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

Breast Carcinoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00183963
• Other study ID #: 1B-03-7
• Status: Terminated
• Phase: Phase 2
• First received: September 12, 2005
• Last updated: May 20, 2014
• Start date: August 2006
• Est. completion date: June 2008

Study information

• Verified date: May 2014
• Source: University of Southern California
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 4
• Est. completion date: June 2008
• Est. primary completion date: June 2008
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Breast Carcinoma
• Breast Neoplasms
• Carcinoma
• Carcinoma in Situ
• Carcinoma, Ductal
• Carcinoma, Ductal, Breast
• Carcinoma, Intraductal, Noninfiltrating

Intervention

Drug:
• Tamoxifen
20mg
• Fulvestrant
250mg
• Fulvestrant
500 mg IM

Locations

Country	Name	City	State
United States	Norris Comprehensive Cancer Center	Los Angeles	California

Sponsors (2)

Lead Sponsor	Collaborator
University of Southern California	AstraZeneca

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	6 months after treatment of last patient enrolled	No
Secondary	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.	6 months after treatment of last patient enrolled	No