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Estrogen in Postmenopausal Women With ER Positive Metastatic Breast Cancer After Failure of Sequential Endocrine Therapy
This study is currently recruiting participants.
Verified by Fox Chase Cancer Center, April 2008
Sponsors and Collaborators: Fox Chase Cancer Center
Fox Chase Partners
Kimmel Cancer Center (KCC)
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

Genetics Home Reference related topics: breast cancer
MedlinePlus related topics: Breast Cancer Cancer
Drug Information available for: Anastrozole Depogen Estradiol Estradiol 3-benzoate Estradiol acetate Estradiol cypionate Estradiol dipropionate Estradiol valerate Polyestradiol phosphate
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Non-Randomized, Open Label, Single Group Assignment, Safety/Efficacy Study
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

Further study details as provided by Fox Chase Cancer Center:

Primary Outcome Measures:
  • Response Rate [ Time Frame: 3 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Progression Free Survival [ Time Frame: 3 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 88
Study Start Date: April 2008
Estimated Study Completion Date: May 2012
Estimated Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1: Experimental 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.

  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 measurable disease
  • Post-menopausal woman
  • Previous clinical benefit from prior anti-estrogen therapies
  • Good performance status

Exclusion Criteria:

  • Chemotherapy or radiotherapy within 4 weeks 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00661531

Contacts
Contact: Kathleen Lear, R.N. 215-214-1511 kathleen.lear@fccc.edu

Locations
United States, Pennsylvania
Fox Chase Cancer Center Recruiting
Philadelphia, Pennsylvania, United States, 19111
Contact: Kathleen Lear, R.N.     215-214-1511     kathleen.lear@fccc.edu    
Sponsors and Collaborators
Fox Chase Cancer Center
Fox Chase Partners
Kimmel Cancer Center (KCC)
Investigators
Principal Investigator: Ramona Swaby, M.D. Fox Chase Cancer Center
  More Information

Responsible Party: Fox Chase Cancer Center ( Ramona F. Swaby, M.D. )
Study ID Numbers: W81XWH-06-029, W81XWH-06-1-0590
Study First Received: April 17, 2008
Last Updated: April 17, 2008
ClinicalTrials.gov Identifier: NCT00661531  
Health Authority: United States: Institutional Review Board

Keywords provided by Fox Chase Cancer Center:
Breast cancer
Metastatic breast cancer
ER positive breast cancer
Hormonal therapy

Study placed in the following topic categories:
Anastrozole
Skin Diseases
Estradiol 3-benzoate
Estradiol valerate
Breast Neoplasms
Estradiol 17 beta-cypionate
Polyestradiol phosphate
Estradiol
Breast Diseases

Additional relevant MeSH terms:
Estrogens
Antineoplastic Agents, Hormonal
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists
Enzyme Inhibitors
Hormones
Pharmacologic Actions
Neoplasms
Neoplasms by Site
Therapeutic Uses
Aromatase Inhibitors

ClinicalTrials.gov processed this record on January 15, 2009