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Sponsors and Collaborators: |
Fox Chase Cancer Center Fox Chase Partners Kimmel Cancer Center (KCC) |
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Information provided by: | Fox Chase Cancer Center |
ClinicalTrials.gov Identifier: | NCT00661531 |
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.
Condition | Intervention | Phase |
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Breast Cancer Cancer of the Breast Neoplasms, Breast |
Drug: Estrace followed by anastrazole |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Single Group Assignment, Safety/Efficacy Study |
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 |
Estimated Enrollment: | 88 |
Study Start Date: | April 2008 |
Estimated Study Completion Date: | May 2012 |
Estimated Primary Completion Date: | December 2011 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental |
Drug: Estrace followed by anastrazole
Estrace 10 mg three times daily will be administered for 3 months. Patients who have a response and do not progress on this treatment will then be switched to treatment with anastrazole 1 mg daily for as long as their disease benefits from this treatment.
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Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Kathleen Lear, R.N. | 215-214-1511 | kathleen.lear@fccc.edu |
United States, Pennsylvania | |
Fox Chase Cancer Center | Recruiting |
Philadelphia, Pennsylvania, United States, 19111 | |
Contact: Kathleen Lear, R.N. 215-214-1511 kathleen.lear@fccc.edu |
Principal Investigator: | Ramona Swaby, M.D. | Fox Chase Cancer Center |
Responsible Party: | Fox Chase Cancer Center ( Ramona F. Swaby, M.D. ) |
Study ID Numbers: | W81XWH-06-029, W81XWH-06-1-0590 |
Study First Received: | April 17, 2008 |
Last Updated: | April 17, 2008 |
ClinicalTrials.gov Identifier: | NCT00661531 |
Health Authority: | United States: Institutional Review Board |
Breast cancer Metastatic breast cancer ER positive breast cancer Hormonal therapy |
Anastrozole Skin Diseases Estradiol 3-benzoate Estradiol valerate Breast Neoplasms |
Estradiol 17 beta-cypionate Polyestradiol phosphate Estradiol Breast Diseases |
Estrogens Antineoplastic Agents, Hormonal Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Physiological Effects of Drugs Hormones, Hormone Substitutes, and Hormone Antagonists Enzyme Inhibitors |
Hormones Pharmacologic Actions Neoplasms Neoplasms by Site Therapeutic Uses Aromatase Inhibitors |