Status:
TERMINATED
A Pilot Clinical Trial to Evaluate the Biological Activity of Fulvestrant in Breast Ductal Carcinoma in Situ (DCIS)
Lead Sponsor:
University of Southern California
Collaborating Sponsors:
AstraZeneca
Conditions:
Breast Carcinoma
Eligibility:
FEMALE
18+ years
Phase:
PHASE2
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 cance...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
August 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2008
Estimated Enrollment :
4 Patients enrolled
Trial Details
Trial ID
NCT00183963
Start Date
August 1 2006
End Date
June 1 2008
Last Update
May 22 2014
Active Locations (1)
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1
Norris Comprehensive Cancer Center
Los Angeles, California, United States, 90033