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

Purpose

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.

Condition	Intervention	Phase
Breast Carcinoma	Drug: Tamoxifen Drug: Fulvestrant	Phase 2

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	A Pilot Clinical Trial to Evaluate the Biological Activity of Fulvestrant in Breast Ductal Carcinoma in Situ (DCIS)

Resource links provided by NLM:

Genetics Home Reference related topics: breast cancer

MedlinePlus related topics: Breast Cancer Cancer

Drug Information available for: Tamoxifen Tamoxifen citrate Fulvestrant

U.S. FDA Resources

Further study details as provided by USC/Norris Comprehensive Cancer Center:

Primary Outcome Measures:

Number of Participants With Molecular Changes in Markers of Cell Proliferation and Apoptosis Associated With Treatment [ Time Frame: 6 months after treatment of last patient enrolled ] [ Designated as safety issue: No ]
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 [ Time Frame: 6 months after treatment of last patient enrolled ] [ Designated as safety issue: No ]
The mammograms will be scanned and a validated computer based threshold method will be used to determine the mammographic densities.

Enrollment:	4
Study Start Date:	August 2006
Study Completion Date:	June 2008
Primary Completion Date:	June 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
No Intervention: 1
Active Comparator: 2 Tamoxifen 20 mg	Drug: Tamoxifen 20mg
Active Comparator: 3 Fulvestrant 250mg	Drug: Fulvestrant 250mg
Active Comparator: 4 Fulvestrant 500mg IM	Drug: Fulvestrant 500 mg IM

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00183963

Locations

United States, California
Norris Comprehensive Cancer Center
Los Angeles, California, United States, 90033

Sponsors and Collaborators

USC/Norris Comprehensive Cancer Center

AstraZeneca

Investigators

Principal Investigator:

Dennis Holmes

USC/Norris Comprehensive Cancer Center

More Information

No publications provided

Responsible Party:	USC/Norris Comprehensive Cancer Center
ClinicalTrials.gov Identifier:	NCT00183963 History of Changes
Other Study ID Numbers:	1B-03-7
Study First Received:	September 12, 2005
Results First Received:	November 9, 2012
Last Updated:	January 17, 2013
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:

Breast Neoplasms
Carcinoma
Carcinoma in Situ
Carcinoma, Intraductal, Noninfiltrating
Carcinoma, Ductal, Breast
Carcinoma, Ductal
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Adenocarcinoma
Neoplasms, Ductal, Lobular, and Medullary
Tamoxifen

Fulvestrant
Estradiol
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Selective Estrogen Receptor Modulators
Estrogen Receptor Modulators
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Bone Density Conservation Agents
Estrogen Antagonists
Estrogens
Hormones

ClinicalTrials.gov processed this record on May 19, 2013