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

Breast Cancer Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00131924
• Other study ID #: NCI 03B5
• Secondary ID: NU-03B5
• Status: Terminated
• Phase: Phase 2
• First received: August 16, 2005
• Last updated: June 7, 2012
• Start date: March 2004
• Est. completion date: January 2006

Study information

• Verified date: June 2012
• Source: Northwestern University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 1
• Est. completion date: January 2006
• Est. primary completion date: January 2006
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Study Design

Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Biological:
• esterified estrogens

Locations

Country	Name	City	State
United States	Robert H. Lurie Comprehensive Cancer Center at Northwestern University	Chicago	Illinois

Sponsors (2)

Lead Sponsor	Collaborator
Northwestern University	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clinical response rate			No
Secondary	Time to disease progression			No
Secondary	Toxicity			Yes