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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00131924
Recruitment Status : Terminated (Data Monitoring Committee recommended closure due to poor accrual.)
First Posted : August 19, 2005
Last Update Posted : June 11, 2012
National Cancer Institute (NCI)
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Breast Cancer Biological: esterified estrogens Phase 2

Detailed Description:



  • 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^®).


  • 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 Type : Interventional  (Clinical Trial)
Actual Enrollment : 1 participants
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase II Study of High-Dose Estrogen in Postmenopausal Women With Hormone Receptor-Positive Metastatic Breast Cancer After Failure of Sequential Endocrine Therapies
Study Start Date : March 2004
Actual Primary Completion Date : January 2006
Actual Study Completion Date : January 2006

Resource links provided by the National Library of Medicine

Drug Information available for: Estrogens

Primary Outcome Measures :
  1. Clinical response rate

Secondary Outcome Measures :
  1. Time to disease progression
  2. Toxicity

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No


  • 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



  • 18 and over


  • 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


  • Adequate hematologic function


  • Adequate hepatic function
  • Bilirubin ≤ 1.5 times upper limit of normal
  • No history of hepatic adenoma


  • Adequate renal function
  • No history of hypercalcemia or severe hypocalcemia


  • No history of thrombophlebitis or thromboembolic disorders associated with prior estrogen use
  • No active thrombophlebitis or thromboembolic disorders
  • No history of uncontrolled hypertension


  • 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


Biologic therapy

  • Not specified


  • Prior chemotherapy for metastatic disease allowed
  • Prior adjuvant chemotherapy allowed

Endocrine therapy

  • See Disease Characteristics


  • Prior radiotherapy allowed provided the only site of measurable disease was not irradiated


  • Not specified

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00131924

United States, Illinois
Robert H. Lurie Comprehensive Cancer Center at Northwestern University
Chicago, Illinois, United States, 60611-3013
Sponsors and Collaborators
Northwestern University
National Cancer Institute (NCI)
Principal Investigator: William J. Gradishar, MD Robert H. Lurie Cancer Center

Responsible Party: Northwestern University Identifier: NCT00131924     History of Changes
Other Study ID Numbers: NCI 03B5
First Posted: August 19, 2005    Key Record Dates
Last Update Posted: June 11, 2012
Last Verified: June 2012

Keywords provided by Northwestern University:
recurrent breast cancer
stage IV breast cancer

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases
Estrogens, Esterified (USP)
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs