← Back to Search

Hormone Therapy

Arm I for Breast Cancer

N/A
Waitlist Available
Led By Robert Livingston
Research Sponsored by University of Arizona
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 1.5 years
Awards & highlights
All Individual Drugs Already Approved
Approved for 5 Other Conditions
No Placebo-Only Group

Summary

RATIONALE: Estrogen can cause the growth of tumor cells. Hormone therapy using therapeutic estradiol may fight breast cancer by lowering the amount of estrogen the body makes. Though estradiol initially produces stimulation of ER+ cancer cells, both laboratory and some clinical experience indicate that it may have the opposite effect on such cells, once they have become resistant to estrogen deprivation. In laboratory models, there is death of the "resistant" population after estradiol treatment, followed by restoration of sensitivity of the remaining cells to estrogen deprivation, as with an aromatase inhibitor. Exemestane may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving therapeutic estradiol together with exemestane may kill more tumor cells. PURPOSE: This clinical trial studies therapeutic estradiol and exemestane in treating post-menopausal patients with hormone receptor-positive metastatic breast cancer

Eligible Conditions
  • Breast Cancer
  • Tumors

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 1.5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 1.5 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Number of Participants With Grade 4 Toxicity
Secondary study objectives
Median Time From Entry on Study to Progression of Disease

Awards & Highlights

All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
Approved for 5 Other Conditions
This treatment demonstrated efficacy for 5 other conditions.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: Arm IExperimental Treatment4 Interventions
Patients receive oral therapeutic estradiol once daily on days 1-3, twice daily on days 4-7, and thrice daily on days 8-90. Beginning on day 98, patients receive oral exemestane once daily in the absence of disease progression or unacceptable toxicity. Also laboratory biomarker analysis and enzyme-linked immunosorbent assay will be taken for correlative studies.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Exemestane
FDA approved
Estradiol
FDA approved

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)NIH
13,938 Previous Clinical Trials
41,024,361 Total Patients Enrolled
943 Trials studying Breast Cancer
1,443,258 Patients Enrolled for Breast Cancer
University of ArizonaLead Sponsor
536 Previous Clinical Trials
159,717 Total Patients Enrolled
23 Trials studying Breast Cancer
1,950 Patients Enrolled for Breast Cancer
Robert LivingstonPrincipal InvestigatorUniversity of Arizona
1 Previous Clinical Trials
2 Total Patients Enrolled
~1 spots leftby Dec 2025