|
Home
Search
Study Topics
Glossary
|
![]() |
![]() |
|
![]() |
|
![]() |
|
![]() |
![]() |
![]() |
|
![]() |
![]() |
||||||||||||||||||||||||||||||||||||
| Sponsor: | Fox Chase Cancer Center |
|---|---|
| Information provided by: | Fox Chase Cancer Center |
| ClinicalTrials.gov Identifier: | NCT00661531 |
Purpose
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 |
|---|---|---|
|
Breast Cancer Cancer of the Breast Neoplasms, Breast |
Drug: Estrace followed by anastrazole |
Phase II |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| 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: | April 2012 |
| Estimated Primary Completion Date: | December 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: 1 |
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.
Other Names:
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| United States, District of Columbia | |
| Georgetown University Medical Center | |
| Washington, District of Columbia, United States, 20057 | |
| United States, New Jersey | |
| Cooper Cancer Institute | |
| Voorhees, New Jersey, United States, 08043 | |
| United States, Pennsylvania | |
| Fox Chase Cancer Center | |
| Philadelphia, Pennsylvania, United States, 19111 | |
| Principal Investigator: | Ramona Swaby, M.D. | Fox Chase Cancer Center |
More Information
| Responsible Party: | Ramona F. Swaby, M.D., Fox Chase Cancer Center |
| ClinicalTrials.gov Identifier: | NCT00661531 History of Changes |
| Other Study ID Numbers: | FER-BR-030, W81XWH-06-1-0590 |
| Study First Received: | April 17, 2008 |
| Last Updated: | April 7, 2011 |
| Health Authority: | United States: Institutional Review Board |
|
Breast cancer Metastatic breast cancer ER positive breast cancer Hormonal therapy |
|
Breast Neoplasms Neoplasms Neoplasms by Site Breast Diseases Skin Diseases Estradiol Polyestradiol phosphate Estrogens Estradiol valerate Estradiol 3-benzoate Estradiol 17 beta-cypionate Anastrozole Hormones |
Hormones, Hormone Substitutes, and Hormone Antagonists Physiological Effects of Drugs Pharmacologic Actions Contraceptive Agents Reproductive Control Agents Therapeutic Uses Contraceptive Agents, Female Antineoplastic Agents, Hormonal Antineoplastic Agents Aromatase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |