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A Pilot Clinical Trial to Evaluate the Biological Activity of Fulvestrant in Breast Ductal Carcinoma in Situ (DCIS)

Primary Purpose

Breast Carcinoma

Status
Terminated
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Tamoxifen
Fulvestrant
Fulvestrant
Sponsored by
University of Southern California
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Breast Carcinoma

Eligibility Criteria

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

Inclusion Criteria: Postmenopausal women with newly diagnosed DCIS. Women will be considered to be in menopause if they fall into one of the following groups: Age > 60 Age > 45 with amenorrhea > 1 year with intact uterus Status post bilateral oophorectomies FSH/estradiol levels in postmenopausal range for the institution DCIS must have been diagnosed with a minimally invasive biopsy technique, such as a vacuum-assisted large core tool (Mammotome) or an equivalent method. There must be available tissue from the diagnostic biopsy to perform molecular markers. Baseline mammogram within 8 weeks of study entry. Serum creatinine less than or equal to 2.0 mg/dl. Total bilirubin less than or equal to 2.0 upper limit of normal (ULN), transaminases (SGOT and/or SGPT) and alkaline phosphatase may be up to 2.5 x institutional upper limit of normal (ULN), AGC greater than or equal to 1500, platelets greater than or equal to 100,000, Hemoglobin greater than or equal to 8.0 g/dl Peripheral neuropathy grade 0-1. No prior therapy for DCIS. SWOG performance status of less than or equal to 1 All patients must provide informed written consent Exclusion Criteria: Prior hormonal therapy (antiestrogens, estrogen, SERM's, progestins, or aromatase inhibitors) within 6 months of study entry. Underlying medical, psychiatric or social conditions that would preclude patient from receiving treatment. History of DVT or Pulmonary Embolism

Sites / Locations

  • Norris Comprehensive Cancer Center

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

No Intervention

Active Comparator

Active Comparator

Active Comparator

Arm Label

1

2

3

4

Arm Description

Tamoxifen 20 mg

Fulvestrant 250mg

Fulvestrant 500mg IM

Outcomes

Primary Outcome Measures

Number of Participants With Molecular Changes in Markers of Cell Proliferation and Apoptosis Associated With Treatment
Molecular measures of effect will be measured in tissue obtained at baseline biopsy (paraffin specimen) and on surgical specimen obtained at end of 3 weeks of treatment.

Secondary Outcome Measures

Number of Participants With Changes in Mammographic Density
The mammograms will be scanned and a validated computer based threshold method will be used to determine the mammographic densities.

Full Information

First Posted
September 12, 2005
Last Updated
May 20, 2014
Sponsor
University of Southern California
Collaborators
AstraZeneca
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1. Study Identification

Unique Protocol Identification Number
NCT00183963
Brief Title
A Pilot Clinical Trial to Evaluate the Biological Activity of Fulvestrant in Breast Ductal Carcinoma in Situ (DCIS)
Official Title
A Pilot Clinical Trial to Evaluate the Biological Activity of Fulvestrant in Breast Ductal Carcinoma in Situ (DCIS)
Study Type
Interventional

2. Study Status

Record Verification Date
May 2014
Overall Recruitment Status
Terminated
Why Stopped
Insufficient accrual
Study Start Date
August 2006 (undefined)
Primary Completion Date
June 2008 (Actual)
Study Completion Date
June 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Southern California
Collaborators
AstraZeneca

4. Oversight

5. Study Description

Brief Summary
The subjects in this trial have been diagnosed as having a pre-cancerous disease of the breast called ductal carcinoma in situ (DCIS). This condition is associated with the development of breast cancer in up to 50% of cases. The subjects are being asked to participate in this research study. They are being offered voluntary admission to this study to test the effects of a new investigational drug called Fulvestrant (Faslodex). This drug is approved by the United States Food and Drug Administration (FDA) for the treatment of advanced breast cancer but has not been approved for the treatment of DCIS. However, the FDA has given permission for the drug to be tested in this study. The purpose of this study is to find out if Fulvestrant has any effect on the subject's precancerous changes by comparing samples taken before and after receiving Fulvestrant.

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
4 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
No Intervention
Arm Title
2
Arm Type
Active Comparator
Arm Description
Tamoxifen 20 mg
Arm Title
3
Arm Type
Active Comparator
Arm Description
Fulvestrant 250mg
Arm Title
4
Arm Type
Active Comparator
Arm Description
Fulvestrant 500mg IM
Intervention Type
Drug
Intervention Name(s)
Tamoxifen
Intervention Description
20mg
Intervention Type
Drug
Intervention Name(s)
Fulvestrant
Intervention Description
250mg
Intervention Type
Drug
Intervention Name(s)
Fulvestrant
Intervention Description
500 mg IM
Primary Outcome Measure Information:
Title
Number of Participants With Molecular Changes in Markers of Cell Proliferation and Apoptosis Associated With Treatment
Description
Molecular measures of effect will be measured in tissue obtained at baseline biopsy (paraffin specimen) and on surgical specimen obtained at end of 3 weeks of treatment.
Time Frame
6 months after treatment of last patient enrolled
Secondary Outcome Measure Information:
Title
Number of Participants With Changes in Mammographic Density
Description
The mammograms will be scanned and a validated computer based threshold method will be used to determine the mammographic densities.
Time Frame
6 months after treatment of last patient enrolled

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Postmenopausal women with newly diagnosed DCIS. Women will be considered to be in menopause if they fall into one of the following groups: Age > 60 Age > 45 with amenorrhea > 1 year with intact uterus Status post bilateral oophorectomies FSH/estradiol levels in postmenopausal range for the institution DCIS must have been diagnosed with a minimally invasive biopsy technique, such as a vacuum-assisted large core tool (Mammotome) or an equivalent method. There must be available tissue from the diagnostic biopsy to perform molecular markers. Baseline mammogram within 8 weeks of study entry. Serum creatinine less than or equal to 2.0 mg/dl. Total bilirubin less than or equal to 2.0 upper limit of normal (ULN), transaminases (SGOT and/or SGPT) and alkaline phosphatase may be up to 2.5 x institutional upper limit of normal (ULN), AGC greater than or equal to 1500, platelets greater than or equal to 100,000, Hemoglobin greater than or equal to 8.0 g/dl Peripheral neuropathy grade 0-1. No prior therapy for DCIS. SWOG performance status of less than or equal to 1 All patients must provide informed written consent Exclusion Criteria: Prior hormonal therapy (antiestrogens, estrogen, SERM's, progestins, or aromatase inhibitors) within 6 months of study entry. Underlying medical, psychiatric or social conditions that would preclude patient from receiving treatment. History of DVT or Pulmonary Embolism
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dennis Holmes
Organizational Affiliation
University of Southern California
Official's Role
Principal Investigator
Facility Information:
Facility Name
Norris Comprehensive Cancer Center
City
Los Angeles
State/Province
California
ZIP/Postal Code
90033
Country
United States

12. IPD Sharing Statement

Learn more about this trial

A Pilot Clinical Trial to Evaluate the Biological Activity of Fulvestrant in Breast Ductal Carcinoma in Situ (DCIS)

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