High-Dose Esterified Estrogens in Treating Postmenopausal Women With Metastatic Breast Cancer That Has Failed Previous Hormone Therapy

Phase 2

Terminated

• Conditions: Breast Cancer

• Registration Number: NCT00131924
• Lead Sponsor: Northwestern University

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.

Detailed Description

OBJECTIVES:

Primary

* Determine the clinical response rate in postmenopausal women with estrogen and/or progesterone receptor-positive metastatic breast cancer that has failed prior sequential endocrine therapy treated with high-dose esterified estrogens (Menest\^®).

Secondary

* Determine time to disease progression in patients treated with this drug.

* Determine the toxic effects of this drug in these patients.

OUTLINE: Patients receive oral high-dose esterified estrogens (Menest\^®) 3 times daily. Treatment continues in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed for 2 months.

PROJECTED ACCRUAL: A total of 18-35 patients will be accrued for this study within 2 years.

Study Timeline

• Study Start: 2004-03
• Study First Submitted: 2005-08-16
• Study First Submitted QC: 2005-08-16
• Study First Posted: 2005-08-19
• Primary Completion: 2006-01
• Study Completion: 2006-01
• Disposition First Submitted: 2011-02-18
• Disposition First Submitted QC: 2011-02-18
• Disposition First Posted: 2011-02-25
• Status Verified: 2012-06
• Last Update Submitted: 2012-06-07
• Last Update Posted: 2012-06-11

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Female
• Target Recruitment: 1

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Clinical response rate

Secondary Outcome Measures

Name	Time	Method
Time to disease progression
Toxicity

Trial Locations

Locations (1)

Robert H. Lurie Comprehensive Cancer Center at Northwestern University; 🇺🇸 Chicago, Illinois, United States