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

NCT ID: NCT00183963

Last Updated: 2014-05-22

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 4 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-08-31
• Study Completion Date: 2008-06-30

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.

Conditions

Breast Carcinoma

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

1

Group Type: NO_INTERVENTION

No interventions assigned to this group

2

Tamoxifen 20 mg

Group Type: ACTIVE_COMPARATOR

Tamoxifen

Intervention Type: DRUG

20mg

3

Fulvestrant 250mg

Group Type: ACTIVE_COMPARATOR

Fulvestrant

Intervention Type: DRUG

250mg

4

Fulvestrant 500mg IM

Group Type: ACTIVE_COMPARATOR

Fulvestrant

Intervention Type: DRUG

500 mg IM

Interventions

Tamoxifen

20mg

Intervention Type: DRUG

Fulvestrant

250mg

Intervention Type: DRUG

Fulvestrant

500 mg IM

Intervention Type: DRUG

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

AstraZeneca

INDUSTRY

Sponsor Role: collaborator

University of Southern California

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Dennis Holmes

Role: PRINCIPAL_INVESTIGATOR

University of Southern California

Locations

Norris Comprehensive Cancer Center

Los Angeles, California, United States

Countries

United States

Other Identifiers

1B-03-7

Identifier Type: -

Identifier Source: org_study_id