NCT00126464

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.

Trial Health

55
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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable breast-cancer

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2004

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

August 2, 2005

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 4, 2005

Completed
Last Updated

November 6, 2013

Status Verified

July 1, 2006

First QC Date

August 2, 2005

Last Update Submit

November 5, 2013

Conditions

Breast Cancer

Keywords

ductal breast carcinoma in situbreast cancer in situ

Outcome Measures

Primary Outcomes (1)

  • Molecular markers of the estrogen pathway as measured by immunohistochemistry at 3 weeks

Secondary Outcomes (1)

  • Mammographic breast density as measured by the Madena method at 3 weeks

Interventions

fulvestrantDRUG
tamoxifen citrateDRUG
conventional surgeryPROCEDURE
neoadjuvant therapyPROCEDURE

Eligibility Criteria

Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

Samuel Oschin Comprehensive Cancer Institute at Cedars-Sinai Medical Center

Los Angeles, California, 90048, United States

Location

MeSH Terms

Conditions

Breast NeoplasmsCarcinoma, Intraductal, NoninfiltratingBreast Carcinoma In Situ

Interventions

FulvestrantTamoxifenNeoadjuvant Therapy

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue DiseasesAdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeCarcinoma in SituNeoplasms, Ductal, Lobular, and Medullary

Intervention Hierarchy (Ancestors)

EstradiolEstrenesEstranesSteroidsFused-Ring CompoundsPolycyclic CompoundsEstradiol CongenersGonadal Steroid HormonesGonadal HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsStilbenesBenzylidene CompoundsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsCombined Modality TherapyTherapeutics

Study Officials

  • Agustin Garcia, MD

    Cedars-Sinai Medical Center

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Purpose
TREATMENT
Sponsor Type
OTHER

Study Record Dates

First Submitted

August 2, 2005

First Posted

August 4, 2005

Study Start

November 1, 2004

Last Updated

November 6, 2013

Record last verified: 2006-07

Locations

US(1)