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

Northwestern University

Status and phase

Terminated

Phase 2

Conditions

Breast Cancer

Treatments

Biological: esterified estrogens

Study type

Interventional

Funder types

Other

NIH

Identifiers

NCT00131924

NU-03B5

NCI 03B5

Details and patient eligibility

About

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.

Full 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.

Enrollment

1 patient

Sex

Female

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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