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

This study has been terminated.
(Data Monitoring Committee recommended closure due to poor accrual.)
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Northwestern University
ClinicalTrials.gov Identifier:
NCT00131924
First received: August 16, 2005
Last updated: June 7, 2012
Last verified: June 2012
  Purpose

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 Intervention Phase
Breast Cancer
Biological: esterified estrogens
Phase 2

Study Type: Interventional
Study Design: Masking: 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

Resource links provided by NLM:


Further study details as provided by Northwestern University:

Primary Outcome Measures:
  • Clinical response rate [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Time to disease progression [ Designated as safety issue: No ]
  • Toxicity [ Designated as safety issue: Yes ]

Enrollment: 1
Study Start Date: March 2004
Study Completion Date: January 2006
Primary Completion Date: January 2006 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00131924

Locations
United States, Illinois
Robert H. Lurie Comprehensive Cancer Center at Northwestern University
Chicago, Illinois, United States, 60611-3013
Sponsors and Collaborators
Northwestern University
Investigators
Principal Investigator: William J. Gradishar, MD Robert H. Lurie Cancer Center
  More Information

No publications provided

Responsible Party: Northwestern University
ClinicalTrials.gov Identifier: NCT00131924     History of Changes
Other Study ID Numbers: NCI 03B5, NU-03B5
Study First Received: August 16, 2005
Last Updated: June 7, 2012
Health Authority: United States: Federal Government

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

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

ClinicalTrials.gov processed this record on August 01, 2014