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A Pre-Surgical PK Study of IM and Intraductally Delivered Fulvestrant (007)

Primary Purpose

Female Breast Carcinoma, Female Ductal Carcinoma In Situ

Status

Terminated

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

Fulvestrant

About this trial

This is an interventional treatment trial for Female Breast Carcinoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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:
1. Subjects with bleeding diatheses, thrombocytopenia or current anticoagulant use (excluding aspirin and anti-inflammatories)
2. Subjects with a known hypersensitivity to fulvestrant or any of its formulation components including castor oil, alcohol, benzyl alcohol, and benzyl benzoate.
3. 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

Sites / Locations

The Johns Hopkins School of Medicine
Montefiore Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Intramuscular Fulvestrant

Intraductal Fulvestrant

Arm Description

500mg fulvestrant administered intramuscularly

up to 500mg fulvestrant administered intraductally

Outcomes

Primary Outcome Measures

Safety and Tolerability of Two Delivery Methods

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

Secondary Outcome Measures

Full Information

NCT ID

NCT02540330

First Posted

August 28, 2015

Last Updated

March 15, 2022

Sponsor

Atossa Therapeutics, Inc.

1. Study Identification

Unique Protocol Identification Number

NCT02540330

Brief Title

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

Acronym

007

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

Study Type

Interventional

2. Study Status

Record Verification Date

March 2022

Overall Recruitment Status

Terminated

Why Stopped

Business decision

Study Start Date

March 2016 (Actual)

Primary Completion Date

August 13, 2020 (Actual)

Study Completion Date

August 13, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Atossa Therapeutics, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Female Breast Carcinoma, Female Ductal Carcinoma In Situ

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

3 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Intramuscular Fulvestrant

Arm Type

Active Comparator

Arm Description

500mg fulvestrant administered intramuscularly

Arm Title

Intraductal Fulvestrant

Arm Type

Experimental

Arm Description

up to 500mg fulvestrant administered intraductally

Intervention Type

Drug

Intervention Name(s)

Fulvestrant

Other Intervention Name(s)

Faslodex

Primary Outcome Measure Information:

Title

Safety and Tolerability of Two Delivery Methods

Description

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

Time Frame

Up to 4 weeks

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Steven C Quay

Organizational Affiliation

Atossa Therapeutics, Inc.

Official's Role

Study Chair

Facility Information:

Facility Name

The Johns Hopkins School of Medicine

City

Baltimore

State/Province

Maryland

ZIP/Postal Code

21205

Country

United States

Facility Name

Montefiore Medical Center

City

New York

State/Province

New York

ZIP/Postal Code

10461

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

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