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

NCT ID: NCT00661531

Last Updated: 2017-04-12

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 11 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-04-30
• Study Completion Date: 2015-06-30

Brief 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.

Detailed Description

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.

Conditions

Breast Cancer; Cancer of the Breast; Neoplasms, Breast

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Estrace & Anastrozole

Estrace 10 mg three times a day for 3 months. After 3 months of estrace, the estrace will be stopped and anastrazole 1 mg daily will be administered

Group Type: EXPERIMENTAL

Estrace

Intervention Type: DRUG

Estrace 10 mg three times daily will be administered for 3 months.

Anastrozole

Intervention Type: DRUG

After 3 months of estrace, patients who do not have evidence of disease progression will then be switched to received Anastrozole 1 mg daily as long as their disease benefits from this treatment

Interventions

Estrace

Estrace 10 mg three times daily will be administered for 3 months.

Intervention Type: DRUG

Anastrozole

After 3 months of estrace, patients who do not have evidence of disease progression will then be switched to received Anastrozole 1 mg daily as long as their disease benefits from this treatment

Intervention Type: DRUG

Other Intervention Names

Arimidex

Eligibility 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 </= 2.
• 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Georgetown University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Claudine Isaacs, M.D.

Role: PRINCIPAL_INVESTIGATOR

Lombardi Comprehensive Cancer Center

Locations

Georgetown University Medical Center

Washington D.C., District of Columbia, United States

Cooper Cancer Institute

Voorhees Township, New Jersey, United States

Fox Chase Cancer Center

Philadelphia, Pennsylvania, United States

Countries

United States

Other Identifiers

W81XWH-06-1-0590

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

FER-BR-030

Identifier Type: -

Identifier Source: org_study_id