Estrogen in Postmenopausal Women With ER Positive Metastatic Breast Cancer After Failure of Sequential Endocrine Therapy

• Status: Terminated
• Trial end date: 2015-06-01
• Target enrollment: 0
• Participant gender: Female

Summary

This trial seeks to confirm the response rate for estrace treatment in a patients with hormone receptor positive metastatic breast cancer heavily pre-treated with modern endocrine therapies.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Georgetown University
• Treatments: Anastrozole; Estradiol; Estradiol 17 beta-cypionate; Estradiol 3-benzoate; Estradiol valerate; Estrogens; Polyestradiol phosphate

Criteria

Inclusion Criteria:

• Histologically confirmed estrogen and/or progesterone receptor-positive breast cancer metastatic breast cancer

• Clinically determined evaluable disease

• Post-menopausal woman

• Previous clinical benefit from prior anti-estrogen therapies and subsequent failure of at least 2 prior endocrine therapies.

• May have had chemotherapy for adjuvant &/or metastatic disease.

• May have had radiation therapy but not to the only site of disease.

• Ecog performance status
• Life expectancy of > 6 months

Exclusion Criteria:

• Chemotherapy or radiotherapy within 1 week of beginning treatment in the clinical trial

• Brain metastasis

• Prior history of or active thrombophlebitis, deep venous thrombosis or pulmonary embolus

• Current vaginal bleeding

• Hypercalcemia or hypocalcemia

• History of or active hepatic adenoma

• No other malignancies within the past 5 years with the exception of curatively treated basal cell or squamous cell carcinoma of the skin or carcinoma in-situ of the cervix