NCT00006369

Brief Summary

RATIONALE: Estrogen can stimulate the growth of breast cancer cells. Hormone therapy using ERA-923 may fight breast cancer by blocking the uptake of estrogen by the tumor cells. PURPOSE: Randomized phase II trial to study the effectiveness of ERA-923 in treating postmenopausal women who have metastatic breast cancer that no longer responds to tamoxifen.

Trial Health

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Trial Health Score

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

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

June 1, 2000

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

October 4, 2000

Completed
3.5 years until next milestone

First Posted

Study publicly available on registry

April 2, 2004

Completed
Last Updated

November 6, 2013

Status Verified

October 1, 2001

First QC Date

October 4, 2000

Last Update Submit

November 5, 2013

Conditions

Breast Cancer

Keywords

stage IV breast cancerrecurrent breast cancer

Interventions

ERA-923DRUG

Eligibility Criteria

Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
DISEASE CHARACTERISTICS: Diagnosis of metastatic breast cancer Prior tamoxifen therapy failure within 1 year of study defined as follows: Prior tamoxifen therapy for metastatic disease with prior response and progression of disease while still on treatment or within 1 year of last treatment Prior adjuvant tamoxifen therapy for a minimum of 2 years with subsequent progression of disease while still on treatment or within 1 year of last treatment Postmenopausal Must be amenorrheic for at least 12 months Removal of both ovaries or chemotherapy induced menopause allowed At least 1 bideminsionally measurable lesion No disease restricted only to bone No symptomatic CNS metastases untreated by surgery or radiotherapy Hormone receptor status: Estrogen or progesterone receptor positive PATIENT CHARACTERISTICS: Age: Not specified Menopausal status: Postmenopausal Performance status: ECOG 0-2 Life expectancy: At least 6 months Hematopoietic: Absolute neutrophil count at least 1,500/mm3 Platelet count at least 100,000/mm3 Hemoglobin greater than 9.0 g/dL Hepatic: Bilirubin no greater than 1.5 times upper limit of normal (ULN) AST no greater than 3 times ULN (no greater than 5 times ULN if liver metastases present) PT and PTT no greater than 1.25 times ULN Renal: Creatinine no greater than 1.5 times ULN Cardiovascular: No deep vein thrombosis, retinal vein thrombosis, or stroke within past year No unstable angina or myocardial infarction within past 6 months Pulmonary: No pulmonary embolism within past year Other: Not pregnant or nursing No other major illness or condition that would preclude study PRIOR CONCURRENT THERAPY: Biologic therapy: No concurrent trastuzumab (Herceptin) Chemotherapy: No more than 2 prior chemotherapy regimens, including trastuzumab One regimen in adjuvant setting and one in metastatic setting OR Two regimens in metastatic setting No concurrent chemotherapy Endocrine therapy: See Disease Characteristics At least 6 months since prior raloxifene for osteoporosis No prior hormonal, antiestrogen, or aromatase inhibitors other than tamoxifen for breast cancer At least 4 weeks since prior tamoxifen No concurrent hormonal replacement therapy, other antiestrogens (including raloxifene), aromatase inhibitors, or systemic steroids (except physiologic replacement doses) Radiotherapy: See Disease Characteristics Surgery: See Disease Characteristics Other: At least 4 weeks since prior investigational drug No concurrent warfarin exept low dose warfarin for port maintenance No other concurrent investigational agent No concurrent immunosuppressive therapy

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

Sponsors & Collaborators

Study Sites (1)

H. Lee Moffitt Cancer Center and Research Institute

Tampa, Florida, 33612-9497, United States

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

2-(4-hydroxyphenyl)-3-methyl-1-(4-(2-piperidin-1-yl-ethoxy)-benzyl)-1H-indol-5-ol

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Susan Minton, DO

    H. Lee Moffitt Cancer Center and Research Institute

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 2
Purpose
TREATMENT
Sponsor Type
OTHER

Study Record Dates

First Submitted

October 4, 2000

First Posted

April 2, 2004

Study Start

June 1, 2000

Last Updated

November 6, 2013

Record last verified: 2001-10

Locations

US(1)