ERA-923 in Treating Postmenopausal Women With Metastatic Breast Cancer

November 5, 2013 updated by: H. Lee Moffitt Cancer Center and Research Institute

A Phase II, Randomized, Double-Masked, Multicenter Study of Two Dose Levels of ERA-923 for the Treatment of Metastatic Breast Cancer in Postmenopausal Women Who Have Failed Tamoxifen Therapy

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

OBJECTIVES: I. Compare the efficacy of 2 dose levels of ERA-923 in postmenopausal patients with metastatic breast cancer refractory to tamoxifen. II. Determine the safety and plasma levels of this drug in these patients. III. Determine the impact on quality of life of these patients by this drug.

OUTLINE: This is a randomized, double blind, multicenter study. Patients are randomized to one of two treatment arms receiving different doses of ERA-923. Patients receive oral ERA-923 daily for 48 weeks in the absence of disease progression or unacceptable toxicity. Quality of life is assessed at baseline; at weeks 4, 8, 16, 24, 32, 40, and 48; and then at 4 weeks after last dose. Patients are followed at 4 weeks and then every 3 months thereafter.

PROJECTED ACCRUAL: At total of 36-100 patients (18-50 per arm) will be accrued for this study within 1 year.

Study Type

Interventional

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Florida
      • Tampa, Florida, United States, 33612-9497
        • H. Lee Moffitt Cancer Center and Research Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

H. Lee Moffitt Cancer Center and Research Institute

Collaborators

National Cancer Institute (NCI)

Investigators

  • Study Chair: Susan Minton, DO, H. Lee Moffitt Cancer Center and Research Institute

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2000

Study Registration Dates

First Submitted

October 4, 2000

First Submitted That Met QC Criteria

April 1, 2004

First Posted (Estimate)

April 2, 2004

Study Record Updates

Last Update Posted (Estimate)

November 6, 2013

Last Update Submitted That Met QC Criteria

November 5, 2013

Last Verified

October 1, 2001

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CDR0000068242
  • MCC-12235
  • GENE-C9944-33
  • MCC-IRB-5757
  • W-AR-3077A1-200-US
  • NCI-G00-1871

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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