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

• Register: ClinicalTrials.gov
• Last refreshed on: 17 October 2012
• Main ID: NCT00183963
• Date of registration: 12/09/2005
• Primary sponsor: USC/Norris Comprehensive Cancer Center
• Public title: A Pilot Clinical Trial to Evaluate the Biological Activity of Fulvestrant in Breast Ductal Carcinoma in Situ (DCIS)
• Scientific title: A Pilot Clinical Trial to Evaluate the Biological Activity of Fulvestrant in Breast Ductal Carcinoma in Situ (DCIS)
• Date of first enrolment: January 2007
• Target sample size: 4
• Recruitment status: Terminated
• URL: http://clinicaltrials.gov/show/NCT00183963
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Countries of recruitment

United States

Contacts

• Name: Dennis Holmes
• Affiliation: USC/Norris Comprehensive Cancer Center

Key inclusion & exclusion 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



Age minimum: 18 Years
Age maximum: N/A
Gender: Female

Health Condition(s) or Problem(s) studied

Breast Carcinoma

Intervention(s)

Drug: Fulvestrant

Drug: Tamoxifen

Primary Outcome(s)

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.]

Secondary Outcome(s)

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.]

Secondary ID(s)

1B-03-7

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

AstraZeneca