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

Phase II Study of High-Dose Estrogen in Postmenopausal Women With Hormone Receptor-Positive Metastatic Breast Cancer After Failure of Sequential Endocrine Therapies

Status
Terminated
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00131924
Enrollment
1
Registered
2005-08-19
Start date
2004-03-31
Completion date
2006-01-31
Last updated
2012-06-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Cancer

Keywords

recurrent breast cancer, stage IV breast cancer

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.

Interventions

BIOLOGICALesterified estrogens

Sponsors

National Cancer Institute (NCI)
CollaboratorNIH
Northwestern University
Lead SponsorOTHER

Study design

Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion 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

Design outcomes

Primary

MeasureTime frame
Clinical response rate

Secondary

MeasureTime frame
Time to disease progression
Toxicity

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026