief Title: A Pre-Surgical PK Study of IM and Intraductally Delivered Fulvestrant
  • 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

Clinical Trial IDs

  • ORG STUDY ID: ATOS-2015-007
  • NCT ID: NCT02540330

Conditions

  • Female Breast Carcinoma
  • Female Ductal Carcinoma In Situ

Interventions

DrugSynonymsArms
FulvestrantFaslodexIntraductal Fulvestrant

Purpose

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.

Trial Arms

NameTypeDescriptionInterventions
Intramuscular FulvestrantActive Comparator500mg fulvestrant administered intramuscularly
  • Fulvestrant
Intraductal FulvestrantExperimentalup 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/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
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:Female
Healthy Volunteers:No

Primary Outcome Measures

Measure:Safety and Tolerability of Two Delivery methods
Time Frame:Up to 4 weeks
Safety Issue:
Description:Compare the number and severity of adverse events per CTCAE v4.0

Secondary Outcome Measures

Measure:Compare fulvestrant levels by route of administration
Time Frame:Up to 4 weeks
Safety Issue:
Description:Compare the tissue and circulating levels of fulvestrant following a single dose administered either intramuscularly or intraductallly

Details

Phase:Phase 2
Primary Purpose:Interventional
Overall Status:Terminated
Lead Sponsor:Atossa Genetics, Inc.

Last Updated

August 18, 2020