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

Study Overview
=================
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.

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

Conditions
-----------------
Breast Cancer

Intervention / Treatment
-----------------
* Biological: esterified estrogens


Participation Criteria
=================
Eligibility 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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Biological: esterified estrogens|nan|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical response rate |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to disease progression |  |  | 
| Toxicity |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
recurrent breast cancer, stage IV breast cancer