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

Breast Cancer Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00661531
• Other study ID #: FER-BR-030
• Secondary ID: W81XWH-06-1-0590
• Status: Terminated
• Phase: Phase 2
• First received: April 17, 2008
• Last updated: November 28, 2015
• Start date: April 2008
• Est. completion date: June 2015

Study information

• Verified date: November 2015
• Source: Georgetown University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 11
• Est. completion date: June 2015
• Est. primary completion date: June 2015
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms
• Cancer of the Breast
• Neoplasms, Breast

Intervention

Drug:
• Estrace
Estrace 10 mg three times daily will be administered for 3 months.
• 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

Locations

Country	Name	City	State
United States	Fox Chase Cancer Center	Philadelphia	Pennsylvania
United States	Cooper Cancer Institute	Voorhees	New Jersey
United States	Georgetown University Medical Center	Washington	District of Columbia

Sponsors (1)

Lead Sponsor	Collaborator
Georgetown University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Progression Free Survival		6 months	No
Secondary	Response Rate		6 months	No