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Aromatase Inhibitor

Exemestane for Breast Cancer

Phase 2

Waitlist Available

Led By Bernardo Bonanni

Research Sponsored by National Cancer Institute (NCI)

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 4-6 weeks

Awards & highlights

Study Summary

This trial is studying how well a lower dose of exemestane works in treating postmenopausal patients with early stage estrogen positive breast cancer.

Eligible Conditions

Breast Cancer

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 4-6 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~4-6 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and 4-6 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Percent Change in Time of Circulating Estradiol SPE in Each Arm

Secondary outcome measures

17 OH Exemestane Tissue Concentration at Surgery

17-OH Exemestane Blood Concentration at Surgery

Androstenedione Tissue Concentration at Surgery

+28 more

Other outcome measures

Proteomic Analysis

Trial Design

3Treatment groups

Experimental Treatment

Group I: Arm III: Exemestane 25 mg QW (exemestane, placebo)Experimental Treatment7 Interventions

Patients receive exemestane PO QD on day 1 and placebo PO QD on days 2-7. Cycles repeat every 7 days for 4-6 weeks in the absence of disease progression or unacceptable toxicity. Patients then undergo surgery on days 29, 36, or 43.

Group II: Arm II: Exemestane 25 TIW (exemestane, placebo)Experimental Treatment7 Interventions

Patients receive exemestane PO QD on days 1, 3, and 5. Patients also receive placebo PO QD on days 2, 4, 6, and 7. Cycles repeat every 7 days for 4-6 weeks in the absence of disease progression or unacceptable toxicity. Patients then undergo surgery on days 29, 36, or 43.

Group III: Arm I: Exemestane 25 mg QDExperimental Treatment6 Interventions

Patients receive exemestane PO QD on days 1-7. Cycles repeat every 7 days for 4-6 weeks in the absence of disease progression or unacceptable toxicity. Patients then undergo surgery on days 29, 36, or 43.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Exemestane

2003

Completed Phase 4

~7880

Therapeutic Conventional Surgery

2005

Completed Phase 3

~9850

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Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)Lead Sponsor

13,657 Previous Clinical Trials

40,933,487 Total Patients Enrolled

940 Trials studying Breast Cancer

1,543,360 Patients Enrolled for Breast Cancer

Bernardo BonanniPrincipal InvestigatorEuropean Institute of Oncology

1 Previous Clinical Trials

109 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does this research project currently accept new participants?

"At this moment, clinicaltrials.gov has not posted that the study is accepting participants. Initially published on December 6th 2016 and with its last update occuring over two months ago, it appears to be inactive; however, there are 2,348 other studies currently looking for volunteers."

Answered by AI

Are there existing accounts of pharmacological research?

"Currently, 59 trials of Pharmacological Study are underway. Of these active studies, 23 are in the advanced phase 3 stage. Although the majority of such trials occur in Pisa, PI, there exist 7767 sites running similar investigations for this particular therapy."

Answered by AI

What is the typical purpose of administering a Pharmacological Study?

"Pharmacological Study is useful for treating postmenopausal symptoms, advance directives, and administering 2-3 years of tamoxifen therapy."

Answered by AI

How many participants are involved in the research project?

"At this time, the study is not actively recruiting patients. Initially posted on December 6th 2016 and most recently updated on December 15 2021, if you are exploring other trials there are currently 2289 clinical studies for breast cancer and 59 pharmacological studies accepting participants."

Answered by AI

What dangers have been identified associated with the implementation of this pharmacological research?

"Based on our internal assessment, this pharmacological study scored a 2 for safety since it is at the Phase 2 stage. That indicates that there are some data points to back up its safety but no evidence has been found yet regarding its efficacy."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Alternative Dosing of Exemestane Before Surgery in Treating Postmenopausal Patients With Stage 0-II Estrogen Positive Breast Cancer

2016. "Alternative Dosing of Exemestane Before Surgery in Treating Postmenopausal Patients With Stage 0-II Estrogen Positive Breast Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02598557.