NCT00131924

Brief Summary

RATIONALE: High doses of esterified estrogens may stop the growth of breast cancer cells that no longer respond to hormone therapy. PURPOSE: This phase II trial is studying how well high-dose esterified estrogens work in treating postmenopausal women with metastatic breast cancer that has failed previous hormone therapy.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
1

participants targeted

Target at below P25 for phase_2 breast-cancer

Timeline
Completed

Started Mar 2004

Shorter than P25 for phase_2 breast-cancer

Geographic Reach
1 country

1 active site

Status
terminated

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2004

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

August 16, 2005

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 19, 2005

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2006

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2006

Completed
Last Updated

June 11, 2012

Status Verified

June 1, 2012

Enrollment Period

1.8 years

First QC Date

August 16, 2005

Last Update Submit

June 7, 2012

Conditions

Breast Cancer

Keywords

recurrent breast cancerstage IV breast cancer

Outcome Measures

Primary Outcomes (1)

  • Clinical response rate

Secondary Outcomes (2)

  • Time to disease progression

  • Toxicity

Interventions

esterified estrogensBIOLOGICAL

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
DISEASE CHARACTERISTICS: * Histologically confirmed breast cancer * Metastatic disease * Documented disease progression * Must have received and subsequently failed (due to disease progression) ≥ 2 prior sequential endocrine therapies for treatment of metastatic breast cancer * Disease progression during adjuvant tamoxifen is considered 1 prior therapy * The 2 most recent treatments must have been endocrine agents * At least 1 objective measurable disease parameter * Brain metastases allowed provided both of the following criteria are met: * Brain metastases were previously treated AND are currently stable * Brain metastases are not the only site of metastatic disease * Hormone receptor status * Estrogen and/or progesterone receptor-positive tumor PATIENT CHARACTERISTICS: Age * 18 and over Sex * Female Menopausal status * Postmenopausal, as defined by any of the following: * At least 50 years of age with an intact uterus AND amenorrheic for the past 12 months * At least 50 years of age without a uterus AND follicle-stimulating hormone (FSH) level within postmenopausal range * Under 50 years of age and FSH level within postmenopausal range * Prior bilateral oophorectomy Performance status * ECOG 0-2 Life expectancy * At least 6 months Hematopoietic * Adequate hematologic function Hepatic * Adequate hepatic function * Bilirubin ≤ 1.5 times upper limit of normal * No history of hepatic adenoma Renal * Adequate renal function * No history of hypercalcemia or severe hypocalcemia Cardiovascular * No history of thrombophlebitis or thromboembolic disorders associated with prior estrogen use * No active thrombophlebitis or thromboembolic disorders * No history of uncontrolled hypertension Other * Not pregnant * No undiagnosed abnormal vaginal bleeding * No other serious medical illness * No psychiatric illness that would preclude giving informed consent * No other invasive malignancy within the past 5 years except curatively treated basal cell or squamous cell skin cancer or carcinoma in situ of the cervix PRIOR CONCURRENT THERAPY: Biologic therapy * Not specified Chemotherapy * Prior chemotherapy for metastatic disease allowed * Prior adjuvant chemotherapy allowed Endocrine therapy * See Disease Characteristics Radiotherapy * Prior radiotherapy allowed provided the only site of measurable disease was not irradiated Surgery * Not specified

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

Sponsors & Collaborators

Study Sites (1)

Robert H. Lurie Comprehensive Cancer Center at Northwestern University

Chicago, Illinois, 60611-3013, United States

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Estrogens, Esterified (USP)

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Estradiol CongenersGonadal Steroid HormonesGonadal HormonesHormonesHormones, Hormone Substitutes, and Hormone Antagonists

Study Officials

  • William J. Gradishar, MD

    Robert H. Lurie Cancer Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Masking
NONE
Purpose
TREATMENT
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 16, 2005

First Posted

August 19, 2005

Study Start

March 1, 2004

Primary Completion

January 1, 2006

Study Completion

January 1, 2006

Last Updated

June 11, 2012

Record last verified: 2012-06

Locations

US(1)