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

Phase 2
18 Years
Not Enrolling
Breast Carcinoma

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Trial Information

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

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

- 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

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Number of Participants With Molecular Changes in Markers of Cell Proliferation and Apoptosis Associated With Treatment

Outcome Description:

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.

Outcome Time Frame:

6 months after treatment of last patient enrolled

Safety Issue:


Principal Investigator

Dennis Holmes

Investigator Role:

Principal Investigator

Investigator Affiliation:

USC/Norris Comprehensive Cancer Center


United States: Food and Drug Administration

Study ID:




Start Date:

August 2006

Completion Date:

June 2008

Related Keywords:

  • Breast Carcinoma
  • Breast Neoplasms
  • Carcinoma
  • Carcinoma in Situ
  • Carcinoma, Intraductal, Noninfiltrating
  • Carcinoma, Ductal, Breast
  • Carcinoma, Ductal



Norris Comprehensive Cancer Center Los Angeles, California  90033