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

This study has been terminated.
(Unable to meet accrual goal and Pharmaceutical support was withdrawn for this study.)
Information provided by (Responsible Party):
Fox Chase Cancer Center Identifier:
First received: April 17, 2008
Last updated: June 19, 2013
Last verified: June 2013

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 Fox Chase Cancer Center:

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
Study Completion Date: May 2011
Primary Completion Date: May 2011 (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


Ages Eligible for Study:   18 Years and older
Genders 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
  Contacts and Locations
Please refer to this study by its identifier: 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
Fox Chase Cancer Center
Principal Investigator: Mary Daly, M.D. Fox Chase Cancer Center
  More Information

No publications provided

Responsible Party: Fox Chase Cancer Center 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 19, 2013
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

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases
Polyestradiol phosphate
Estradiol valerate
Estradiol 3-benzoate
Estradiol 17 beta-cypionate
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 processed this record on April 17, 2014