Clinical trial NCT00126464: Fulvestrant or Tamoxifen in Treating Postmenopausal Women Who Are Undergoing Surgery for Ductal Carcinoma in Situ of the Breast
Official title: A Pilot Clinical Trial to Evaluate the Biological Activity of Fulvestrant (Faslodex) in Breast Ductal Carcinoma (DCIS)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Breast Cancer
Keywords: ductal breast carcinoma in situ
breast cancer in situ
Lead sponsor: National Cancer Institute (NCI)
Sponsor class: NIH
First posted: 2005-08-04
Enrollment: 100
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Primary purpose: TREATMENT

Brief summary: RATIONALE: Estrogen can cause the growth of breast cancer cells. Hormone therapy using fulvestrant or tamoxifen may fight breast cancer by blocking the use of estrogen by the tumor cells. Giving fulvestrant or tamoxifen before surgery may be an effective treatment for breast cancer.

PURPOSE: This randomized clinical trial is studying how well giving fulvestrant or tamoxifen works in treating postmenopausal women who are undergoing surgery for ductal carcinoma in situ of the breast.

Detailed description: OBJECTIVES:

Primary

* Determine, preliminarily, the efficacy of neoadjuvant fulvestrant, in terms of molecular changes in markers of the estrogen pathway, cell proliferation and apoptosis, and the epidermal growth factor pathway, in postmenopausal women with newly diagnosed ductal carcinoma in situ of the breast.

Secondary

* Determine the toxicity profile of fulvestrant in these patients.

OUTLINE: This is a randomized, placebo-controlled, pilot, multicenter study. Patients are randomized to 1 of 4 treatment arms.

* Arm I: Patients receive oral placebo once daily on days 1-21.
* Arm II: Patients receive oral tamoxifen once daily on days 1-21.
* Arm III: Patients receive fulvestrant intramuscularly (IM) on day 1.
* Arm IV: Patients receive fulvestrant IM as in arm III but at a higher dose. In all arms, treatment continues in the absence of disease progression or unacceptable toxicity. All patients undergo surgical resection of the tumor on approximately day 21.

PROJECTED ACCRUAL: A total of 100 patients (25 per treatment arm) will be accrued for this study.

Eligibility criteria: DISEASE CHARACTERISTICS:

* Histologically confirmed ductal carcinoma in situ (DCIS) of the breast

  * T0 disease
  * Newly diagnosed disease by minimally invasive biopsy (e.g., a vacuum-assisted large core tool \[mammotome\] or an equivalent method)
* Biopsy tissue available for molecular marker analysis
* Baseline mammography performed within the past 8 weeks
* Hormone receptor status:

  * Not specified

PATIENT CHARACTERISTICS:

Age

* Postmenopausal

Sex

* Female

Menopausal status

* Postmenopausal, as defined by 1 of the following:

  * Age ≥ 60
  * Age ≥ 45 AND amenorrheic for \> 1 year with uterus intact
  * Underwent bilateral oophorectomy
  * Follicle-stimulating hormone and estradiol levels in postmenopausal range

Performance status

* SWOG 0-1

Life expectancy

* Not specified

Hematopoietic

* Absolute granulocyte count ≥ 1,500/mm\^3
* Platelet count ≥ 100,000/mm\^3
* Hemoglobin ≥ 8.0 g/dL

Hepatic

* SGOT and/or SGPT ≤ 2.5 times upper limit of normal (ULN)
* Alkaline phosphatase ≤ 2.5 times ULN
* Bilirubin ≤ 2.0 times ULN

Renal

* Creatinine ≤ 2.0 mg/dL

Cardiovascular

* No history of deep vein thrombosis

Pulmonary

* No history of pulmonary embolism

Other

* Negative pregnancy test (if clinically indicated)
* No peripheral neuropathy \> grade 1
* No underlying medical, psychiatric, or social condition that would preclude study participation

PRIOR CONCURRENT THERAPY:

Biologic therapy

* Not specified

Chemotherapy

* Not specified

Endocrine therapy

* More than 6 months since prior hormonal therapy, including any of the following:

  * Antiestrogens
  * Estrogen
  * Selective estrogen-receptor modulators
  * Progestins
  * Aromatase inhibitors

Radiotherapy

* Not specified

Surgery

* Not specified

Other

* No prior therapy for DCIS

Primary outcomes:
measure: Molecular markers of the estrogen pathway as measured by immunohistochemistry at 3 weeks
Secondary outcomes:
measure: Mammographic breast density as measured by the Madena method at 3 weeks
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Samuel Oschin Comprehensive Cancer Institute at Cedars-Sinai Medical Center
state: California
Study officials:
affiliation: Cedars-Sinai Medical Center
name: Agustin Garcia, MD
role: STUDY_CHAIR
References: