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

• ClinicalTrials.gov Identifier: NCT00661531
• Recruitment Status: Terminated
• First Posted: April 18, 2008
• Results First Posted: March 7, 2017
• Last Update Posted: April 12, 2017
• Sponsor: Georgetown University
• Information provided by (Responsible Party): Georgetown University

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Breast Cancer; Cancer of the Breast; Neoplasms, Breast	Drug: Estrace; Drug: Anastrozole	Phase 2

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 11 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (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
• Study Start Date: April 2008
• Actual Primary Completion Date: June 2015
• Actual Study Completion Date: June 2015

Arms and Interventions

Arm	Intervention/treatment
Experimental: 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	Drug: Estrace; Estrace 10 mg three times daily will be administered for 3 months.; 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; Other Name: Arimidex

Outcome Measures

Primary Outcome Measures :

1. Progression Free Survival [ Time Frame: 6 months ]
   Progression free survival is defined as the time from assignment of treatment to the time of disease progression or death from any cause

Secondary Outcome Measures :

1. Response Rate [ Time Frame: 6 months ]
   Response rate was defined per RECIST version 1.0. In this study, response rate was defined as including patients with either a complete response (complete disappearance of all target lesions with changes confirmed by repeat assessments performed no less than 4 weeks after the criteria for response was first met) or a partial response (at least 30% decrease in the sum of the longest diameter of the target lesions)

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

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

Contacts and Locations

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

Sponsors and Collaborators

Georgetown University

Investigators

• Principal Investigator: Claudine Isaacs, M.D.; Lombardi Comprehensive Cancer Center

More Information

• Responsible Party: Georgetown University
• ClinicalTrials.gov Identifier: NCT00661531
• Other Study ID Numbers: FER-BR-030; W81XWH-06-1-0590 ( Other Grant/Funding Number: Department of Defense )
• First Posted: April 18, 2008
• Results First Posted: March 7, 2017
• Last Update Posted: April 12, 2017
• Last Verified: November 2015

Keywords provided by Georgetown University:

Breast cancer; Metastatic breast cancer; ER positive breast cancer; Hormonal therapy

Additional relevant MeSH terms:

Breast Neoplasms; Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Anastrozole; Estradiol; Antineoplastic Agents, Hormonal; Antineoplastic Agents; Aromatase Inhibitors; Steroid Synthesis Inhibitors; Enzyme Inhibitors; Molecular Mechanisms of Pharmacological Action; Estrogen Antagonists; Hormone Antagonists; Hormones, Hormone Substitutes, and Hormone Antagonists; Physiological Effects of Drugs; Estrogens; Hormones