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

NCT00183963 | Terminated Phase 2 Results

• 1 other identifier: 1B-03-7
• Study Type: interventional
• Target: 4
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• Number of Participants With Changes in Mammographic Density

  6 months after treatment of last patient enrolled

Study Arms (4)

1

NO INTERVENTION

2

ACTIVE COMPARATOR

Tamoxifen 20 mg

Drug: Tamoxifen

3

ACTIVE COMPARATOR

Fulvestrant 250mg

Drug: Fulvestrant

4

ACTIVE COMPARATOR

Fulvestrant 500mg IM

Drug: Fulvestrant

Interventions

Tamoxifen DRUG

20mg

2

Fulvestrant DRUG

250mg

3

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Southern California: lead
• AstraZeneca: collaborator

Study Sites (1)

Norris Comprehensive Cancer Center

Los Angeles, California, 90033, United States

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Tamoxifen; Fulvestrant

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Stilbenes; Benzylidene Compounds; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Estradiol; Estrenes; Estranes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Estradiol Congeners; Gonadal Steroid Hormones; Gonadal Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists

Limitations and Caveats

Due to insufficient accrual, analysis was not conducted.

Results Point of Contact

• Title: Victoria Soto, Project Specialist, Clinical Investigations Support Office
• Organization: USC Norris Comprehensive Cancer Center

Victoria.Soto@med.usc.edu

323-226-6384

Study Officials

• Dennis Holmes

  University of Southern California

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 12, 2005
• First Posted: September 16, 2005
• Study Start: August 1, 2006
• Primary Completion: June 1, 2008
• Study Completion: June 1, 2008
• Last Updated: May 22, 2014
• Results First Posted: December 6, 2012

Record last verified: 2014-05

Locations

US (1)