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

Sponsors and Collaborators:	Norris Comprehensive Cancer Center AstraZeneca
Information provided by:	Norris Comprehensive Cancer Center
ClinicalTrials.gov Identifier:	NCT00183963

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 II

Genetics Home Reference related topics: breast cancer

MedlinePlus related topics: Breast Cancer Cancer

Drug Information available for: Tamoxifen Ici 182780

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Placebo Control, Single Group Assignment, Safety/Efficacy Study

Further study details as provided by Norris Comprehensive Cancer Center:

Primary Outcome Measures:

The purpose of this pilot study is to obtain preliminary information regarding the effect of fulvestrant on DCIS in terms of molecular changes in markers of the estrogen pathway, cell proliferation and apoptosis, and the EGFR pathway [ Time Frame: Tissue obtained at baseline and after 4 weeks of treatment will be submitted for determination of molecular markers. ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

A secondary endpoint will be to evaluate changes in mammographic density. Clinical endpoints will be clinical response, safety and toxicity. [ Time Frame: A high quality baseline mammogram and a repeat mammogram done at the completion of the study will be required. ] [ Designated as safety issue: No ]

Estimated Enrollment:	100
Study Start Date:	January 2007
Study Completion Date:	June 2008
Primary Completion Date:	June 2008 (Final data collection date for primary outcome measure)

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

Norris Comprehensive Cancer Center

AstraZeneca

Investigators

Principal Investigator:

Dennis Holmes

Norris Comprehensive Cancer Center

More Information

No publications provided

Responsible Party:	University of Southern California ( Dr. Dennis Holmes )
Study ID Numbers:	1B-03-7
Study First Received:	September 12, 2005
Last Updated:	July 3, 2008
ClinicalTrials.gov Identifier:	NCT00183963 History of Changes
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Estrogen Antagonists
Estrogens
Antineoplastic Agents, Hormonal
Skin Diseases
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Fulvestrant
Breast Neoplasms
Hormones
Tamoxifen

Carcinoma
Carcinoma, Ductal
Estrogen Receptor Modulators
Carcinoma in Situ
Carcinoma, Intraductal, Noninfiltrating
Carcinoma, Ductal, Breast
Adenocarcinoma
Breast Diseases
Neoplasms, Glandular and Epithelial

Additional relevant MeSH terms:

Estrogen Antagonists
Neoplasms by Histologic Type
Antineoplastic Agents, Hormonal
Skin Diseases
Antineoplastic Agents
Hormone Antagonists
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists
Fulvestrant
Breast Neoplasms
Pharmacologic Actions

Carcinoma
Estrogen Receptor Modulators
Neoplasms
Neoplasms by Site
Therapeutic Uses
Carcinoma, Intraductal, Noninfiltrating
Neoplasms, Ductal, Lobular, and Medullary
Adenocarcinoma
Breast Diseases
Neoplasms, Glandular and Epithelial

ClinicalTrials.gov processed this record on May 07, 2009