NCT00661531

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
11

participants targeted

Target at below P25 for phase_2 breast-cancer

Timeline
Completed

Started Apr 2008

Longer than P75 for phase_2 breast-cancer

Geographic Reach
1 country

3 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2008

Completed
16 days until next milestone

First Submitted

Initial submission to the registry

April 17, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

April 18, 2008

Completed
7.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2015

Completed
1.8 years until next milestone

Results Posted

Study results publicly available

March 7, 2017

Completed
Last Updated

April 12, 2017

Status Verified

November 1, 2015

Enrollment Period

7.2 years

First QC Date

April 17, 2008

Results QC Date

January 16, 2017

Last Update Submit

March 15, 2017

Conditions

Breast CancerCancer of the BreastNeoplasms, Breast

Keywords

Breast cancerMetastatic breast cancerER positive breast cancerHormonal therapy

Outcome Measures

Primary Outcomes (1)

  • Progression Free Survival

    Progression free survival is defined as the time from assignment of treatment to the time of disease progression or death from any cause

    6 months

Secondary Outcomes (1)

  • Response Rate

    6 months

Study Arms (1)

Estrace & Anastrozole

EXPERIMENTAL

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: EstraceDrug: Anastrozole

Interventions

EstraceDRUG

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

Estrace & Anastrozole
AnastrozoleDRUG

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

Also known as: Arimidex
Estrace & Anastrozole

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Georgetown University Medical Center

Washington D.C., District of Columbia, 20057, United States

Location

Cooper Cancer Institute

Voorhees Township, New Jersey, 08043, United States

Location

Fox Chase Cancer Center

Philadelphia, Pennsylvania, 19111, United States

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

EstradiolAnastrozole

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

EstrenesEstranesSteroidsFused-Ring CompoundsPolycyclic CompoundsEstradiol CongenersGonadal Steroid HormonesGonadal HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsNitrilesOrganic ChemicalsTriazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Results Point of Contact

Title
Dr. Claudine Isaacs
Organization
Georgetown University
isaacsc@georgetown.edu
2024443677

Study Officials

  • Claudine Isaacs, M.D.

    Lombardi Comprehensive Cancer Center

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 17, 2008

First Posted

April 18, 2008

Study Start

April 1, 2008

Primary Completion

June 1, 2015

Study Completion

June 1, 2015

Last Updated

April 12, 2017

Results First Posted

March 7, 2017

Record last verified: 2015-11

Locations

US(3)