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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Georgetown University
ClinicalTrials.gov Identifier:
NCT00661531
First received: April 17, 2008
Last updated: June 11, 2014
Last verified: May 2014
  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 2

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Georgetown University:

Primary Outcome Measures:
  • Progression Free Survival [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Response Rate [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Enrollment: 11
Study Start Date: April 2008
Estimated Study Completion Date: June 2015
Estimated Primary Completion Date: June 2015 (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:
  • Estrace
  • Arimidex

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00661531

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

No publications provided

Responsible Party: Georgetown University
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: June 11, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Georgetown University:
Breast cancer
Metastatic breast cancer
ER positive breast cancer
Hormonal therapy

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases
Estradiol
Polyestradiol phosphate
Estrogens
Estradiol valerate
Estradiol 17 beta-cypionate
Estradiol 3-benzoate
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

ClinicalTrials.gov processed this record on August 01, 2014