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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00661531
Recruitment Status : Terminated (Poor accrual)
First Posted : April 18, 2008
Results First Posted : March 7, 2017
Last Update Posted : April 12, 2017
Information provided by (Responsible Party):
Georgetown University

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 Type : Interventional  (Clinical Trial)
Actual Enrollment : 11 participants
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer
Drug Information available for: Anastrozole

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

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)

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

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00661531

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

Responsible Party: Georgetown University Identifier: NCT00661531     History of Changes
Other Study ID Numbers: FER-BR-030
W81XWH-06-1-0590 ( Other Grant/Funding Number: Department of Defense )
First Posted: April 18, 2008    Key Record Dates
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:
Hormones, Hormone Substitutes, and Hormone Antagonists
Hormone Antagonists
Contraceptive Agents, Female
Breast Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases
Polyestradiol phosphate
Estradiol 3-benzoate
Estradiol 17 beta-cypionate
Estradiol valerate
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Aromatase Inhibitors
Steroid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Estrogen Antagonists
Contraceptive Agents
Reproductive Control Agents