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

NCT02540330 | Terminated Phase 2 Results FDA Drug

• 1 other identifier: ATOS-2015-007
• Study Type: interventional
• Target: 3
• Locations: 1 country
• Sites: 3

Brief 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.

Conditions

Female Breast Carcinoma; Female Ductal Carcinoma In Situ

Outcome Measures

Primary Outcomes (1)

• Safety and Tolerability of Two Delivery Methods

  Number of adverse events per CTCAE v4.0 after treatment with fulvestrant by route of administration

  Up to 4 weeks

Study Arms (2)

Intramuscular Fulvestrant

ACTIVE COMPARATOR

500mg fulvestrant administered intramuscularly

Drug: Fulvestrant

Intraductal Fulvestrant

EXPERIMENTAL

up to 500mg fulvestrant administered intraductally

Drug: Fulvestrant

Interventions

Fulvestrant DRUG

Also known as: Faslodex

Intraductal Fulvestrant; Intramuscular Fulvestrant

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Female
• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Atossa Therapeutics, Inc.: lead

Study Sites (3)

The Johns Hopkins School of Medicine

Baltimore, Maryland, 21205, United States

Location

Columbia University Medical Center

New York, New York, 10032, United States

Location

Montefiore Medical Center

The Bronx, New York, 10461, United States

Location

MeSH Terms

Interventions

Fulvestrant

Intervention Hierarchy (Ancestors)

Estradiol; Estrenes; Estranes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Estradiol Congeners; Gonadal Steroid Hormones; Gonadal Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists

Results Point of Contact

• Title: Heather Fraser, VP Clinical, Regulatory & CMC
• Organization: Atossa Therapeutics, Inc.

heather.fraser@atossainc.com

206-707-3088

Study Officials

• Steven C Quay

  Atossa Therapeutics, Inc.

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 28, 2015
• First Posted: September 3, 2015
• Study Start: March 1, 2016
• Primary Completion: August 13, 2020
• Study Completion: August 13, 2020
• Last Updated: April 3, 2024
• Results First Posted: April 5, 2022

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)