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

This study has been terminated.
(Insufficient accrual)
Sponsor:
Collaborator:
AstraZeneca
Information provided by (Responsible Party):
University of Southern California
ClinicalTrials.gov Identifier:
NCT00183963
First received: September 12, 2005
Last updated: May 20, 2014
Last verified: May 2014
  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:


Further study details as provided by University of Southern California:

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
University of Southern California
AstraZeneca
Investigators
Principal Investigator: Dennis Holmes University of Southern California
  More Information

No publications provided

Responsible Party: University of Southern California
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: May 20, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Carcinoma
Carcinoma in Situ
Breast Neoplasms
Carcinoma, Ductal
Carcinoma, Ductal, Breast
Carcinoma, Intraductal, Noninfiltrating
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases
Adenocarcinoma
Neoplasms, Ductal, Lobular, and Medullary
Fulvestrant
Tamoxifen
Estradiol
Estrogen Antagonists
Estrogen Receptor Modulators
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Therapeutic Uses
Estrogens
Hormones
Selective Estrogen Receptor Modulators
Bone Density Conservation Agents

ClinicalTrials.gov processed this record on September 30, 2014