Estrogen in Postmenopausal Women With ER Positive Metastatic Breast Cancer After Failure of Sequential Endocrine Therapy
Information source: Fox Chase Cancer Center
Information obtained from ClinicalTrials.gov on October 19, 2009
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Breast Cancer; Cancer of the Breast; Neoplasms, Breast
Intervention: Estrace followed by anastrazole (Drug)
Phase: Phase 2
Status: Recruiting
Sponsored by: Fox Chase Cancer Center Official(s) and/or principal investigator(s):
Ramona Swaby, M.D., Principal Investigator, Affiliation: Fox Chase Cancer Center
Overall contact:
Kathleen Lear, R.N., Phone: 215-214-1511, Email: kathleen.lear@fccc.edu
Summary
Prior to the current standard of care utilizing estrogen deprivation or antiestrogen therapy
to treat hormonally sensitive breast cancers, treatment with pharmacologic doses of estrogen
was a common technique used to treat post-menopausal women with hormone sensitive metastatic
disease that resulted in durable responses with regression of disease. A randomized trial
comparing tamoxifen and pharmacologic doses of estrogen demonstrated similar rates of
response with long-term follow-up data confirming a survival benefit for those treated with
the estrogen preparation. Additional data has shown that post-menopausal women with
hormonally sensitive tumors that have progressed on prior endocrine therapies responded to
treatment with pharmacologic doses of estrogen. These data, coupled with pre-clinical data
that postmenopausal levels of estrogen can be used to cause apoptosis (programmed cell death
within the tumor) and tumor regression in exhaustively treated endocrine resistant disease
form the rationale for the proposed clinical trial. This trial seeks to confirm the
response rate for estrace treatment in a patient population heavily pre-treated with modern
endocrine therapies.
Clinical Details
Official title: A Single Arm Phase II Study of Pharmacologic Dose Estrogen in Postmenopausal Women With Hormone Receptor-Positive Metastatic Breast Cancer After Failure of Sequential Endocrine Therapies
Study design: Treatment, Non-Randomized, Open Label, Single Group Assignment, Safety/Efficacy Study
Primary outcome: Response Rate
Secondary outcome: Progression Free Survival
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Female.
Criteria:
Inclusion Criteria:
- Histologically confirmed estrogen and/or progesterone receptor-positive breast cancer
- Metastatic breast cancer
- Clinically determined measurable disease
- Post-menopausal woman
- Previous clinical benefit from prior anti-estrogen therapies
- Good performance status
Exclusion Criteria:
- Chemotherapy or radiotherapy within 4 weeks 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
Locations and Contacts
Kathleen Lear, R.N., Phone: 215-214-1511, Email: kathleen.lear@fccc.edu
Fox Chase Cancer Center, Philadelphia, Pennsylvania 19111, United States; Recruiting
Kathleen Lear, R.N., Phone: 215-214-1511, Email: kathleen.lear@fccc.edu
Additional Information
Starting date: April 2008
Ending date: May 2012
Last updated: April 17, 2008
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